intra-uteriene ballontamponade bij HPP
Uitgangsvraag
Wat is de rol van intra-uteriene ballon tamponade in vergelijking met radiologische embolisatie bij haemorrhagia postpartum?
Aanbeveling
Overweeg in eerste instantie het plaatsen van een postpartum intra-uteriene ballon, in combinatie met het continueren van uterotonica en vaginale packing bij aanhoudend vaginaal bloedverlies postpartum.
Houd rekening met het feit dat in een deel van de ballonplaatsingen er alsnog een radiologische embolisatie nodig is. Maak locoregionale afspraken om de beschikbaarheid van deze ingreep te waarborgen.
Zorg altijd, rond elk van beide ingrepen, voor adequate maternale monitoring en supportive care, inclusief passend transfusiebeleid en stollingscorrectie, met IC-zorg waar nodig, zeker in het geval van hemodynamische instabiliteit.
Voor de identificatie van risicofactoren voor HPP en de behandeling van HPP wordt verwezen naar de Fluxus Implementatie Strategie en naar het modelprotocol behandeling van HPP.
Overwegingen
Voor- en nadelen van de interventie en de kwaliteit van het bewijs
Bij de behandeling van aanhoudend bloedverlies postpartum als gevolg van uterusatonie na falen van uterotonica moeten de volgende behandelingsstappen worden afgewogen in termen van voor- en nadelen. De volgende stap in de behandeling zou het plaatsen van een postpartum -ballon kunnen zijn, gecombineerd met voortzetting van uterotonica en vaginale tamponade, als een volgende stap om de bloeding te stoppen. Deze ballon is relatief eenvoudig te plaatsen en observationele studies van lage kwaliteit hebben succespercentages van 70-100% laten zien. In een Nederlandse propensity-matched cohortstudie was het succespercentage 70%. Bijwerkingen zijn relatief zeldzaam en omvatten koorts en infectie. Het alternatief is om radiologische arteriële embolisatie uit te voeren, die de laatste decennia steeds meer wordt gebruikt in welvarende landen met een betere toegang tot interventie radiologie. Deze aanpak vereist geavanceerde logistiek en vaardigheden die niet in alle instellingen aanwezig zijn, ook niet in een hoog-inkomensland als Nederland. Bijwerkingen van radiologische arteriële embolisatie zijn bekkenpijn, postembolisatie-syndroom, sepsis, bloeding, lieshematoom, contrastreacties, longembolie, necrose van uterus of onderste extremiteiten bij minder selectieve embolisatie. Het succespercentage van ballontamponade is met meer dan 70% relatief hoog. Als ballontamponade toch mislukt, wordt vaak overgegaan tot radiologische arteriële embolisatie als volgende stap om aanvullende chirurgische interventie, peripartum hysterectomie en maternale sterfte te voorkomen. Zowel ballontamponade als radiologische interventie moeten gepaard gaan met adequate ondersteunende behandeling, waaronder bloedtransfusie. Daarnaast dient adequate maternale monitoring plaats te vinden, in sommige gevallen op een intensive care unit, zeker wanneer sprake is van hemodynamische instabiliteit. Om adequate zorg te garanderen zal soms verplaatsing naar een hoger zorgechelon nodig zijn.
De algehele kwaliteit van het bewijs is zeer laag. Daarom is er aanzienlijke onzekerheid over het gemeten effect op cruciale uitkomsten. Er is een aanzienlijk risico op ernstige selectiebias, met name door indicatiebias, in de observationele onderzoeken. De studie met de hoogste kwaliteit komt uit Nederland van Ramler et al, en betreft een propensity-score gematchte cohortstudie die randomisatie wil nabootsen om het effect van indicatiebias te verminderen. De gematchte deelnemers kwamen uit een groot, landelijk observationeel cohortonderzoek met gedetailleerde patiëntkenmerken.
Waarden en voorkeuren van patiënten (en evt. hun verzorgers)
Na het falen van uterotonica bij de behandeling van persisterende HPP als gevolg van uterusatonie, is het allereerst belangrijk dat de cliënt wordt uitgelegd dat de interventie niet geslaagd is. Voor sommige vrouwen is het erg ingrijpend als een eerste interventie niet slaagt, wat maakt zij geneigd kunnen zijn weerstand te bieden tegen andere interventies. Het is voor vrouwen daarom van belang dat zij mee worden genomen in de situatie en wat dit voor hen betekent. Gezien het lage bewijs is het belangrijk dat de vrouwen worden meegenomen in de alternatief beschikbare interventies. Indien intra-uteriene ballon tamponade en/of radiologische embolisatie wordt overwogen, moeten de voor- en nadelen/risico’s met de vrouw (en haar partner) worden besproken. Het is belangrijk dat bij HPP tijdig wordt ingegrepen, maar dat dit wel in afstemming met de vrouw gebeurt.
Kosten (middelenbeslag)
Omdat ballontamponade de goedkopere interventie is, wordt vaak aangenomen dat deze ook het meest kosteneffectief is. Dit is echter onduidelijk, omdat beide behandeltrajecten (waaronder ballonmislukkingen) tegen elkaar afgewogen zouden moeten worden. Een dergelijke analyse zou ook een analyse van ondersteunende zorg en getransfundeerde bloedproducten moeten omvatten. Een kosteneffectiviteitsanalyse van het Nederlandse propensity-matched cohort wordt momenteel uitgevoerd en de resultaten zijn in afwachting. Toch lijkt het aangewezen, uit het oogpunt van zinnige zorg in brede zin, in de meeste gevallen te starten met ballontamponade alvorens over te gaan tot embolisatie.
Aanvaardbaarheid, haalbaarheid en implementatie
Gezien de aanzienlijke mortaliteit en ernstige morbiditeit die gepaard gaan met ernstige aanhoudend bloedverlies postpartum wordt de aanvaardbaarheid van beide behandelingsopties over het algemeen hoog geacht, maar studies ontbreken.
Onderbouwing
Achtergrond
Radiological arterial embolization can be used for persistent blood loss after delivery, but is considered a relatively expensive, logistically complex and invasive procedure with a substantial risk of complications. Intrauterine balloon tamponade may be a less invasive alternative, and has the potential to reduce the need for embolization (and thus healthcare costs). However, when intrauterine balloon tamponade turns out to be ineffective, radiological embolization will often still be resorted to. This implies that choosing the balloon as the primary management option might induce a delay in arriving at a definitive treatment, with potentially more serious consequences. It is therefore important to investigate the role of the intrauterine balloon tamponade compared to direct radiological arterial embolization during haemorrhagia postpartum.
Conclusies / Summary of Findings
|
Very low GRADE |
The evidence is very uncertain about the effect of intrauterine balloon tamponade on blood loss when compared with no intervention or direct embolization in patients with postpartum haemorrhagia.
Source: Maher 2016, Quandalle 2021, Ramler 2019. |
|
Very low GRADE |
The evidence is very uncertain about the effect of intrauterine balloon tamponade on shock when compared with no intervention or direct embolization in patients with postpartum haemorrhagia.
Source: Ramler 2019. |
|
Very low GRADE |
The evidence is very uncertain about the effect of intrauterine balloon tamponade on coagulopathy when compared with no intervention or direct embolization in patients with postpartum haemorrhagia.
Source: Othman 2016, Ramler 2019. |
|
Very low GRADE |
The evidence is very uncertain about the effect of intrauterine balloon tamponade on hysterectomy when compared with no intervention or direct embolization in patients with postpartum haemorrhagia.
Source: Gauchotte 2017, Maher 2016, Laas 2012, Othman 2016, Quandalle 2021, Ramler 2019. |
|
Very low GRADE |
The evidence is very uncertain about the effect of intrauterine balloon tamponade on organ dysfunction when compared with no intervention or direct embolization in patients with postpartum haemorrhagia.
Source: Gauchotte 2017. |
|
Very low GRADE |
The evidence is very uncertain about the effect of intrauterine balloon tamponade on maternal death when compared with no intervention or direct embolization in patients with postpartum haemorrhagia.
Source: Laas 2012, Maher 2016, Othman 2016, Ramler 2019. |
|
Very low GRADE |
The evidence is very uncertain about the effect of intrauterine balloon tamponade on blood transfusion when compared with no intervention or direct embolization in patients with postpartum haemorrhagia.
Source: Gauchotte 2017, Maher 2016, Othman 2016, Quandalle 2021. |
|
Very low GRADE |
The evidence is very uncertain about the effect of intrauterine balloon tamponade on the use of additional hemostatic interventions when compared with no intervention or direct embolization in patients with postpartum haemorrhagia.
Source: Gauchotte 2017, Laas 2012, Maher 2016, Othman 2016, Quandalle 2021, Ramler 2019. |
|
Very low GRADE |
The evidence is very uncertain about the effect of intrauterine balloon tamponade on transfer to higher level of care when compared with no intervention or direct embolization in patients with postpartum haemorrhagia.
Source: Laas 2012, Maher 2016, Othman 2016. |
|
Very low GRADE |
The evidence is very uncertain about the effect of intrauterine balloon tamponade on adverse effects when compared with no intervention or direct embolization in patients with postpartum haemorrhagia.
Source: Gauchotte 2017, Laas 2012, Maher 2016. |
|
No GRADE |
No evidence was found regarding the effect of intrauterine balloon tamponade on women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding and PTSD when compared with no intervention or direct embolization in participants with postpartum haemorrhagia.
Source: - |
Samenvatting literatuur
Description of studies
All studies were observational cohort studies: two studies were of retrospective nature and had a before/after design (Gauchotte 2017, Quandalle 2021), one was a prospective cohort study (Maher 2016), one had a mixed prospective and retrospective before/after design (Laas 2012), two were retrospective cohort studies (Othman 2016, Ramler 2019). Ramler 2019 performed an additional analysis with a propensity-score matched cohort that was extracted from the total cohort to correct for selection bias and potential confounders for the association between the use of intrauterine balloon tamponade or radiological arterial embolization, or characteristics considered to be risk factors for the occurrence of the primary outcome measure (composite of peripartum hysterectomy and/or maternal mortality). The data for this Netherlands-based propensity-score matched cohort will be used in the results section.
Two studies included only participants after cesarean section for the indication of placenta previa or low-lying placenta (Maher 2016, Othman 2016), one included only participants after vaginal birth (Quandalle 2021) and three studies included participants after either vaginal or cesarean birth (Gauchotte 2017, Laas 2012, Ramler 2019).
All studies used the main commercially available balloon (Bakri©) as intrauterine balloon intervention, except for Ramler 2019 who mentioned that the type of balloon was not registered specifically, although it was clear that in the study period the same type of balloon was used most commonly. Balloons were inflated with a maximum of 500 mL (Gauchotte 2017, Laas 2012, Othman 2016, Quandalle 2021), or up to the desired volume based on the size and capacity of the uterus until it ‘felt firm’ over the balloon (Maher 2016), or inflation volume was not reported (Ramler 2019). The time that the balloon was left in situ varied per study with times ranging from 11.5 to 48 hours. Ramler 2019 did not report time left in situ.
Various comparisons were used in the studies including vascular ligation, various kinds of compression sutures, and eventually hysterectomy. These interventions and the order in which they were performed differed between studies (evidence tables).
Results
No study data were pooled due to the large variation in study populations, study designs and interventions in the control arms. Therefore, results were reported descriptively.
1. Blood loss
Total blood loss was reported in three studies with data of 373 participants. All participants had blood loss equal to or more than 1000mL. Maher 2016 mentioned a mean blood loss of 1386mL (standard deviation 367mL) in the balloon tamponade group and a mean blood loss of 1705mL (standard deviation 447mL) in the group receiving B-lynch compression sutures and/or uterine artery ligation, in favour of the balloon tamponade group. Confidence intervals were not reported, but the difference was stated to be statistically significant. Quandalle 2021 reported a median blood loss of 2070mL (range 1800 to 2870) in the balloon tamponade group and a median blood loss of 2050mL (range 1600 to 2745) in the group before introduction of the balloon tamponade, this difference was reported to not be statistically significant. Ramler 2019 reported that in the propensity-score matched cohort, both the balloon tamponade group and the embolization group had a median blood loss of 3250mL (range 2500-4000mL).
2. Shock
Ramler 2019 reported on this outcome measure. In the propensity-score matched cohort, 40 out of 50 in the balloon tamponade group and 41 out of 50 in the embolization group showed symptoms of shock. This reflects a relative risk of 0.98 (95% CI 0.81 to 1.18). This difference is not clinically relevant.
3. Coagulopathy
Coagulopathy was reported in two studies. In the study of Othman 2016, none of the 13 participants that received a balloon developed coagulopathy, while in the control group 11 out of 151 participants had coagulopathy. In the propensity-score matched cohort of Ramler 2019, in both groups 18 out of 50 participants developed coagulopathy.
4. Hysterectomy
All six studies investigated the outcome of hysterectomy. In the study of Gauchotte 2017, 91 participants were included after introduction of the balloon of whom in 41 women sulprostone treatment failed and within this group, 38 actually received balloon tamponade. In this period, one woman underwent hysterectomy. In the period before introduction of the balloon, 22 out of 72 failed to respond to sulprostone treatment of whom five had a hysterectomy. For the whole group (i.e., 91 and 72 participants), this resulted in a risk ratio of 0.16 (95% CI 0.02 to 1.32). In the study of Laas 2012, one out of 43 participants that received balloon tamponade underwent hysterectomy compared to three out of 38 participants in the period before introduction of the balloon tamponade. The corresponding risk ratio was 0.29 (95% confidence interval 0.03 to 2.71). Maher 2016 reported that one of 72 participants in the hospital that performed balloon tamponade underwent hysterectomy whereas in the hospital that did not perform balloon tamponade, hysterectomy was performed in two out of 40 participants. This reflects a risk ratio of 0.28 (95% confidence interval 0.03 to 2.97). In the study of Othman 2016, no hysterectomies were performed among the 13 participants that had balloon tamponade, whereas 15 of 151 participants that did not have balloon tamponade underwent hysterectomy, resulting in a risk ratio of 0.35 (95% confidence interval 0.02 to 5.54). Quandalle 2021 reported that two out of 83 participants in the period after introduction of the balloon tamponade underwent hysterectomy while seven out of 78 participants in the period before introduction of the balloon tamponade underwent hysterectomy. The corresponding risk ratio is 0.27 (95% confidence interval 0.06 to 1.25). In the propensity-score matched cohort of Ramler 2019, in both groups six out of 50 participants had a hysterectomy.
Overall, it seems that balloon tamponade decreases the risk of hysterectomy. However, since all studies had small sample sizes, events are rather rare. Moreover, several biases -particularly indication bias- are present, and results therefore have to be interpreted with great caution. Noteworthy, when balloon tamponade was compared to embolization in a propensity-score matched cohort, no difference for the risk of hysterectomy was found.
5. Organ dysfunction
One study reported on this outcome (Gauchotte 2017). In the period after introduction of the balloon, among 91 participants, one developed renal failure and one multiple organ failure. It was not reported if those two participants actually received balloon tamponade. In the period before introduction of the balloon, one out of 74 participants developed renal failure and none multiple organ failure.
6. Maternal death
Maternal death was investigated in four studies with a total of 619 participants (Laas 2012, Maher 2016, Othman 2016, Ramler 2019). In two studies a maternal death occurred: one out of 151 participants in the B-lynch compression sutures arm died while none of 13 in the balloon tamponade arm died (Othman 2016). In the study of Ramler 2019, none of the 100 participants in the propensity-score matched cohort died. In the total cohort, however, two out of 373 participants in the balloon tamponade arm died while no deaths occurred among the 82 participants in the embolization arm.
7. Blood transfusion
Transfusion of blood products was described in four studies covering data of 602 participants (Gauchotte 2017, Maher 2016, Othman 2016, Quandalle 2021). Notably, in the study of Ramler 2019, all participants received blood transfusion since this was an inclusion criterion. In the study of Gauchotte 2017, 37 out of 91 participants in the period after introduction of the balloon received any blood transfusion compared to 25 out of 72 in the period before the balloon was introduced. This resulted in a relative risk of 1.17 (95% CI 0.78 to 1.75). Maher 2016 reported intraoperative blood transfusion in 12 out of 72 and nine out of 40 in the balloon and non-balloon tamponade performing hospitals respectively, reflecting a relative risk of 0.74 (95% confidence interval 0.34 to 1.60). In Othman 2016, no blood transfusions were provided among the 13 participants that had received balloon tamponade, while 11 of 151 participants that had not received balloon tamponade were transfused. This results in a relative risk of 0.47 (95% confidence interval 0.03 to 7.60). Quandalle 2021 reported that 60 out of 83 participants in the period after introduction of the balloon tamponade had blood transfused, while in the period before introduction of the balloon this was 54 out of 78 participants. This reflects a relative risk of 1.04 (95% confidence interval 0.86 to 1.27).
8. Use of additional hemostatic interventions
Different types of additional hemostatic interventions were used in the studies. Results regarding additional hemostatic interventions are difficult to interpret as flowcharts for the management of persistent blood loss differed per study.
• Vascular ligation
Four studies reported on the performance of vascular ligation as an additional hemostatic intervention. Gauchotte 2017 reported that in the period after introduction of the balloon, three of 91 participants had vascular ligation or uterine compression sutures (none of those actually received a balloon) compared to 14 out of 74 in the period before introduction of the balloon. In this period, participants underwent either surgical treatment (vascular ligation or uterine compression sutures) or uterine artery embolization. The risk ratio for undergoing vascular ligation in the group treated with balloon tamponade, compared to those not treated with balloon tamponade, was 0.17 (95% CI 0.05 to 0.58). Laas 2012 reported that two out of 43 participants that had balloon tamponade received additional arterial ligation and/or uterine compression sutures, compared to 22 out of 38 in the group that initially received either embolization or ligation: risk ratio 0.08 (95% confidence interval 0.02 to 0.32) favouring balloon tamponade. Maher 2016 reported that five out of 72 underwent vascular ligation (in addition to B-lynch sutures) in the balloon tamponade group versus two out of 40 in the group initially treated with B-lynch sutures: risk ratio 1.39 (95% confidence interval 0.28 to 6.84). In the propensity-matched cohort of Ramler 2019, no uterine artery ligations were performed among 50 participants in the balloon tamponade group while one out of 50 participants in the embolization group received ligation of the uterine artery: risk ratio 0.33 (95% confidence interval 0.01 to 8.00).
• B-lynch sutures
Three studies reported on the performance of B-lynch compression sutures as an additional hemostatic intervention. Maher 2016 reported that three out of 72 participants in the balloon tamponade group had B-lynch sutures compared to four out of 40 in the non-balloon group: risk ratio 0.42 (95% confidence interval 0.10 to 1.77). Othman 2016 reported that none of the 13 participants that had balloon tamponade received B-lynch sutures, whereas seven out of 151 participants that did not receive balloon tamponade had B-lynch sutures: risk ratio 0.72 (95% confidence interval 0.04 to 12.02). Ramler 2019 reported that in both groups two out of 50 participants received B-lynch sutures.
• Re-surgery / surgical revision
Three studies reported on surgery (Re-laparotomy) as an additional hemostatic intervention. Gauchotte 2017 reported that none of 91 participants in the period after introduction of balloon tamponade needed second surgical revision while one of the 74 participants in the period before balloon tamponade needed second surgical revision: risk ratio 0.27 (95% confidence interval 0.01 to 6.57). In the study of Maher 2016, no re-surgeries were performed among 72 and 40 participants in the intervention and control groups respectively. Quandalle 2021 reported that in the balloon tamponade group 16 out of 83 participants had conservative surgical treatment compared to 13 out of 78 in the period before introduction of the balloon, when embolization was performed. This corresponds to a risk ratio of 1.16 (95% confidence interval 0.60 to 2.25).
• No additional intervention (success rate)
|
Study |
Number of participants that received balloon tamponade |
Number of participants that did not need an intervention after balloon tamponade |
Success rate |
|
Gauchotte, 2017 |
38 |
35 |
92.1% |
|
Laas, 2012 |
31 |
26 |
83.8% |
|
Maher, 2016 |
72 |
63 |
87.5% |
|
Othman, 2016 |
13 |
13 |
100% |
|
Quandalle, 2021 |
82 |
64 |
78.0% |
|
Ramler, 2019 |
373 |
262 |
70.2% |
9. Transfer to higher level of care
Three studies reported on this outcome. Laas 2012 reported that all participants with successful tamponade (37 out of 43) were transferred to the intensive care unit. Maher 2016 reported that six out of 72 in the balloon tamponade arm and six out of 40 in the control arm receiving B-lynch stitches and/or uterine artery ligation were admitted to the intensive care unit. This reflects a risk ratio of 0.56 (95% confidence interval 0.19 to 1.61). In the study of Othman 2016, all participants stayed in the intensive care unit.
10. Adverse effects
Adverse effects of the intervention were reported in three studies (Gauchotte 2017, Laas 2012, Maher 2016). Gauchotte 2017 reported that among the 91 participants that were included in the period after the introduction of the ballon tamponade, six developed fever, four subcutaneous hematoma, one thromboembolic event and one bladder injury. It was unknown if those participants actually had balloon tamponade. Among the 74 participants without balloon tamponade, three developed fever, one subcutaneous hematoma, one thromboembolic event, one intestinal obstruction and one Sheehan syndrome. Laas 2012 reported one endometritis among the 43 participants who received intrauterine balloon tamponade and no other adverse outcomes. Maher 2016 reported no major complications related to the postpartum balloon tamponade in their cohort.
11. Women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, PTSD
These outcomes measures were not reported in any of the studies.
Level of evidence of the literature
The level of evidence regarding the outcome measure Blood loss was downgraded to very low because of study limitations (risk of bias) and conflicting results (inconsistency).
The level of evidence regarding the outcome measure Shock was downgraded to very low because of study limitations (risk of bias) and number of included patients (imprecision) and number of events (imprecision).
The level of evidence regarding the outcome measure Coagulopathy was downgraded to very low because of study limitations (risk of bias) and number of included patients and events (imprecision) and wide confidence intervals (imprecision).
The level of evidence regarding the outcome measure Hysterectomy was downgraded to very low because of study limitations (risk of bias) and number of included patients and events (imprecision) and wide confidence intervals (imprecision).
The level of evidence regarding the outcome measure Organ dysfunction was downgraded to very low because of study limitations (risk of bias) and number of included patients (imprecision) and number of events (imprecision).
The level of evidence regarding the outcome measure Maternal death was downgraded to very low because of study limitations (risk of bias) and number of included patients and events (imprecision) and wide confidence intervals (imprecision).
The level of evidence regarding the outcome measure Blood transfusion was downgraded to very low because of study limitations (risk of bias), conflicting results (inconsistency) and number of included patients and events (imprecision).
The level of evidence regarding the outcome measure Use of additional hemostatic intervention was downgraded to very low because of study limitations (risk of bias), conflicting results (inconsistency), applicability (bias due to indirectness) and number of included patients and events (imprecision).
The level of evidence regarding the outcome measure Transfer to higher level of care was downgraded to very low because of study limitations (risk of bias) and number of included patients (imprecision) and number of events (imprecision).
The level of evidence regarding the outcome measure Adverse effects was downgraded to very low because of study limitations (risk of bias), conflicting results (inconsistency) and number of included patients and events (imprecision).
There was no evidence found for the outcome measure Women's sense of wellbeing and thus no level of evidence was determined.
There was no evidence found for the outcome measure Acceptability and satisfaction with the intervention and thus no level of evidence was determined.
There was no evidence found for the outcome measure Breastfeeding and thus no level of evidence was determined.
There was no evidence found for the outcome measure PTSD and thus no level of evidence was determined.
Zoeken en selecteren
A systematic review of the literature was performed to answer the following question: what is the role of intrauterine balloon tamponade compared to direct radiological arterial embolization to treat postpartum haemorrhagia?
| P: | Women with postpartum haemorrhagia |
| I: | Intrauterine balloon tamponade or embolization |
| C: | Other intervention or direct radiological embolization |
| O: |
Blood loss, shock, coagulopathy, hysterectomy, organ dysfunction, maternal death, blood transfusion, use of additional hemostatic intervention, transfer for higher level of care, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, and adverse effects, posttraumatic stress disorder. |
Relevant outcome measures
The guideline development group considered hysterectomy, shock, organ dysfunction, transfer for higher level of care, maternal death and blood transfusion as a critical outcome measure for decision making; and blood loss, coagulopathy, use of any additional hemostatic interventions, women's sense of wellbeing, acceptability and satisfaction with the intervention, breastfeeding, adverse effects and PTSD as an important outcome measure for decision making.
The working group defined the outcome measures as described in the international Delphi consensus study by Meher (2018).
The working group defined a 1% difference as a minimal clinically (patient) important difference for maternal death (RR<0.99 or >1.11) and a 10% difference as a minimal clinically (patient) important difference for the other critical outcomes (RR<0.9 or >1.1). For the important outcomes, a 25% difference for dichotomous outcomes (RR< 0.8 or >1.25) and 0.5 SD for continuous outcomes was taken as minimal clinically (patient) important difference.
Search and select (Methods)
The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms from 1990 until January 29th, 2024. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 374 hits. Studies were selected based on the PICO criteria. Studies were initially selected based on title and abstract screening. After reading the full text, 54 studies were excluded (see the table with reasons for exclusion under the tab Methods), and nine studies met the PICO. Three studies that did meet the PICO criteria were excluded as these were not applicable to Dutch clinical context: two studies assessed uterine balloon tamponade using a Foley catheter, a method applied in low- and middle-income countries where commercially produced postpartum balloons (other than self-constructed condom-based balloons) might not be easily available, and one assessed a self-constructed ‘El-Menia’ balloon not available in the Netherlands. Thus, the literature analysis of this module is based on six studies.
Results
Six studies were included in the analysis of the literature. Important study characteristics and results are summarized in the evidence tables. The assessment of the risk of bias is summarized in the risk of bias tables.
Referenties
- Gauchotte E, De La Torre M, Perdriolle-Galet E, Lamy C, Gauchotte G, Morel O. Impact of uterine balloon tamponade on the use of invasive procedures in severe postpartum hemmorrhagia . Acta Obstet Gynecol Scand. 2017 Jul;96(7):877-882. doi: 10.1111/aogs.13130. Epub 2017 Apr 12. PMID: 28295136.
- Laas E, Bui C, Popowski T, Mbaku OM, Rozenberg P. Trends in the rate of invasive procedures after the addition of the intrauterine tamponade test to a protocol for management of severe postpartum hemmorrhagia . Am J Obstet Gynecol. 2012 Oct;207(4):281.e1-7. doi: 10.1016/j.ajog.2012.08.028. Epub 2012 Aug 17. PMID: 23021688.
- Maher MA, Abdelaziz A. Comparison between two management protocols for postpartum hemmorrhagia during cesarean section in placenta previa: Balloon protocol versus non-balloon protocol. J Obstet Gynaecol Res. 2017 Mar;43(3):447-455. doi: 10.1111/jog.13227. Epub 2016 Dec 17. PMID: 27987342.
- Othman MS, Siddiqui FK, Alahmadi FM, Aljaiar LM. Bakri balloon for the management of placenta previa. IOSR Journal Of Pharmacy. Volume 6, Issue 6 (June 2016), PP. 55-63. (e)-ISSN: 2250-3013, (p)-ISSN: 2319-4219.
- Quandalle A, Ghesquière L, Kyheng M, Ducloy AS, Subtil D, Debarge V, Garabedian C. Impact of intrauterine balloon tamponade on emergency peripartum hysterectomy following vaginal delivery. Eur J Obstet Gynecol Reprod Biol. 2021 Jan;256:125-129. doi: 10.1016/j.ejogrb.2020.10.064. Epub 2020 Nov 2. PMID: 33207298.
- Ramler PI, Henriquez DDCA, van den Akker T, Caram-Deelder C, Groenwold RHH, Bloemenkamp KWM, van Roosmalen J, van Lith JMM, van der Bom JG; TeMpOH-1 study group. Comparison of outcome between intrauterine balloon tamponade and uterine artery embolization in the management of persistent postpartum hemmorrhagia : A propensity score-matched cohort study. Acta Obstet Gynecol Scand. 2019 Nov;98(11):1473-1482. doi: 10.1111/aogs.13679. Epb 2019 Jul 10. PMID: 31240693.
Evidence tabellen
|
Study reference |
Study characteristics |
Patient characteristics |
Intervention (I) |
Comparison / control (C) |
Follow-up |
Outcome measures and effect size |
Comments |
|
Gauchotte, 2017 |
Type of study: retrospective cohort (before /after).
Setting and country: academic hospital in France.
Funding and conflicts of interest: None reported. |
In-/exclusion criteria: All women treated with sulprostone for persistent postpartum hemmorrhagia were included. (sulprostone was administered when bleeding persisted for 15-30 minutes after urinary catheterization, examination of the uterine cavity and birth canal, uterine massage and oxytocin).
N total at baseline: 165 Intervention: 91 Control: 74
Groups comparable at baseline? No |
Bakri balloon tamponade.
|
Management performed prior to introduction of balloon (vascular ligation, uterine compression sutures or uterine artery embolization, and/or hysterectomy).
|
Loss-to-follow-up and incomplete outcome data: 0 |
Rate of uterine artery embolization or surgery: 6.6% in intervention arm and 28.4% in control arm (p<0.01).
Success rate of balloon: 92.1%.
Repeat surgical interventions: 0 in intervention arm and 1 in control arm (p=0.448).
Blood transfusion: 40.7% in intervention arm and 33.8% in control arm (p=0.364).
Maternal complications: 14 in intervention arm and 8 in control arm. |
Only 38 of the 91 participants in the intervention group actually received balloon tamponade: - 50 of 91 did not require further treatment after administration of sulprostone. - 41 of 91 did require further treatment after administration of sulprostone: 3 went directly into surgery and the other 38 received balloon tamponade. |
|
Laas, 2012 |
Type of study: prospective and retrospective cohort (before /after).
Setting and country: tertiary referral university hospital in Germany.
Funding and conflicts of interest: None reported. |
In-/exclusion criteria: All women with postpartum hemmorrhagia because of uterine atony who did not respond to sulprostone were included. (sulprostone was administered when bleeding persisted after 5IU oxytocin, controlled-cord traction, manual placental removal if needed, additional 10IU oxytocin, empty bladder, uterine massage, treatment of tears/episiotomy, administration of crystalloids, colloids and/or blood products).
N total at baseline: 110 Intervention: 72 Control: 38
Groups comparable at baseline? No |
Bakri balloon tamponade.
|
Management performed prior to introduction of balloon (uterine artery embolization or surgical artery ligations, compressive uterine sutures and/or hysterectomy). |
Loss-to-follow-up and incomplete outcome data: unknown, numbers are difficult to check. |
Incidence of embolization: 9.7% in intervention arm and 42.1% in control arm.
Incidence of hysterectomy: 5.6% in intervention arm and 7.9% in control arm.
Incidence of surgical treatment: 36.1% in intervention arm and 57.9% in control arm.
Mortality: 0 in both arms.
Success rate of balloon: 83.8%.
Adverse events: 1 endometritis. |
Only 43 of the 72 participants in the intervention group actually received balloon tamponade. The others: - 24 went directly into surgery - 4 received direct embolization - 1 received direct hysterectomy |
|
Maher, 2016 |
Type of study: prospective cohort.
Setting and country: two tertiary referral hospitals: one military and one public hospital for high-risk women in Saudi Arabia.
Funding and conflicts of interest: None reported. |
In-/exclusion criteria: All women with postpartum hemmorrhagia during elective caesarean for placenta previa or low-lying placenta with persisting blood loss after placental bed (endo-uterine) sutures were included.
N total at baseline: 112 Intervention: 72 Control: 40
Groups comparable at baseline? No |
Bakri balloon tamponade (if bleeding persisted B-lynch stitches, uterine artery ligation and/or hysterectomy).
|
B-lynch stitches, uterine artery ligation and/or hysterectomy. |
Loss-to-follow-up and incomplete outcome data: 0 |
Success rate of balloon: 87.5%.
Need for hysterectomy: 1.4% in intervention arm and 5.0% in control arm (p=0.603).
Mortality: 0 in both arms.
Return to operating room: 0 in both arms.
Total blood loss (mL): 1386 in intervention arm and 1705 in control arm (p=0.000).
Need for blood transfusion: 13.9% in intervention arm and 10.0% in control arm (p=0.764).
ICU admission: 8.3% in intervention arm and 15.0% in control arm (p=0.435).
Adverse events: no major. |
Choice for intervention/ control based on hospital. |
|
Othman, 2016 |
Type of study: retrospective cohort.
Setting and country: tertiary hospital in Saudi Arabia.
Funding and conflicts of interest: None reported. |
In-/exclusion criteria: All women who underwent cesarean for placenta previa and had persisted bleeding of >1000mL after oxytocin, Carboprost and figure 8 stitches were included.
N total at baseline: 164 Intervention: 13 Control: 151
Groups comparable at baseline? No |
Bakri balloon tamponade (if failed: B-lynch stitches, abdominal backing and/or hysterectomy).
|
B-lynch stitches, abdominal backing and/or hysterectomy. |
Loss-to-follow-up and incomplete outcome data: 0 |
Success rate of balloon: 100%.
Need for blood transfusion: 100% in both arms. |
Choice for intervention/ comparison based on preference of obstetrician. |
|
Quandalle, 2021 |
Type of study: retrospective cohort (before /after).
Setting and country: hospital in France.
Funding and conflicts of interest: None reported. |
In-/exclusion criteria: Participants with uterotonic treatment failure with >1L blood loss following vaginal delivery, excluding cases of cesarean section, amniotic embolism, uterine rupture, placenta accreta and postpartum hemmorrhagia due to vaginal laceration.
N total at baseline: 161 Intervention: 83 Control: 78
Groups comparable at baseline? No |
Bakri balloon tamponade (as alternative to embolization in cases of sulprostone failure). |
Before introduction of balloon (technical procedures, uterotonic medical treatment, uterine artery or hypogastric artery embolization, stepwise devascularization following the Tsirulnikov technique, the B-Lynch or Cho hemostatic brace suture, or partial hysterectomy). |
Loss-to-follow-up and incomplete outcome data: 0 |
Incidence of hysterectomy: 2.4% in intervention arm and 9.0% in control arm (p=0.09).
Invasive procedures: 22.9% in intervention arm and 100% in control arm.
Total blood loss (mL): 2070 in intervention arm and 2050 in control arm (p=0.46).
Blood transfusion: 74.1% in intervention arm and 71.1% in control arm (p=0.67). |
Only 82 of the 83 participants in the intervention group actually received balloon tamponade. The other had direct embolization because the obstetrician was unaware of the IUBT technique. |
|
Ramler, 2019 |
Type of study: retrospective cohort with a 1:1 propensity score-matched cohort.
Setting and country: 61 hospitals in the Netherlands.
Funding and conflicts of interest: None reported. |
In-/exclusion criteria: All women with a blood loss of 1000 to 7000mL in 24h after birth for which they received ≥4 packed cells or fresh frozen plasma, or platelets plus packed cells; who were initially managed by intrauterine balloon tamponade or uterine artery embolization during persistent postpartum hemmorrhagia (defined as ongoing hemmorrhagia within the first 24 hours after birth, refractory to first-line therapy and administration of at least one uterotonic agent) were included.
N total at baseline (total/ matched cohort: 455 / 100 Intervention: 373 / 50 Control: 82 / 50
Groups comparable at baseline? Yes |
intrauterine balloon tamponade (mostly Bakri balloon). |
Uterine artery embolization. |
Loss-to-follow-up and incomplete outcome data: |
Peripartum hysterectomy: - total cohort: 5% in intervention arm and 12% in control arm. - matched cohort: 12% in intervention arm and 12% in control arm.
Maternal death: - total cohort: 0.5% in intervention arm and 0% in control arm. - matched cohort: both arms 0%.
Total blood loss (mL): - total cohort: 3500 in intervention arm and 4500 in control arm (p<0.001). - matched cohort: 4500 in intervention arm and 4000 in control arm (p=0.382).
Success rate of balloon (total cohort): 70%. |
|
Risk of Bias tables
Risk of bias table for intervention studies
|
Study reference (first author, year) |
Was the allocation sequence adequately generated?
|
Was the allocation adequately concealed?
|
Blinding:
|
Was loss to follow-up (missing outcome data) infrequent?
|
Are reports of the study free of selective outcome reporting?
|
Was the study apparently free of other problems that could put it at a risk of bias? |
Overall risk of bias
|
|
Gauchotte 2017 |
Definitely no
Reason: Allocation based on period (before / after study). |
Definitely no
Reason: Allocation based on period (before / after study). |
Definitely no
Reason: No blinding. |
Definitely no
Reason: No missing data. |
Probably yes
Reason: All outcome measures mentioned in the methods section are reported. |
Probably no
Reason: Success rate of sulprostone treatment seems to differ between periods. Potentially, participants after introduction of the balloon tamponade were earlier classified as failed to sulprostone treatment. |
High risk of bias
Reason: No randomization, no blinding, before/after design.
|
|
Laas 2012 |
Definitely no
Reason: Allocation based on period (before / after study). |
Definitely no
Reason: Allocation based on period (before / after study). |
Definitely no
Reason: No blinding. |
Unclear
Reason: Numbers are difficult to check. |
Probably yes
Reason: All outcome measures mentioned in the methods section are reported. |
Probably no
Reason: The proportion of cesarean deliveries was higher in the after-period. Data not presented as ‘intention-to-treat’. Unclear why 29 out of 72 participants in the after-period did not receive balloon tamponade. |
High risk of bias
Reason: No randomization, no blinding, before/after design.
|
|
Maher 2016 |
Definitely no
Reason: Allocation based on hospital. |
Definitely no
Reason: Allocation based on hospital. |
Definitely no
Reason: No blinding. |
Definitely no
Reason: No missing data. |
Probably yes
Reason: All outcome measures mentioned in the methods section are reported. |
Probably no
Reason: Different hospitals may lead to differences in population, care providers, protocols, etc. |
High risk of bias
Reason: No randomization, no blinding. |
|
Othman 2016 |
Definitely no
Reason: Allocation based on preference of obstetrician. |
Definitely no
Reason: Allocation based on preference of obstetrician. |
Definitely no
Reason: No blinding. |
Definitely no
Reason: No missing data. |
Probably yes
Reason: All outcome measures mentioned in the methods section are reported. |
Probably no
Reason: Preference of obstetrician and thus treatment arm may be impacted by various confounding factors. |
High risk of bias
Reason: No randomization, no blinding. |
|
Quandalle 2021 |
Definitely no
Reason: Allocation based on period (before / after study). |
Definitely no
Reason: Allocation based on period (before / after study). |
Definitely no
Reason: No blinding. |
Definitely no
Reason: No missing data. |
Probably yes
Reason: All outcome measures mentioned in the methods section are reported. |
Probably yes
Reason: No conflicts of interests or other concerning findings, intention-to-treat analysis. |
High risk of bias
Reason: No randomization, no blinding, before/after design. |
|
Ramler 2019 |
Probably yes
Reason: Matched pairs were created so that both participants had the same chance of receiving the treatment based on a propensity score estimated by a logical regression model including potential confounders for type of treatment and risk factors for occurrence of the primary outcome. |
Not applicable. |
Definitely no
Reason: No blinding |
Probably no
Reason: missing data needed for propensity-score matching was imputed. No missing data in the matched cohort. |
Probably yes
Reason: All outcome measures mentioned in the methods section are reported. |
Probably yes
Reason: No conflicts of interests or other concerning findings. |
Some concerns
Reason: Propensity-score matched cohort.
|
Table of excluded studies
|
Reference |
Reason for exclusion |
|
Anger HA, Dabash R, Durocher J, Hassanein N, Ononge S, Frye LJ, Diop A, Beye SB, Burkhardt G, Darwish E, Ramadan MC, Kayaga J, Charles D, Gaye A, Eckardt M, Winikoff B. The effectiveness and safety of introducing condom-catheter uterine balloon tamponade for postpartum haemorrhage at secondary level hospitals in Uganda, Egypt and Senegal: a stepped wedge, cluster-randomised trial. BJOG. 2019 Dec;126(13):1612-1621. doi: 10.1111/1471-0528.15903. Epub 2019 Sep 18. PMID: 31410966; PMCID: PMC6899652. |
Fulfills PICO criteria, but not translatable to Dutch clinical practice |
|
Dumont A, Bodin C, Hounkpatin B, Popowski T, Traoré M, Perrin R, Rozenberg P. Uterine balloon tamponade as an adjunct to misoprostol for the treatment of uncontrolled postpartum haemorrhage: a randomised controlled trial in Benin and Mali. BMJ Open. 2017 Sep 1;7(9):e016590. doi: 10.1136/bmjopen-2017-016590. PMID: 28864699; PMCID: PMC5589006. |
Fulfills PICO criteria, but not translatable to Dutch clinical practice |
|
Soltan MH, Mohamed A, Ibrahim E, Gohar A, Ragab H. El-menia air inflated balloon in controlling atonic post partum hemmorrhagia . Int J Health Sci (Qassim). 2007 Jan;1(1):53-9. PMID: 21475452; PMCID: PMC3068654. |
Fulfills PICO criteria, but not translatable to Dutch clinical practice |
|
Lo A, St Marie P, Yadav P, Belisle E, Markenson G. The impact of Bakri balloon tamponade on the rate of postpartum hysterectomy for uterine atony. J Matern Fetal Neonatal Med. 2017 May;30(10):1163-1166. doi: 10.1080/14767058.2016.1208742. Epub 2016 Jul 29. PMID: 27364858. |
Wrong design: before/after study (retrospective cohort) |
|
Revert M, Cottenet J, Raynal P, Cibot E, Quantin C, Rozenberg P. Intrauterine balloon tamponade for management of severe postpartum haemorrhage in a perinatal network: a prospective cohort study. BJOG. 2017 Jul;124(8):1255-1262. doi: 10.1111/1471-0528.14382. Epub 2016 Oct 25. PMID: 27781401. |
Wrong design: prospective cohort study |
|
Revert M, Rozenberg P, Cottenet J, Quantin C. Intrauterine Balloon Tamponade for Severe Postpartum Hemmorrhagia . Obstet Gynecol. 2018 Jan;131(1):143-149. doi: 10.1097/AOG.0000000000002405. PMID: 29215522. |
Wrong design: retrospective cohort study |
|
Kong CW, To WWK. Menstrual and reproductive outcomes after use of balloon tamponade for severe postpartum hemmorrhagia . BMC Pregnancy Childbirth. 2018 Nov 21;18(1):451. doi: 10.1186/s12884-018-2085-6. PMID: 30463522; PMCID: PMC6249747. |
Wrong outcome |
|
Lee KJ, Hong K, Hwang H, Choi H, Sohn S. Perspective of the comparative effectiveness of non-pharmacologic managements on postpartum hemmorrhagia using a network meta-analysis. Obstet Gynecol Sci. 2020 Sep;63(5):605-614. doi: 10.5468/ogs.20080. Epub 2020 Jul 30. PMID: 32727171; PMCID: PMC7494765. |
Review, not the most comprehensive |
|
Kellie FJ, Wandabwa JN, Mousa HA, Weeks AD. Mechanical and surgical interventions for treating primary postpartum haemorrhage. Cochrane Database Syst Rev. 2020 Jul 1;7(7):CD013663. doi: 10.1002/14651858.CD013663. PMID: 32609374; PMCID: PMC8407481. |
Review, no correct comparisons with embolization |
|
Pingray V, Widmer M, Ciapponi A, Hofmeyr GJ, Deneux C, Gülmezoglu M, Bloemenkamp K, Oladapo OT, Comandé D, Bardach A, Vázquez P, Cormick G, Althabe F. Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review. BJOG. 2021 Oct;128(11):1732-1743. doi: 10.1111/1471-0528.16819. Epub 2021 Jul 19. PMID: 34165867; PMCID: PMC9292664. |
Review, not the most comprehensive |
|
Mattern J, Sibiude J, Picone O, Mandelbrot L. Efficacité de l’utilisation du ballonnet de tamponnement intra-utérin dans l’hémorragie du post-partum. Étude rétrospective monocentrique avant/après [Efficiency of Bakri intra uterine tamponade balloon use in postpartum hemmorrhagia : Before and after study]. Gynecol Obstet Fertil Senol. 2021 Apr;49(4):239-245. French. doi: 10.1016/j.gofs.2020.11.017. Epub 2020 Nov 20. PMID: 33227496. |
Wrong design: before/after study and full text in French |
|
Burke TF, Shivkumar PV, Priyadarshani P, Garg L, Conde-Agudelo A, Guha M. Impact of the introduction of a low-cost uterine balloon tamponade (ESM-UBT) device for managing severe postpartum hemmorrhagia in India: A comparative before-and-after study. Int J Gynaecol Obstet. 2022 Nov;159(2):466-473. doi: 10.1002/ijgo.14156. Epub 2022 Mar 16. PMID: 35212417. |
Wrong design: before/after study |
|
Doumouchtsis SK, Papageorghiou AT, Vernier C, Arulkumaran S. Management of postpartum hemmorrhagia by uterine balloon tamponade: prospective evaluation of effectiveness. Acta Obstet Gynecol Scand. 2008;87(8):849-55. doi: 10.1080/00016340802179822. PMID: 18704777. |
No comparison, wrong design: prospective audit |
|
Penninx JP, Pasmans HL, Oei SG. Arterial balloon occlusion of the internal iliac arteries for treatment of life-threatening massive postpartum haemorrhage: a series of 15 consecutive cases. Eur J Obstet Gynecol Reprod Biol. 2010 Feb;148(2):131-4. doi: 10.1016/j.ejogrb.2009.10.010. Epub 2009 Dec 3. PMID: 19962226. |
No comparison |
|
Agarwal N, Deinde O, Willmott F, Bojahr H, MacCallum P, Renfrew I, Beski S. A case series of interventional radiology in postpartum haemorrhage. J Obstet Gynaecol. 2011 Aug;31(6):499-502. doi: 10.3109/01443615.2011.566388. PMID: 21823848. |
Wrong design: case series |
|
Kayem G, Kurinczuk JJ, Alfirevic Z, Spark P, Brocklehurst P, Knight M. Specific second-line therapies for postpartum haemorrhage: a national cohort study. BJOG. 2011 Jun;118(7):856-64. doi: 10.1111/j.1471-0528.2011.02921.x. Epub 2011 Mar 10. PMID: 21392247. |
Wrong population, no comparision |
|
Rath W, Hackethal A, Bohlmann MK. Second-line treatment of postpartum haemorrhage (PPH). Arch Gynecol Obstet. 2012 Sep;286(3):549-61. doi: 10.1007/s00404-012-2329-z. Epub 2012 May 4. PMID: 22552376. |
Wrong design: review not systematic |
|
Keriakos R, Chaudhuri S. Operative interventions in the management of major postpartum haemorrhage. J Obstet Gynaecol. 2012 Jan;32(1):14-25. doi: 10.3109/01443615.2011.615418. PMID: 22185528. |
Wrong design |
|
Tindell K, Garfinkel R, Abu-Haydar E, Ahn R, Burke TF, Conn K, Eckardt M. Uterine balloon tamponade for the treatment of postpartum haemorrhage in resource-poor settings: a systematic review. BJOG. 2013 Jan;120(1):5-14. doi: 10.1111/j.1471-0528.2012.03454.x. Epub 2012 Aug 13. PMID: 22882240. |
Wrong population, wrong setting |
|
Aibar L, Aguilar MT, Puertas A, Valverde M. Bakri balloon for the management of postpartum hemmorrhagia . Acta Obstet Gynecol Scand. 2013 Apr;92(4):465-7. doi: 10.1111/j.1600-0412.2012.01497.x. Epub 2012 Aug 21. PMID: 22762694. |
No comparison |
|
Grönvall M, Tikkanen M, Tallberg E, Paavonen J, Stefanovic V. Use of Bakri balloon tamponade in the treatment of postpartum hemmorrhagia : a series of 50 cases from a tertiary teaching hospital. Acta Obstet Gynecol Scand. 2013 Apr;92(4):433-8. doi: 10.1111/j.1600-0412.2012.01531.x. Epub 2012 Oct 17. PMID: 22913383. |
Wrong design: case series |
|
Chan LL, Lo TK, Lau WL, Lau S, Law B, Tsang HH, Leung WC. Use of second-line therapies for management of massive primary postpartum hemmorrhagia . Int J Gynaecol Obstet. 2013 Sep;122(3):238-43. doi: 10.1016/j.ijgo.2013.03.027. Epub 2013 Jun 24. PMID: 23806248. |
No comparison |
|
Affronti, G. Giardina, I. Epicoco, G. Luzi, G. Arena, S., Clerici, G. A conservative protocol for the management of postpartum hemmorrhagia . Evaluation of its effectiveness in high risk participants. Italian Journal of Gynaecology and Obstetrics. 2014 |
No comparison |
|
Howard TF, Grobman WA. The relationship between timing of postpartum hemmorrhagia interventions and adverse outcomes. Am J Obstet Gynecol. 2015 Aug;213(2):239.e1-3. doi: 10.1016/j.ajog.2015.04.017. Epub 2015 Apr 23. PMID: 25912302. |
Wrong comparison |
|
Alouini S, Bedouet L, Ramos A, Ceccaldi C, Evrard ML, Khadre K. Évaluation du ballon de Bakri dans les hémorragies graves du post-partum et fertilité ultérieure [Bakri balloon tamponade for severe post-partum haemorrhage: efficiency and fertility outcomes]. J Gynecol Obstet Biol Reprod (Paris). 2015 Feb;44(2):171-5. French. doi: 10.1016/j.jgyn.2014.05.010. Epub 2014 Jun 26. PMID: 24975399. |
No comparison and full text in French |
|
Vintejoux E, Ulrich D, Mousty E, Masia F, Marès P, de Tayrac R, Letouzey V. Success factors for Bakri™ balloon usage secondary to uterine atony: a retrospective, multicentre study. Aust N Z J Obstet Gynaecol. 2015 Dec;55(6):572-7. doi: 10.1111/ajo.12376. Epub 2015 Jul 30. PMID: 26223852. |
No comparison |
|
Likis FE, Sathe NA, Morgans AK, Hartmann KE, Young JL, Carlson-Bremer D, Schorn M, Surawicz T, Andrews J. Management of Postpartum Hemmorrhagia [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2015 Apr. Report No.: 15-EHC013-EF. PMID: 26020092. |
No comparison |
|
Martin E, Legendre G, Bouet PE, Cheve MT, Multon O, Sentilhes L. Maternal outcomes after uterine balloon tamponade for postpartum hemmorrhagia . Acta Obstet Gynecol Scand. 2015 Apr;94(4):399-404. doi: 10.1111/aogs.12591. Epub 2015 Mar 1. PMID: 25604036. |
wrong design: retrospective case series |
|
Morrison JJ, Galgon RE, Jansen JO, Cannon JW, Rasmussen TE, Eliason JL. A systematic review of the use of resuscitative endovascular balloon occlusion of the aorta in the management of hemorrhagic shock. J Trauma Acute Care Surg. 2016 Feb;80(2):324-34. doi: 10.1097/TA.0000000000000913. Erratum in: J Trauma Acute Care Surg. 2016 Mar;80(3):554. Morrison, Jonathan James [corrected to Morrison, Jonathan J]; Jansen, Jan Olaf [corrected to Jansen, Jan O]; Rasmussen, Todd Erik [corrected to Rasmussen, Todd E]. PMID: 26816219. |
Wrong design: systematic review based on case reports and case series |
|
Sentilhes L, Vayssière C, Deneux-Tharaux C, Aya AG, Bayoumeu F, Bonnet MP, Djoudi R, Dolley P, Dreyfus M, Ducroux-Schouwey C, Dupont C, François A, Gallot D, Haumonté JB, Huissoud C, Kayem G, Keita H, Langer B, Mignon A, Morel O, Parant O, Pelage JP, Phan E, Rossignol M, Tessier V, Mercier FJ, Goffinet F. Postpartum hemmorrhagia : guidelines for clinical practice from the French College of Gynaecologists and Obstetricians (CNGOF): in collaboration with the French Society of Anesthesiology and Intensive Care (SFAR). Eur J Obstet Gynecol Reprod Biol. 2016 Mar;198:12-21. doi: 10.1016/j.ejogrb.2015.12.012. Epub 2015 Dec 21. PMID: 26773243. |
wrong publication type: guideline of the French gynecologic society |
|
Kaya B, Guralp O, Tuten A, Unal O, Celik MO, Dogan A. Which uterine sparing technique should be used for uterine atony during cesarean section? The Bakri balloon or the B-Lynch suture? Arch Gynecol Obstet. 2016 Sep;294(3):511-7. doi: 10.1007/s00404-016-4015-z. Epub 2016 Jan 18. PMID: 26781261. |
Wrong comparison |
|
Son M, Einerson BD, Schneider P, Fields IC, Grobman WA, Miller ES. Is There an Association Between Indication for Intrauterine Balloon Tamponade and Balloon Failure? Am J Perinatol. 2017 Jan;34(2):164-168. doi: 10.1055/s-0036-1585084. Epub 2016 Jul 1. PMID: 27367285. |
Wrong comparison |
|
Aderoba AK, Olagbuji BN, Akintan AL, Oyeneyin OL, Owa OO, Osaikhuwuomwan JA. Condom-catheter tamponade for the treatment of postpartum haemorrhage and factors associated with success: a prospective observational study. BJOG. 2017 Oct;124(11):1764-1771. doi: 10.1111/1471-0528.14361. Epub 2016 Oct 11. PMID: 27726298. |
wrong design: evaluation of factors associated with success |
|
Cui R, Lu J, Zhang Z, Bai H. The Feasibility of Conservative Management for Morbidly Adherent Placenta Accidentally Encountered after Vaginal Delivery. Gynecol Obstet Invest. 2017;82(5):494-499. doi: 10.1159/000452667. Epub 2017 Jan 5. PMID: 28052283. |
Wrong design: case series |
|
Barinov SV, Zhukovsky YG, Dolgikh VT, Medyannikova IV. Novel combined strategy of obstetric haemorrhage management during caesarean section using intrauterine balloon tamponade. J Matern Fetal Neonatal Med. 2017 Jan;30(1):29-33. doi: 10.3109/14767058.2015.1126242. Epub 2016 Jun 1. PMID: 26625194. |
Wrong intervention/ comparison |
|
Einerson BD, Son M, Schneider P, Fields I, Miller ES. The association between intrauterine balloon tamponade duration and postpartum hemmorrhagia outcomes. Am J Obstet Gynecol. 2017 Mar;216(3):300.e1-300.e5. doi: 10.1016/j.ajog.2016.10.040. Epub 2016 Nov 4. PMID: 27823918. |
Wrong comparison |
|
Mathur M, Ng QJ, Tagore S. Use of Bakri balloon tamponade (BBT) for conservative management of postpartum haemorrhage: a tertiary referral centre case series. J Obstet Gynaecol. 2018 Jan;38(1):66-70. doi: 10.1080/01443615.2017.1328671. Epub 2017 Aug 6. PMID: 28782399. |
Wrong design: case series |
|
Grange J, Chatellier M, Chevé MT, Paumier A, Launay-Bourillon C, Legendre G, Olivier M, Ducarme G. Predictors of failed intrauterine balloon tamponade for persistent postpartum hemmorrhagia after vaginal delivery. PLoS One. 2018 Oct 26;13(10):e0206663. doi: 10.1371/journal.pone.0206663. PMID: 30365539; PMCID: PMC6203390. |
Wrong design: case series |
|
Puangsricharoen, P. Manchana, T., Conservative surgical management for immediate postpartum hemmorrhagia . Asian Biomedicine. 2019 |
No comparison |
|
Barinov SV, Medjannikova IV, Tirskaya YI, Chuprinin VD, Khilkevich EG, Savelyeva IV, Shamina IV, Borisova AV, Lazareva OV. The use of Zhukovsky vaginal and intrauterine balloons to improve the outcome of postpartum hysterectomies in participants with severe bleeding. J Matern Fetal Neonatal Med. 2020 Sep;33(17):2955-2960. doi: 10.1080/14767058.2019.1566309. Epub 2019 Jan 22. PMID: 30614315. |
Wrong intervention/ comparison |
|
Vogel JP, Wilson AN, Scott N, Widmer M, Althabe F, Oladapo OT. Cost-effectiveness of uterine tamponade devices for the treatment of postpartum hemmorrhagia : A systematic review. Int J Gynaecol Obstet. 2020 Dec;151(3):333-340. doi: 10.1002/ijgo.13393. Epub 2020 Oct 30. PMID: 32976634; PMCID: PMC7756424. |
Wrong comparison and outcome |
|
Dai YM, Wei J, Wang ZQ, Zhang XB, Cheng L, Gu N, Hu YL. [Intrauterine balloon tamponade combined with temporary abdominal aortic balloon occlusion in the management of women with placenta accreta spectrum:a randomized controlled trial]. Zhonghua Fu Chan Ke Za Zhi. 2020 Jul 25;55(7):450-456. Chinese. doi: 10.3760/cma.j.cn112141-20200225-00135. PMID: 32842248. |
Wrong comparison and full text in Chinese |
|
Said Ali A, Faraag E, Mohammed M, Elmarghany Z, Helaly M, Gadallah A, Taymour MA, Ahmad Y, Ibrahim Eissa A, Ibrahim Ogila A, Ali MK, Abou-Taleb HA, Samy A, Abbas AM. The safety and effectiveness of Bakri balloon in the management of postpartum hemmorrhagia : a systematic review. J Matern Fetal Neonatal Med. 2021 Jan;34(2):300-307. doi: 10.1080/14767058.2019.1605349. Epub 2019 Apr 24. PMID: 30957590. |
No comparison |
|
Kallianidis AF, Maraschini A, Danis J, Colmorn LB, Deneux-Tharaux C, Donati S, Gissler M, Jakobsson M, Knight M, Kristufkova A, Lindqvist PG, Vandenberghe G, van den Akker T; INOSS (the International Network of Obstetric Survey Systems). Management of major obstetric hemmorrhagia prior to peripartum hysterectomy and outcomes across nine European countries. Acta Obstet Gynecol Scand. 2021 Jul;100(7):1345-1354. doi: 10.1111/aogs.14113. Epub 2021 Mar 14. PMID: 33719032; PMCID: PMC8360099. |
Wrong intervention/ comparison/ outcome |
|
Habib N, Luton D, Centini G, Renuit I, Birbarah C, Ceccaldi PF. Advanced Interventional Procedures after Intrauterine Tamponade Balloon Insertion in a Tertiary Care Center. J Invest Surg. 2021 Apr;34(4):373-379. doi: 10.1080/08941939.2019.1637976. Epub 2019 Jul 19. PMID: 31322016. |
No comparison |
|
Arakaki T, Matsuoka R, Takita H, Oba T, Nakamura M, Sekizawa A. The routine use of prophylactic Bakri balloon tamponade contributes to blood loss control in major placenta previa. Int J Gynaecol Obstet. 2021 Sep;154(3):508-514. doi: 10.1002/ijgo.13589. Epub 2021 Feb 11. PMID: 33421119. |
Wrong population |
|
Kong CW, To WWK. The Discriminant Use of Intrauterine Balloon Tamponade and Compression Sutures for Management of Major Postpartum Hemmorrhagia : Comparison of Patient Characteristics and Clinical Outcome. Biomed Res Int. 2021 Jan 2;2021:6648829. doi: 10.1155/2021/6648829. PMID: 33490275; PMCID: PMC7801069. |
Wrong comparison |
|
Gibier M, Pauly V, Orleans V, Fabre C, Boyer L, Blanc J. Risk Factors for Intrauterine Tamponade Failure in Postpartum Hemmorrhagia . Obstet Gynecol. 2022 Sep 1;140(3):439-446. doi: 10.1097/AOG.0000000000004888. Epub 2022 Aug 3. PMID: 35926196. |
wrong study design |
|
Radan AP, Schneider S, Zdanowicz JA, Raio L, Mertineit N, Heverhagen JT, Surbek DV. Obstetrical and Fertility Outcomes Following Transcatheter Pelvic Arterial Embolization for Postpartum Hemmorrhagia : A Cohort Follow-Up Study. Life (Basel). 2022 Jun 15;12(6):892. doi: 10.3390/life12060892. PMID: 35743923; PMCID: PMC9228119. |
No comparison |
|
La Verde, M. Riemma, G. Torella, M. Colacurci, N. Annona, S. Conte, A. Simeon, V. Rapisarda, A. M. De Franciscis, P. Morlando, M. Successfulness of the Bakri Intrauterine Balloon For Uterotonic-Unresponsive Postpartum Haemorrhage Treatment: Systematic Review and Meta-Analysis. Eastern Journal of Medicine. 2022 |
No comparison |
|
Xiao C, Wang Y, Zhang N, Sun GQ. Bakri Balloon for Treatment of Postpartum Hemmorrhagia : A Real-World 2016-2020 Study in 279 Women from a Single Center. Med Sci Monit. 2023 Mar 1;29:e938823. doi: 10.12659/MSM.938823. PMID: 36855288; PMCID: PMC9987168. |
Wrong comparison |
|
Futcher F, Moufawad G, Centini G, Hayek J, Tarchichi J, Bakar J, Habib N. Intrauterine Tamponade Balloon for Management of Severe Postpartum Haemorrhage: Does Early Insertion Change the Outcome? A Retrospective Study on Blood Loss. J Clin Med. 2023 Aug 22;12(17):5439. doi: 10.3390/jcm12175439. PMID: 37685506; PMCID: PMC10487974. |
Wrong comparison |
|
Baldwin HJ, Randall DA, Maher R, West SP, Torvaldsen S, Morris JM, Patterson JA. Interventional radiology in obstetric participants: A population-based record linkage study of use and outcomes. Acta Obstet Gynecol Scand. 2023 Mar;102(3):370-377. doi: 10.1111/aogs.14508. Epub 2023 Jan 26. PMID: 36700375; PMCID: PMC9951351. |
No comparison |
|
Doumouchtsis SK, Papageorghiou AT, Arulkumaran S. Systematic review of conservative management of postpartum hemmorrhagia : what to do when medical treatment fails. Obstet Gynecol Surv. 2007 Aug;62(8):540-7. doi: 10.1097/01.ogx.0000271137.81361.93. PMID: 17634155. |
No comparison |
|
Merriam AA, Huang Y, Wright JD, Goffman D, D'Alton ME, Friedman AM. Use of Uterine Tamponade and Interventional Radiology Procedures During Delivery Hospitalizations. Obstet Gynecol. 2020 Mar;135(3):674-684. doi: 10.1097/AOG.0000000000003722. PMID: 32028498; PMCID: PMC7040521. |
Wrong outcome |
|
Rozenberg P, Sentilhes L, Goffinet F, Vayssiere C, Senat MV, Haddad B, Morel O, Garabedian C, Vivanti A, Perrotin F, Kayem G, Azria E, Raynal P, Verspyck E, Sananes N, Gallot D, Bretelle F, Seco A, Winer N, Deneux-Tharaux C; Groupe de Recherche en Obstétrique et Gynécologie. Efficacy of early intrauterine balloon tamponade for immediate postpartum hemmorrhagia after vaginal delivery: a randomized clinical trial. Am J Obstet Gynecol. 2023 Nov;229(5):542.e1-542.e14. doi: 10.1016/j.ajog.2023.05.014. Epub 2023 May 18. PMID: 37209893. |
Wrong comparison |
Verantwoording
Beoordelingsdatum en geldigheid
Publicatiedatum : 12-12-2025
Beoordeeld op geldigheid : 12-12-2025
Algemene gegevens
De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten (www.demedischspecialist.nl/kennisinstituut) en werd gefinancierd door de Stichting Kwaliteitsgelden Medisch Specialisten (SKMS). De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.
Samenstelling werkgroep
Voor het ontwikkelen van de richtlijnmodule is in 2022 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg voor patiënten met haemorrhagia postpartum.
Werkgroep
- Dr. M.(Martina) Porath (voorzitter) (NVOG)
- Dr. H.C.J. (Liesbeth) Scheepers (NVOG)
- Dr. D.D.C.A. (Dacia) Henriquez (NVOG)
- Dr. J.M. (Annemieke) Middeldorp(NVOG)
- Prof. dr. T.H. (Thomas) van den Akker (NVOG)
- Dr. P. (Paul) Ramler (NVOG) (tot September 2023)
- Dr. K.P.M. (Karin) van Galen(NIV)
- Drs. H.W. (Hannah) de Klerk (KNOV)
- Drs. L. (Lianne) Zondag (KNOV)
- Prof. dr. ir. Y.M.C. (Yvonne) Henskens (NVKC)
- Dr. I.C.M. (Ingrid) Beenakkers (NVA)
- Dr. S. (Simone) Willems (NVA)
- Mw. I. (Ilse) van Ee (PFN)
Klankboardgroep
- Drs. K. (Klaartje) Caminada (AZN)
- Mw. B. (Britt) Ketelaars (PFN)
Met ondersteuning van
- Dr. M. (Mohammadreza) Abdollahi, adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
- Dr. I.M. (Irina) Mostovaya, senior adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
- Dr. J. (Jana) Tuijtelaars, adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
- Drs. D.A.M. (Danique) Middelhuis, adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
- Dr. M. (Majke) van Bommel, adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
- Dr. L. (Leanne) Küpers, adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
- Drs. D.A.M. (Fieke) Pepping, junior adviseur, Kennisinstituut van de Federatie van Medisch Specialisten
- Linda Niesink, medisch informatie specialist, Kennisinstituut van de Federatie Medisch Specialisten
- Laura Boerboom, medisch informatie specialist, Kennisinstituut van de Federatie Medisch Specialisten
- Alies Oost, medisch informatie specialist, Kennisinstituut van de Federatie Medisch Specialisten
Belangenverklaringen
Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten via secretariaat@kennisinstituut.nl.
|
Naam |
Hoofdfunctie |
Nevenwerkzaamheden |
Persoonlijke financiële belangen |
Persoonlijke relaties |
Extern gefinancierd onderzoek |
Intellectuele belangen en reputatie |
Overige belangen |
Datum |
Restrictie |
|
Martina Porath |
gynaecoloog-perinatoloog Maxima Medisch Centrum |
Voorzitter focusgroep Acute Verloskunde Noord-Brabant Lid NVOG werkgroep Otterlo |
geen |
geen |
geen |
geen |
geen |
04/28/2025 |
|
|
Liesbeth Scheepers |
perinatoloog MUMC |
Richtlijnen commissie Otterloo groep Voorzitter Regioconsortium Geboortezorg Limburg Vice voorzitter Perinatale audit Limburg |
Geen |
Nee |
ZONMW onderzoek, niet op dit onderwerp |
Nee |
Nee |
04/25/2025 |
|
|
Annemieke Middeldorp |
Gynaecoloog Perinatoloog Leids Universitair Medisch Centrum, gestopt met werken vanaf 2024 |
geen |
geen |
geen |
geen |
geen |
geen |
04/25/2025 |
|
|
Dacia Henriquez |
Gynaecoloog, Perinatoloog, Amphia Ziekenhuis |
Geen |
Geen |
Geen |
Geen |
Geen |
Geen |
04/28/2025 |
|
|
Thomas van den Akker |
Gynaecoloog perinatoloog, LUMC, hoogleraar Verloskunde |
Hoogleraar VU *Global Maternal Health, Athena Instituut. *Perined bestuurslid *RvT Wemos. *FMG Pijlervoorzitter NVOG *Vz working party for international safe motherhood and reproductive health. *Perinatale audit regiovoorzitter. Alles onbetaald. |
Geen |
Geen |
Geen |
Door werk van de commissie komt het werk van mijn voormalig promovendi Ada Gillissen en Paul Ramler meer in de aandacht staan, omdat sommige aanbevelingen hierop gebaseerd zijn (met name van laatstgenoemde ten aanzien van ballon versus embolisatie).
Het feit dat ik als bijdrager op de richtlijn sta kan gezien worden als ten goede komend aan de boegbeeldfunctie die ik bij de NVOG heb, maar het effect hiervan lijkt beperkt in het licht van mijn andere activiteiten. |
Geen |
04/25/2025 |
|
|
Paul Ramler (tot September 2023) |
AIOS Gynaecologie, cluster Leiden |
Geen |
Geen |
Geen |
Geen |
Geen |
Geen |
29/01/2023 |
|
|
Ingrid Beenakkers |
Anesthesioloog, UMCU/WKZ |
geen |
geen |
geen |
geen |
geen |
geen |
04/28/2025 |
|
|
Simone Anna Alexandra Sijm-Willems |
Anesthesioloog Radboudumc |
- |
-zs |
- |
- |
- |
- |
04/25/2025 |
|
|
Karin van Galen |
internist-hematoloog UMC Utrecht |
geen |
geen |
n.v.t. |
Octapharma: Pregnancy and inherited bleeding disorders - unresticted research grant, projectleider. |
Voorzitter Nederlands Zorgnetwerk Vrouwen met een stollingsstoornis. Tot Febr 2025 voorzitter Women and Girls with beleeding Disorders Group European Assosiation for Heamophilia and Alied Disorders - momenteel nog actief lid van deze werkgroep. |
n.v.t. |
04/25/2025 |
|
|
Yvonne Henskens |
Klinisch chemicus, waarnemend hoofd Centraal Diagnostisch Laboratorium Hoogleraar Klinische Chemie ihb Hemostase |
Voorzitter Vereniging Hematologisch Laboratoria 2020-heden Lid Vici beoordelingscie 2022 Lid raad van Advies NVKC 2023-heden Adviseur Promicol 2020-heden |
geen |
geen |
Voor alle studies in het kader van mijn leerstoel worden reagentia of apparatuur gratis of met korting verkregen, hierbij wordt geen enkele IVD methode of bedrijf uitgesloten mits het past in het doel van mijn leerstoel. Noyons stipendium NVKC (prijs) Stago / Validatie van apparatuur en/of reagentia / Ja Siemens / Validatie van apparatuur en/of reagentia / Ja Werfen / Validatie van apparatuur en/of reagentia / N Nodia / Validatie van apparatuur en/of reagentia / Nee Promicol / Validatie van apparatuur en/of reagentia / Nee |
nee |
nee |
04/25/2025 |
|
|
Hannah de Klerk |
Zelfstandig eerstelijns verloskundige (ZZP), betaald PhD aanstelling Amsterdam UMC, locatie VUMc, onbetaald |
Gastdocent HU, betaald Projectleider KNOV, betaald |
geen |
nee |
nee |
nee |
nee |
7/10/2022 |
|
|
Lianne Zondag |
Eerstelijns verloskundige - verloskundige praktijk de Toekomst - Geldermalsen KNOV - senior richtlijnonwikkelaar |
Bestuurslid Netwerk Geboortezorg Rivierenland PhD candidate Maastricht University |
Geen |
Geen |
Geen |
Geen |
Geen |
2/6/2023 |
|
|
Ilse van Ee |
Adviseur Patientenbelang - full time inbreng patientenperspectief |
Ervaringsdeskundige patientvertegenwoordiger - Eupati - fellow Psoriasispatienten Nederland - onbetaald Coordinator Patientenpraticipatie, lid centrale redactie Psoriasispatienten Nederland - onbetaald Eupati mentor - Eupati Nl - onbetaald |
nee |
nvt |
Janssen / Freedom of disease Psoriasis / ja |
nee |
nvt |
04/25/2025 |
|
|
Klaartje Caminada |
Medisch Manager Ambulancezorg, lid protocollencommissie Ambulancezorg Nederland |
geen |
geen |
geen |
geen |
geen |
geen |
04/29/2025 |
|
|
Brit Ketelaars |
Adviseur patiëntbelang bij Patiëntenfederatie Nederland (full time, betaald) |
geen |
geen |
geen |
geen |
geen |
geen |
04/25/2025 |
|
Inbreng patiëntenperspectief
De werkgroep besteedde aandacht aan het patiëntenperspectief door uitnodigen van Patiëntenfederatie Nederland, Geboortebeweging en Het Buikencollectiefvoor de invitational conference. Het verslag hiervan is besproken in de werkgroep. De verkregen input is meegenomen bij het opstellen van de uitgangsvragen, de keuze voor de uitkomstmaten en bij het opstellen van de overwegingen. De conceptrichtlijn is tevens voor commentaar voorgelegd aan Patiëntenfederatie Nederland en de eventueel aangeleverde commentaren zijn bekeken en verwerkt.
Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz
Bij de richtlijnmodule voerde de werkgroep conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uit om te beoordelen of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling is de richtlijnmodule op verschillende domeinen getoetst (zie het stroomschema bij Werkwijze).
Uit de kwalitatieve raming blijkt dat er waarschijnlijk mogelijk substantiële financiële gevolgen zijn, zie onderstaande tabel.
In Nederland bevallen per jaar ca. 160.000 vrouwen. De incidentie van haemorrhagia postpartum is 7 tot 10%. Dit zijn 11.200 tot 16.000 vrouwen per jaar. Het aantal vrouwen met risicofactoren voor HPP is niet bekend.
| Module |
Uitkomst raming |
Toelichting |
|
Intra-uteriene ballontamponade bij HPP |
geen financiële gevolgen |
Beide behandelmethoden zijn geïmplementeerd in Nederland. Er wordt aanbevolen om eerst de ballontamponade toe te passen. Dit is de goedkopere behandeling. |
Werkwijze
Voor meer details over de gebruikte richtlijnmethodologie verwijzen wij u naar de Werkwijze. Relevante informatie voor de ontwikkeling/herziening van deze richtlijnmodule is hieronder weergegeven.
Zoekverantwoording
Zoekstrategie
Embase 14-11-2023
|
No. |
Query |
Results |
|
#1 |
'postpartum hemmorrhagia '/exp OR 'fluxus postpartum':ti,ab,kw OR 'postpartum hemmorrhagia ':ti,ab,kw OR 'post partum haemorrhage':ti,ab,kw OR 'post partum hemmorrhagia ':ti,ab,kw OR 'postpartal haemorrhage':ti,ab,kw OR 'postpartal hemmorrhagia ':ti,ab,kw OR 'postpartum bleeding':ti,ab,kw OR 'postpartum haemorrhage':ti,ab,kw OR 'puerperal haemorrhage':ti,ab,kw OR 'puerperal hemmorrhagia ':ti,ab,kw OR (('blood loss' NEAR/6 (postpartum OR 'post partum' OR delivery OR cesarean)):ti,ab,kw) OR 'obstetric* bleeding':ti,ab,kw OR 'obstetric* hemmorrhagia ':ti,ab,kw OR 'obstetric* haemorrhage':ti,ab,kw |
24932 |
|
#2 |
'intrauterine balloon'/exp/mj OR 'balloon tamponade'/exp OR ((balloon NEAR/3 (tamponade* OR intrauterine OR uterine OR bakri)):ti,ab,kw) |
2135 |
|
#3 |
#1 AND #2 AND [1990-2024]/py NOT (('animal'/exp OR 'animal experiment'/exp OR 'animal model'/exp OR 'nonhuman'/exp) NOT 'human'/exp) NOT ('conference abstract'/it OR 'conference review'/it OR 'editorial'/it OR 'letter'/it OR 'note'/it) |
411 |
|
#4 |
'meta analysis'/exp OR 'meta analysis (topic)'/exp OR metaanaly*:ti,ab OR 'meta analy*':ti,ab OR metanaly*:ti,ab OR 'systematic review'/de OR 'cochrane database of systematic reviews'/jt OR prisma:ti,ab OR prospero:ti,ab OR (((systemati* OR scoping OR umbrella OR 'structured literature') NEAR/3 (review* OR overview*)):ti,ab) OR ((systemic* NEAR/1 review*):ti,ab) OR (((systemati* OR literature OR database* OR 'data base*') NEAR/10 search*):ti,ab) OR (((structured OR comprehensive* OR systemic*) NEAR/3 search*):ti,ab) OR (((literature NEAR/3 review*):ti,ab) AND (search*:ti,ab OR database*:ti,ab OR 'data base*':ti,ab)) OR (('data extraction':ti,ab OR 'data source*':ti,ab) AND 'study selection':ti,ab) OR ('search strategy':ti,ab AND 'selection criteria':ti,ab) OR ('data source*':ti,ab AND 'data synthesis':ti,ab) OR medline:ab OR pubmed:ab OR embase:ab OR cochrane:ab OR (((critical OR rapid) NEAR/2 (review* OR overview* OR synthes*)):ti) OR ((((critical* OR rapid*) NEAR/3 (review* OR overview* OR synthes*)):ab) AND (search*:ab OR database*:ab OR 'data base*':ab)) OR metasynthes*:ti,ab OR 'meta synthes*':ti,ab |
997335 |
|
#5 |
'clinical trial'/exp OR 'randomization'/exp OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'crossover procedure'/exp OR 'placebo'/exp OR 'prospective study'/exp OR rct:ab,ti OR random*:ab,ti OR 'single blind':ab,ti OR 'randomised controlled trial':ab,ti OR 'randomized controlled trial'/exp OR placebo*:ab,ti |
3913335 |
|
#6 |
'case control study'/de OR 'comparative study'/exp OR 'control group'/de OR 'controlled study'/de OR 'controlled clinical trial'/de OR 'crossover procedure'/de OR 'double blind procedure'/de OR 'phase 2 clinical trial'/de OR 'phase 3 clinical trial'/de OR 'phase 4 clinical trial'/de OR 'pretest posttest design'/de OR 'pretest posttest control group design'/de OR 'quasi experimental study'/de OR 'single blind procedure'/de OR 'triple blind procedure'/de OR (((control OR controlled) NEAR/6 trial):ti,ab,kw) OR (((control OR controlled) NEAR/6 (study OR studies)):ti,ab,kw) OR (((control OR controlled) NEAR/1 active):ti,ab,kw) OR 'open label*':ti,ab,kw OR (((double OR two OR three OR multi OR trial) NEAR/1 (arm OR arms)):ti,ab,kw) OR ((allocat* NEAR/10 (arm OR arms)):ti,ab,kw) OR placebo*:ti,ab,kw OR 'sham-control*':ti,ab,kw OR (((single OR double OR triple OR assessor) NEAR/1 (blind* OR masked)):ti,ab,kw) OR nonrandom*:ti,ab,kw OR 'non-random*':ti,ab,kw OR 'quasi-experiment*':ti,ab,kw OR crossover:ti,ab,kw OR 'cross over':ti,ab,kw OR 'parallel group*':ti,ab,kw OR 'factorial trial':ti,ab,kw OR ((phase NEAR/5 (study OR trial)):ti,ab,kw) OR ((case* NEAR/6 (matched OR control*)):ti,ab,kw) OR ((match* NEAR/6 (pair OR pairs OR cohort* OR control* OR group* OR healthy OR age OR sex OR gender OR patient* OR subject* OR participant*)):ti,ab,kw) OR ((propensity NEAR/6 (scor* OR match*)):ti,ab,kw) OR versus:ti OR vs:ti OR compar*:ti OR ((compar* NEAR/1 study):ti,ab,kw) OR (('major clinical study'/de OR 'clinical study'/de OR 'cohort analysis'/de OR 'observational study'/de OR 'cross-sectional study'/de OR 'multicenter study'/de OR 'correlational study'/de OR 'follow up'/de OR cohort*:ti,ab,kw OR 'follow up':ti,ab,kw OR followup:ti,ab,kw OR longitudinal*:ti,ab,kw OR prospective*:ti,ab,kw OR retrospective*:ti,ab,kw OR observational*:ti,ab,kw OR 'cross sectional*':ti,ab,kw OR cross?ectional*:ti,ab,kw OR multicent*:ti,ab,kw OR 'multi-cent*':ti,ab,kw OR consecutive*:ti,ab,kw) AND (group:ti,ab,kw OR groups:ti,ab,kw OR subgroup*:ti,ab,kw OR versus:ti,ab,kw OR vs:ti,ab,kw OR compar*:ti,ab,kw OR 'odds ratio*':ab OR 'relative odds':ab OR 'risk ratio*':ab OR 'relative risk*':ab OR 'rate ratio':ab OR aor:ab OR arr:ab OR rrr:ab OR ((('or' OR 'rr') NEAR/6 ci):ab))) |
14572057 |
|
#7 |
#3 AND #4 - SR’s |
26 |
|
#8 |
#3 AND #5 NOT #7 - RCT’s |
72 |
|
#9 |
#3 AND #6 NOT #7 NOT #8 - Observationele studies |
124 |
|
#10 |
#7 OR #8 OR #9 |
122 |
Ovid/Medline
|
# |
Searches |
Results |
|
1 |
exp Postpartum Hemmorrhagia / or 'fluxus postpartum'.ti,ab,kf. or 'postpartum hemmorrhagia '.ti,ab,kf. or 'post partum haemorrhage'.ti,ab,kf. or 'post partum hemmorrhagia '.ti,ab,kf. or 'postpartal haemorrhage'.ti,ab,kf. or 'postpartal hemmorrhagia '.ti,ab,kf. or 'postpartum bleeding'.ti,ab,kf. or 'postpartum haemorrhage'.ti,ab,kf. or 'puerperal haemorrhage'.ti,ab,kf. or 'puerperal hemmorrhagia '.ti,ab,kf. or ('blood loss' adj6 (postpartum or 'post partum' or delivery or cesarean)).ti,ab,kf. or 'obstetric* bleeding'.ti,ab,kf. or 'obstetric* hemmorrhagia '.ti,ab,kf. or 'obstetric* haemorrhage'.ti,ab,kf |
14260 |
|
2 |
(exp Uterine Balloon Tamponade/ or (balloon adj3 (tamponade* OR intrauterine OR uterine OR bakri)).ti,ab,kf |
1293 |
|
3 |
1 and 2 |
466 |
|
4 |
limit 3 to yr="1990 -Current" |
465 |
|
5 |
4 not (comment/ or editorial/ or letter/ or ((exp animals/ or exp models, animal/) not humans/)) |
386 |
|
6 |
meta-analysis/ or meta-analysis as topic/ or (metaanaly* or meta-analy* or metanaly*).ti,ab,kf. or systematic review/ or cochrane.jw. or (prisma or prospero).ti,ab,kf. or ((systemati* or scoping or umbrella or "structured literature") adj3 (review* or overview*)).ti,ab,kf. or (systemic* adj1 review*).ti,ab,kf. or ((systemati* or literature or database* or data-base*) adj10 search*).ti,ab,kf. or ((structured or comprehensive* or systemic*) adj3 search*).ti,ab,kf. or ((literature adj3 review*) and (search* or database* or data-base*)).ti,ab,kf. or (("data extraction" or "data source*") and "study selection").ti,ab,kf. or ("search strategy" and "selection criteria").ti,ab,kf. or ("data source*" and "data synthesis").ti,ab,kf. or (medline or pubmed or embase or cochrane).ab. or ((critical or rapid) adj2 (review* or overview* or synthes*)).ti. or (((critical* or rapid*) adj3 (review* or overview* or synthes*)) and (search* or database* or data-base*)).ab. or (metasynthes* or meta-synthes*).ti,ab,kf. |
706165 |
|
7 |
exp clinical trial/ or randomized controlled trial/ or exp clinical trials as topic/ or randomized controlled trials as topic/ or Random Allocation/ or Double-Blind Method/ or Single-Blind Method/ or (clinical trial, phase i or clinical trial, phase ii or clinical trial, phase iii or clinical trial, phase iv or controlled clinical trial or randomized controlled trial or multicenter study or clinical trial).pt. or random*.ti,ab. or (clinic* adj trial*).tw. or ((singl* or doubl* or treb* or tripl*) adj (blind$3 or mask$3)).tw. or Placebos/ or placebo*.tw |
2654886 |
|
8 |
Case-control Studies/ or clinical trial, phase ii/ or clinical trial, phase iii/ or clinical trial, phase iv/ or comparative study/ or control groups/ or controlled before-after studies/ or controlled clinical trial/ or double-blind method/ or historically controlled study/ or matched-pair analysis/ or single-blind method/ or (((control or controlled) adj6 (study or studies or trial)) or (compar* adj (study or studies)) or ((control or controlled) adj1 active) or "open label*" or ((double or two or three or multi or trial) adj (arm or arms)) or (allocat* adj10 (arm or arms)) or placebo* or "sham-control*" or ((single or double or triple or assessor) adj1 (blind* or masked)) or nonrandom* or "non-random*" or "quasi-experiment*" or "parallel group*" or "factorial trial" or "pretest posttest" or (phase adj5 (study or trial)) or (case* adj6 (matched or control*)) or (match* adj6 (pair or pairs or cohort* or control* or group* or healthy or age or sex or gender or patient* or subject* or participant*)) or (propensity adj6 (scor* or match*))).ti,ab,kf. or (confounding adj6 adjust*).ti,ab. or (versus or vs or compar*).ti. or ((exp cohort studies/ or epidemiologic studies/ or multicenter study/ or observational study/ or seroepidemiologic studies/ or (cohort* or 'follow up' or followup or longitudinal* or prospective* or retrospective* or observational* or multicent* or 'multi-cent*' or consecutive*).ti,ab,kf.) and ((group or groups or subgroup* or versus or vs or compar*).ti,ab,kf. or ('odds ratio*' or 'relative odds' or 'risk ratio*' or 'relative risk*' or aor or arr or rrr).ab. or (("OR" or "RR") adj6 CI).ab.)) |
5553463 |
|
9 |
5 and 6 -SR’s |
25 |
|
10 |
(5 and 7) not 9 - RCT’s |
47 |
|
11 |
(5 and 8) not 9 not 10 - Observationele studies |
102 |
|
12 |
9 or 10 or 11 |
174 |
Embase 29-01-2024
|
No. |
Query |
Results |
|
#1 |
'postpartum hemmorrhagia '/exp OR 'fluxus postpartum':ti,ab,kw OR 'postpartum hemmorrhagia ':ti,ab,kw OR 'post partum haemorrhage':ti,ab,kw OR 'post partum hemmorrhagia ':ti,ab,kw OR 'postpartal haemorrhage':ti,ab,kw OR 'postpartal hemmorrhagia ':ti,ab,kw OR 'postpartum bleeding':ti,ab,kw OR 'postpartum haemorrhage':ti,ab,kw OR 'puerperal haemorrhage':ti,ab,kw OR 'puerperal hemmorrhagia ':ti,ab,kw OR (('blood loss' NEAR/6 (postpartum OR 'post partum' OR delivery OR cesarean)):ti,ab,kw) OR 'obstetric* bleeding':ti,ab,kw OR 'obstetric* hemmorrhagia ':ti,ab,kw OR 'obstetric* haemorrhage':ti,ab,kw |
25340 |
|
#2 |
('intrauterine balloon'/exp/mj OR 'balloon tamponade'/exp OR ((balloon NEAR/3 (tamponade* OR intrauterine OR uterine OR bakri OR occlus*)):ti,ab,kw)) AND ('artificial embolization'/exp OR embolizat*:ti,ab,kw OR embolisat*:ti,ab,kw OR embolotherap*:ti,ab,kw OR (((artificial OR therapeutic) NEAR/3 (thrombus OR occlusion)):ti,ab,kw)) |
1872 |
|
#3 |
#1 AND #2 AND [1990-2024]/py NOT (('animal'/exp OR 'animal experiment'/exp OR 'animal model'/exp OR 'nonhuman'/exp) NOT 'human'/exp) NOT ('conference abstract'/it OR 'conference review'/it OR 'editorial'/it OR 'letter'/it OR 'note'/it) |
162 |
|
#4 |
'meta analysis'/exp OR 'meta analysis (topic)'/exp OR metaanaly*:ti,ab OR 'meta analy*':ti,ab OR metanaly*:ti,ab OR 'systematic review'/de OR 'cochrane database of systematic reviews'/jt OR prisma:ti,ab OR prospero:ti,ab OR (((systemati* OR scoping OR umbrella OR 'structured literature') NEAR/3 (review* OR overview*)):ti,ab) OR ((systemic* NEAR/1 review*):ti,ab) OR (((systemati* OR literature OR database* OR 'data base*') NEAR/10 search*):ti,ab) OR (((structured OR comprehensive* OR systemic*) NEAR/3 search*):ti,ab) OR (((literature NEAR/3 review*):ti,ab) AND (search*:ti,ab OR database*:ti,ab OR 'data base*':ti,ab)) OR (('data extraction':ti,ab OR 'data source*':ti,ab) AND 'study selection':ti,ab) OR ('search strategy':ti,ab AND 'selection criteria':ti,ab) OR ('data source*':ti,ab AND 'data synthesis':ti,ab) OR medline:ab OR pubmed:ab OR embase:ab OR cochrane:ab OR (((critical OR rapid) NEAR/2 (review* OR overview* OR synthes*)):ti) OR ((((critical* OR rapid*) NEAR/3 (review* OR overview* OR synthes*)):ab) AND (search*:ab OR database*:ab OR 'data base*':ab)) OR metasynthes*:ti,ab OR 'meta synthes*':ti,ab |
997664 |
|
#5 |
'clinical trial'/exp OR 'randomization'/exp OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'crossover procedure'/exp OR 'placebo'/exp OR 'prospective study'/exp OR rct:ab,ti OR random*:ab,ti OR 'single blind':ab,ti OR 'randomised controlled trial':ab,ti OR 'randomized controlled trial'/exp OR placebo*:ab,ti |
3960541 |
|
#6 |
'case control study'/de OR 'comparative study'/exp OR 'control group'/de OR 'controlled study'/de OR 'controlled clinical trial'/de OR 'crossover procedure'/de OR 'double blind procedure'/de OR 'phase 2 clinical trial'/de OR 'phase 3 clinical trial'/de OR 'phase 4 clinical trial'/de OR 'pretest posttest design'/de OR 'pretest posttest control group design'/de OR 'quasi experimental study'/de OR 'single blind procedure'/de OR 'triple blind procedure'/de OR (((control OR controlled) NEAR/6 trial):ti,ab,kw) OR (((control OR controlled) NEAR/6 (study OR studies)):ti,ab,kw) OR (((control OR controlled) NEAR/1 active):ti,ab,kw) OR 'open label*':ti,ab,kw OR (((double OR two OR three OR multi OR trial) NEAR/1 (arm OR arms)):ti,ab,kw) OR ((allocat* NEAR/10 (arm OR arms)):ti,ab,kw) OR placebo*:ti,ab,kw OR 'sham-control*':ti,ab,kw OR (((single OR double OR triple OR assessor) NEAR/1 (blind* OR masked)):ti,ab,kw) OR nonrandom*:ti,ab,kw OR 'non-random*':ti,ab,kw OR 'quasi-experiment*':ti,ab,kw OR crossover:ti,ab,kw OR 'cross over':ti,ab,kw OR 'parallel group*':ti,ab,kw OR 'factorial trial':ti,ab,kw OR ((phase NEAR/5 (study OR trial)):ti,ab,kw) OR ((case* NEAR/6 (matched OR control*)):ti,ab,kw) OR ((match* NEAR/6 (pair OR pairs OR cohort* OR control* OR group* OR healthy OR age OR sex OR gender OR patient* OR subject* OR participant*)):ti,ab,kw) OR ((propensity NEAR/6 (scor* OR match*)):ti,ab,kw) OR versus:ti OR vs:ti OR compar*:ti OR ((compar* NEAR/1 study):ti,ab,kw) OR (('major clinical study'/de OR 'clinical study'/de OR 'cohort analysis'/de OR 'observational study'/de OR 'cross-sectional study'/de OR 'multicenter study'/de OR 'correlational study'/de OR 'follow up'/de OR cohort*:ti,ab,kw OR 'follow up':ti,ab,kw OR followup:ti,ab,kw OR longitudinal*:ti,ab,kw OR prospective*:ti,ab,kw OR retrospective*:ti,ab,kw OR observational*:ti,ab,kw OR 'cross sectional*':ti,ab,kw OR cross?ectional*:ti,ab,kw OR multicent*:ti,ab,kw OR 'multi-cent*':ti,ab,kw OR consecutive*:ti,ab,kw) AND (group:ti,ab,kw OR groups:ti,ab,kw OR subgroup*:ti,ab,kw OR versus:ti,ab,kw OR vs:ti,ab,kw OR compar*:ti,ab,kw OR 'odds ratio*':ab OR 'relative odds':ab OR 'risk ratio*':ab OR 'relative risk*':ab OR 'rate ratio':ab OR aor:ab OR arr:ab OR rrr:ab OR ((('or' OR 'rr') NEAR/6 ci):ab))) |
14780951 |
|
#7 |
'major clinical study'/de OR 'clinical study'/de OR 'case control study'/de OR 'family study'/de OR 'longitudinal study'/de OR 'retrospective study'/de OR 'prospective study'/de OR 'comparative study'/de OR 'cohort analysis'/de OR ((cohort NEAR/1 (study OR studies)):ab,ti) OR (('case control' NEAR/1 (study OR studies)):ab,ti) OR (('follow up' NEAR/1 (study OR studies)):ab,ti) OR (observational NEAR/1 (study OR studies)) OR ((epidemiologic NEAR/1 (study OR studies)):ab,ti) OR (('cross sectional' NEAR/1 (study OR studies)):ab,ti) |
8047431 |
|
#8 |
#3 AND #4 - SR |
12 |
|
#9 |
#3 AND #5 NOT #8 - RCT |
17 |
|
#10 |
#3 AND (#6 OR #7) NOT (#8 OR #9) - observationeel |
73 |
|
#11 |
#8 OR #9 OR #10 |
102 |
Ovid/Medline
|
# |
Searches |
Results |
|
1 |
exp Postpartum Hemmorrhagia / or 'fluxus postpartum'.ti,ab,kf. or 'postpartum hemmorrhagia '.ti,ab,kf. or 'post partum haemorrhage'.ti,ab,kf. or 'post partum hemmorrhagia '.ti,ab,kf. or 'postpartal haemorrhage'.ti,ab,kf. or 'postpartal hemmorrhagia '.ti,ab,kf. or 'postpartum bleeding'.ti,ab,kf. or 'postpartum haemorrhage'.ti,ab,kf. or 'puerperal haemorrhage'.ti,ab,kf. or 'puerperal hemmorrhagia '.ti,ab,kf. or ('blood loss' adj6 (postpartum or 'post partum' or delivery or cesarean)).ti,ab,kf. or 'obstetric* bleeding'.ti,ab,kf. or 'obstetric* hemmorrhagia '.ti,ab,kf. or 'obstetric* haemorrhage'.ti,ab,kf. |
14478 |
|
2 |
(exp Uterine Balloon Tamponade/ or (balloon adj3 (tamponade* or intrauterine or uterine or bakri or occlus*)).ti,ab,kf.) and (exp Embolization, Therapeutic/ or embolizat*.ti,ab,kf. or embolisat*.ti,ab,kf. or embolotherap*.ti,ab,kf. or ((artificial or therapeutic) adj3 (thrombus or occlusion)).ti,ab,kf.) |
2809 |
|
3 |
1 and 2 |
486 |
|
4 |
3 not (comment/ or editorial/ or letter/ or ((exp animals/ or exp models, animal/) not humans/)) |
401 |
|
5 |
limit 4 to yr="1990 -Current" |
401 |
|
6 |
meta-analysis/ or meta-analysis as topic/ or (metaanaly* or meta-analy* or metanaly*).ti,ab,kf. or systematic review/ or cochrane.jw. or (prisma or prospero).ti,ab,kf. or ((systemati* or scoping or umbrella or "structured literature") adj3 (review* or overview*)).ti,ab,kf. or (systemic* adj1 review*).ti,ab,kf. or ((systemati* or literature or database* or data-base*) adj10 search*).ti,ab,kf. or ((structured or comprehensive* or systemic*) adj3 search*).ti,ab,kf. or ((literature adj3 review*) and (search* or database* or data-base*)).ti,ab,kf. or (("data extraction" or "data source*") and "study selection").ti,ab,kf. or ("search strategy" and "selection criteria").ti,ab,kf. or ("data source*" and "data synthesis").ti,ab,kf. or (medline or pubmed or embase or cochrane).ab. or ((critical or rapid) adj2 (review* or overview* or synthes*)).ti. or (((critical* or rapid*) adj3 (review* or overview* or synthes*)) and (search* or database* or data-base*)).ab. or (metasynthes* or meta-synthes*).ti,ab,kf. |
722378 |
|
7 |
exp clinical trial/ or randomized controlled trial/ or exp clinical trials as topic/ or randomized controlled trials as topic/ or Random Allocation/ or Double-Blind Method/ or Single-Blind Method/ or (clinical trial, phase i or clinical trial, phase ii or clinical trial, phase iii or clinical trial, phase iv or controlled clinical trial or randomized controlled trial or multicenter study or clinical trial).pt. or random*.ti,ab. or (clinic* adj trial*).tw. or ((singl* or doubl* or treb* or tripl*) adj (blind$3 or mask$3)).tw. or Placebos/ or placebo*.tw. |
2683558 |
|
8 |
Epidemiologic studies/ or case control studies/ or exp cohort studies/ or Controlled Before-After Studies/ or Case control.tw. or cohort.tw. or Cohort analy$.tw. or (Follow up adj (study or studies)).tw. or (observational adj (study or studies)).tw. or Longitudinal.tw. or Retrospective*.tw. or prospective*.tw. or consecutive*.tw. or Cross sectional.tw. or Cross-sectional studies/ or historically controlled study/ or interrupted time series analysis/ [Onder exp cohort studies vallen ook longitudinale, prospectieve en retrospectieve studies] |
4637250 |
|
9 |
Case-control Studies/ or clinical trial, phase ii/ or clinical trial, phase iii/ or clinical trial, phase iv/ or comparative study/ or control groups/ or controlled before-after studies/ or controlled clinical trial/ or double-blind method/ or historically controlled study/ or matched-pair analysis/ or single-blind method/ or (((control or controlled) adj6 (study or studies or trial)) or (compar* adj (study or studies)) or ((control or controlled) adj1 active) or "open label*" or ((double or two or three or multi or trial) adj (arm or arms)) or (allocat* adj10 (arm or arms)) or placebo* or "sham-control*" or ((single or double or triple or assessor) adj1 (blind* or masked)) or nonrandom* or "non-random*" or "quasi-experiment*" or "parallel group*" or "factorial trial" or "pretest posttest" or (phase adj5 (study or trial)) or (case* adj6 (matched or control*)) or (match* adj6 (pair or pairs or cohort* or control* or group* or healthy or age or sex or gender or patient* or subject* or participant*)) or (propensity adj6 (scor* or match*))).ti,ab,kf. or (confounding adj6 adjust*).ti,ab. or (versus or vs or compar*).ti. or ((exp cohort studies/ or epidemiologic studies/ or multicenter study/ or observational study/ or seroepidemiologic studies/ or (cohort* or 'follow up' or followup or longitudinal* or prospective* or retrospective* or observational* or multicent* or 'multi-cent*' or consecutive*).ti,ab,kf.) and ((group or groups or subgroup* or versus or vs or compar*).ti,ab,kf. or ('odds ratio*' or 'relative odds' or 'risk ratio*' or 'relative risk*' or aor or arr or rrr).ab. or (("OR" or "RR") adj6 CI).ab.)) |
5608359 |
|
10 |
5 and 6 - SR |
29 |
|
11 |
(5 and 7) not 10 - RCT |
49 |
|
12 |
(5 and (8 or 9)) not (10 or 11) - observationeel |
188 |
|
13 |
10 or 11 or 12 |
266 |