Echoscopie voorafgaand aan een vaginale kunstverlossing
Uitgangsvraag
Wat is de aanvullende waarde van echoscopisch onderzoek naar de foetale stand van het hoofd voorafgaand aan een vaginale kunstverlossing?
Aanbeveling
Vervaardig niet routinematig echoscopisch onderzoek naar de foetale stand van het hoofd voorafgaand aan een vacuümextractie met als doel de slagingskans te verhogen.
Overwegingen
De onderstaande overwegingen en aanbevelingen gelden voor het overgrote deel van de populatie waarop de uitgangsvraag betrekking heeft.
Voor- en nadelen van de interventie en de kwaliteit van het bewijs
Voor zover uit de tot op heden bestaande literatuur valt op te maken zijn er geen voordelen om vooraf aan een vaginale kunstverlossing, de stand van het hoofd nog middels echoscopisch onderzoek te controleren. Met name is er geen sprake van meer geslaagde vaginale kunstverlossing. Ook zijn er geen verschillen in maternale en neonatale morbiditeit als wel of niet tevoren echoscopisch onderzoek heeft plaatsgevonden. Het vervaardigen van echoscopisch onderzoek leidt wel tot een vertraging in het baringsproces en heeft derhalve wel nadelen.
Omdat echoscopisch onderzoek tijdens de baring nog relatief kort wordt toegepast, is het aantal studies over dit onderwerp nog te beperkt om definitieve conclusies te trekken. Het gebrek aan voldoende en grote studies maakt dat de bewijskracht van de aanbevelingen laag tot zeer laag is.
Waarden en voorkeuren van patiënten (en eventueel hun verzorgers)
Helaas is in geen van de gebruikte studies de uitkomstmaat patiënttevredenheid of voorkeur meegenomen.
Kosten (middelenbeslag)
Eventuele invoering van een echoscopisch onderzoek voorafgaand aan een vaginale kunstverlossing kan zonder veel toename van kosten plaatsvinden. Er dient anno 2021 op een verloskamercomplex altijd al een echoapparaat aanwezig te zijn.
Aanvaardbaarheid voor de overige relevante stakeholders
De aanbeveling zal niet leiden tot extra kosten of meer logistieke maatregelen.
Haalbaarheid en implementatie
De aanbeveling zal niet leiden tot aanpassing van het huidige beleid.
Rationale/ balans tussen de argumenten voor en tegen de interventie
Voor zover uit de tot op heden bestaande literatuur valt op te maken zijn er geen voordelen om vooraf aan een vaginale kunstverlossing, de stand van het hoofd nog middels echoscopisch onderzoek te controleren. Met name is er geen sprake van meer geslaagde vaginale kunstverlossing. Ook zijn er geen verschillen in maternale en neonatale morbiditeit als wel of niet tevoren echoscopisch onderzoek heeft plaatsgevonden. Een mogelijk nadeel is de vertraging in het baringsproces.
Onderbouwing
Achtergrond
Veelal wordt op basis van de bevindingen bij vaginaal toucher waarbij naast de hoogte van het caput ook de stand van het caput van belang is de keuze gemaakt om een vaginale kunstverlossing uit te voeren en mogelijk een voorkeur voor het type vacuüm bepaald. Soms kan het lastig zijn om de stand van een caput bij toucher vast te stellen door mate van moulage en caput succedaneum. Het uitvoeren van echoscopisch onderzoek is behulpzaam bij de bepaling van de stand van het caput bij twijfel hierover.
De kans op slagen van een vaginale kunstverlossing is onder andere afhankelijk van de juiste tractierichting bij een achterhoofd-achter of kruinligging. Het juist vaststellen van de stand van het caput is hierbij van belang. Echoscopisch onderzoek is een eenvoudig en betrouwbaar onderzoek om in geval van twijfel hierover zekerheid te bieden. Er lijkt veel praktijkvariatie te bestaan in het gebruik van echoscopisch onderzoek ter verificatie van de stand van het caput. Het is niet duidelijk of echoscopisch onderzoek daadwerkelijk ook tot andere keuzes voor kunstverlossing (vaginaal versus sectio) of tot een hoger percentage geslaagde vaginale kunstverlossingen leidt.
Conclusies
1. Mode of delivery
|
Very low GRADE |
The evidence is very uncertain about the effect of vaginal examination only or additional ultrasound examination on mode of delivery in women with term delivery and indication for instrumental vaginal delivery.
Bronnen: (Ghi, 2018; Dückelmann, 2012) |
2. Successful instrumental delivery
|
Low GRADE |
The evidence suggests that there is little to no difference in successful outcome of vacuum delivery between vaginal examination only or additional ultrasound examination in women with term delivery and indication for instrumental vaginal delivery.
Bronnen: (Ghi, 2018; Wong, 2007; Barak, 2018) |
3. Cup detachments
|
Very low GRADE |
The evidence is very uncertain about the effect on cup detachments between vaginal examination only or additional ultrasound examination in women with term delivery and indication for instrumental vaginal delivery.
Bronnen: (Ghi, 2018; Dückelmann, 2012) |
4. Maternal complication - Postpartum hemorrhage
|
Very low GRADE |
The evidence is very uncertain about the effect on postpartum hemorrhage between vaginal examination only or additional ultrasound examination in women with term delivery and indication for instrumental vaginal delivery.
Bronnen: (Ghi, 2018; Dückelmann, 2012) |
5. Analgesia
|
Very low GRADE |
The evidence is very uncertain about the effect on need for analgesia between vaginal examination only or additional ultrasound examination in women prolonged second stage of labor.
Bronnen: (Dückelmann, 2012) |
6. Maternal complications - perineal trauma
|
Low GRADE |
The evidence suggests that there is little to no difference in perineal trauma between vaginal examination only or additional ultrasound examination in women with term delivery and indication for instrumental vaginal delivery.
Bronnen: (Ghi, 2018; Popowski, 2015; Wong, 2007; Dückelmann, 2012) |
7. Neonatal mortality
|
Very low GRADE |
The evidence is very uncertain about the effect on neonatal mortality between vaginal examination only or additional ultrasound examination in women with prolonged second stage of labor.
Bronnen: (Barak, 2018) |
8. Neonatal complications - infection
|
Very low GRADE |
The evidence is very uncertain about the effect on neonatal infections between vaginal examination only or additional ultrasound examination in women with prolonged second stage of labor.
Bronnen: (Barak, 2018) |
9. Neonatal complications - Apgar score
|
Very low GRADE |
The evidence is very uncertain about the effect on 5 min Apgar score after vaginal examination only or additional ultrasound examination in women with indication for instrumental vaginal delivery.
Bronnen: (Ghi, 2018; Popowski, 2015; Wong, 2007) |
10. Neonatal complications - shoulder dystocia
|
Very low GRADE |
The evidence is very uncertain about the effect on shoulder dystocia between vaginal examination only or additional ultrasound examination in women with indication for instrumental vaginal delivery.
Bronnen: (Ghi, 2018; Barak, 2018) |
11. Neonatal complications - trauma caput
|
Very low GRADE |
The evidence is very uncertain about the effect on neonatal hematoma between vaginal examination only or additional ultrasound examination in women with indication for instrumental vaginal delivery.
Bronnen: (Ghi, 2018; Barak, 2018) |
12. Neonatal hospital/NICU admission
|
Very low GRADE |
The evidence is very uncertain about the effect on NICU admissions of neonates after term delivery between vaginal examination only or additional ultrasound examination in women with indication for instrumental vaginal delivery.
Bronnen: (Ghi, 2018, Popowski, 2015, Barak, 2018) |
Samenvatting literatuur
Description of studies
Of the five included studies, three are randomized controlled trials (Ghi, 2018; Popowski, 2015; Wong, 2007), and two are retrospective cohort studies (Barak, 2018; Dückelmann, 2012). Two studies included women with an indication for instrumental vaginal delivery (Ghi, 2018; Wong, 2007), two studies included women with prolonged second stage of labor (Barak, 2018; Dückelmann, 2012), and one study included women who received epidural anesthesia (Popowski, 2015).
The study of Ghi (2018) is a randomized controlled trial that included nulliparous women with term (37+0 to 41+6 weeks of gestation) singleton pregnancies that required instrumental vaginal delivery by vacuum extraction (n=222). Women were randomized to assessment of fetal head position before attempted instrumental delivery by either vaginal examination (VE) alone or VE plus transabdominal sonography (TAS). The study was stopped before the planned sample size (n=1310) was reached.
The study of Popowski (2015) is a pragmatic open-label randomized controlled trial that included women with singleton pregnancies in vertex presentation at ≥ 37 weeks’ gestation, cervical dilation ≥ 8 cm and who received epidural anesthesia (n=1903). Women were assigned randomly to undergo either digital vaginal examination (VE group) or both digital vaginal and ultrasound examinations (VE+US group) to determine fetal head position.
Maternal and neonatal outcomes were reported for the total study group, and separately for women who had an instrumental vaginal delivery (n=457), according to determination of fetal head position by VE or by VE+US.
The study of Wong (2007) is a randomized controlled trial that included women with an indication for vacuum extraction for prolonged second stage of labor (n=50). Women were randomly allocated to either digital examination or digital examination together with transabdominal intrapartum ultrasound prior to vacuum extraction. Primary outcome was accuracy of vacuum cup placement.
The study of Barak (2018) is a retrospective cohort study including women delivering at term with the diagnosis of protracted second stage of labor (n=635). The mode of delivery and rate of failed VE were compared between women who underwent a US examination prior to the decision on obstetrical interventions (“+US” group) and those in whom clinical decisions were based upon digital assessment only (“no-US” group).
The study of Dückelmann (2012) is a retrospective cohort study including women delivering at term diagnosed with a prolonged second stage of labor (n=121). Women who underwent intrapartal ultrasound prior to obstetrical intervention were compared with a group of women for whom the delivery modus was decided upon after clinical digital examination alone.
Results
1. Mode of delivery
Ghi (2018) reported vacuum extraction in 130/132 (98.5%), and cesarean section in 2/132 (1.5%) in the group vaginal examination only, and vacuum extraction in 89/89 (100%) in the group additional ultrasound examination.
Dückelmann (2012) reported no cesarean sections in the group additional ultrasound (0/43) and 3/78 cesarean sections in the group vaginal examination only.
Level of evidence of the literature
The level of evidence regarding the outcome measure mode of delivery was downgraded by 3 levels because of study limitations (risk of bias), and number of included patients (imprecision, only one study) to ‘very low’.
2. Successful vacuum extraction
Ghi (2018) reported vacuum extraction in 130/132 (98.5%) in the group vaginal examination only, and 89/89 (100%) in the group additional ultrasound examination.
Wong (2007) reported failed vacuum extraction in 1/25 in the group vaginal examination only, and no cases of failed vacuum extraction in the group additional ultrasound examination (0/25).
Barak (2018) defined failed vacuum extraction as any of the following: no descent of the fetal head with each pull of the cup, after three cup detachments\pop-ups, or if delivery did not occur within 20 minutes. Failed vacuum attempts in the group additional ultrasound examination were 0/99 (0%), and 13/536 (3.6%) in the group vaginal examination only (p=0.1).
Level of evidence of the literature
The level of evidence regarding the outcome measure successful vacuum extraction was downgraded by 2 levels because of study limitations (risk of bias) and number of included patients (imprecision) to ’low’.
3. Cup detachments
Ghi (2012) reported no difference in median (range) number of cup detachments between the intervention group (median 0, range: 0 to 2) and the control group (median 0, range: 0 to 3, p=0.16).
Dückelmann (2012) reported 1/43 cup detachments in the group additional ultrasound examination and 2/78 in the group vaginal examination only.
Level of evidence of the literature
The level of evidence regarding the outcome measure cup detachments was downgraded by 3 levels because of study limitations (risk of bias); number of included patients (imprecision) to ‘very low’.
4. Maternal mortality
No cases of maternal mortality were reported in any of the studies.
5. Maternal complications- postpartum hemorrhage
Ghi (2018) reported the outcome postpartum hemorrhage in 14.6% (13/89) in the group that received additional ultrasound examination, and in 13.6% (18/132) in the group vaginal examination only (p=0.85).
Dückelmann (2012) reported that when adjusted for the mode of delivery, there was no significant difference in blood loss between the groups (data not reported).
Level of evidence of the literature
The level of evidence regarding the outcome measure postpartum hemorrhage was downgraded by 3 levels because of study limitations (risk of bias) and number of included patients (imprecision) to ‘very low’.
6. Maternal complications - analgesia
Dückelmann (2012) reported in the group additional ultrasound examination 79.1% (34/43) of the women receiving epidural analgesia, and 83.3% (65/78) in the group vaginal examination only.
Level of evidence of the literature
The level of evidence regarding the outcome measure analgesia started low (observational study design) and was downgraded by 2 levels because of study limitations (risk of bias); applicability (bias due to indirectness); number of included patients (imprecision) to ‘very low’.
7. Maternal complications - perineal trauma
Four studies reported the outcome measure third- or fourth-degree perineal lacerations (Ghi, 2018; Popowski, 2015; Wong, 2007; Dückelmann, 2012).
Ghi (2018) reported third- or fourth-degree perineal lacerations in 5/89 (5.6%) in the group receiving additional ultrasound examination, and 7/132 (5.3%) in the group vaginal examination only (p=1.00).
Popowski (2015) reported third- or fourth-degree perineal lacerations in 4/244 (1.6%) in the group receiving additional ultrasound examination, and 2/213 (0.9%) in the group vaginal examination only (p=0.42).
Wong (2007) reported no third- or fourth-degree perineal lacerations in both groups.
Dückelmann (2012) reported third-degree perineal laceration 1/43 (2.3%) in the group receiving additional ultrasound and 3/78 (3.8%) in the group vaginal examination only.
Level of evidence of the literature
The level of evidence regarding the outcome measure perineal trauma was downgraded by 2 levels because of study limitations (risk of bias) and number of included patients (imprecision) to `low’.
8. Neonatal mortality
The outcome neonatal death was reported in one study (Barak, 2018). Barak (2018) reported no cases of neonatal death in the group additional ultrasound examination (0/99) and two cases in the group VE only (2/536).
Level of evidence of the literature
The level of evidence regarding the outcome measure neonatal mortality started low (cohort study) and was downgraded by 2 levels because of applicability (bias due to indirectness); number of included patients (imprecision, only one study) to ‘very low’.
9. Neonatal complications - infections
Barak (2018) reported the outcome measure neonatal sepsis. In the group receiving additional ultrasound examination sepsis was reported in 0/99 (0%) neonates and in the group vaginal examination only in 3/536 (0.6%).
Level of evidence of the literature
The level of evidence regarding the outcome measure neonatal complication sepsis started low (observational study) and was downgraded by 3 levels because of study limitations (risk of bias); applicability (bias due to indirectness); and number of included patients (imprecision, only one study) to ‘very low’.
10. Neonatal complications - 5 min Apgar score < 7
The outcome measure 5 min Apgar score < 7 was reported in three studies (Ghi, 2018; Popowski, 2015; Wong, 2007).
Ghi (2018) reported a 5-min Apgar score < 7 in 1 neonate (1.1%) in the group receiving additional ultrasound examination, and 2 neonates (1.5%) in the group vaginal examination only (p=0.81).
Popowski (2015) reported, in the subgroup instrumental vaginal delivery, a 5-min Apgar score < 7 in 5 cases (2.0%) in the group receiving additional ultrasound examination and 3 cases (1.4%) in the group vaginal examination only (p=0.73).
Wong (2007) reported in their study that ‘all babies were born with a good Apgar score’ (no data reported).
Level of evidence of the literature
The level of evidence regarding the outcome measure 5 min Apgar score < 7 was downgraded by 3 levels because of study limitations (risk of bias); number of included patients (imprecision) to ‘very low’.
11. Neonatal complications - shoulder dystocia
Ghi (2018) reported the outcome measure shoulder dystocia. In the group additional ultrasound examination 4/89 (4.5%), and in the group vaginal examination only 2/132 (1.5%) (p=0.22).
Barak (2018) reported Erbs palsy 0/99 in the group receiving additional ultrasound examination, and 3/536 in the group vaginal examination only.
Level of evidence of the literature
The level of evidence regarding the outcome measure shoulder dystocia was downgraded by 3 levels because of study limitations (risk of bias) and number of included patients (imprecision) to ‘very low’
12. Neonatal complications - trauma caput
Ghi (2018) reported cephalohematoma in 2/89 (2.2%) in the group receiving additional ultrasound examination, and 5/132 (3.8%) in the group vaginal examination only (p=0.70).
Barak (2018) reported subgaleal hematoma 0/99 in the group receiving additional ultrasound examination, and 7/536 in the group vaginal examination only.
Level of evidence of the literature
The level of evidence regarding the outcome measure trauma was downgraded by 3 levels because of study limitations (risk of bias) and number of included patients (imprecision) to ‘very low’.
13. Neonatal hospital/NICU admission
NICU admission was reported in three studies (Ghi, 2018, Popowski, 2015; Barak, 2018).
Ghi (2018) reported NICU admission in 5/89 (5.6%) in the group additional ultrasound examination and 9/132 (6.8%) in the group vaginal examination only (p=0.72).
Popowski (2015) reported, in the subgroup instrumental vaginal delivery, transfer to NICU in 1/244 (0.4%) in the group receiving additional ultrasound examination, and 2/213 (0.9%) in the group vaginal examination only (p=0.60).
Barak (2018) reported NICU admission in 1/99 (1.0%) in the group receiving additional ultrasound examination, and 14/536 (2.6%) in the group vaginal examination only.
Level of evidence of the literature
The level of evidence regarding the outcome measure hospital/NICU admission was downgraded by 3 levels because of study limitations (risk of bias); number of included patients and wide confidence intervals (imprecision) to ‘very low’.
14. Patient satisfaction
The outcome ‘patient satisfaction’ was not reported in any of the studies.
15. Breastfeeding
The outcome ‘breastfeeding’ was not reported in any of the studies.
16. Mother child bonding
The outcome ‘bonding’ was not reported in any of the studies.
For the outcomes measures maternal mortality, patient satisfaction, breastfeeding and mother child bonding the level of evidence (GRADE) has not been determined due to lack of studies reporting these outcomes.
Zoeken en selecteren
A systematic review of the literature was performed to answer the following question:
What is the additional value of ultrasound examination compared to vaginal examination of the foetal head position alone preceding vaginal delivery by vacuum extraction?
P: patients women in labour (term delivery), indication assisted instrumental vaginal delivery (vacuum);
I: intervention ultrasound examination foetal head position caput;
C: control digital vaginal examination foetal head position;
O: outcome measure Maternal: successful vacuum extraction, maternal mortality, cup replacement, maternal complications (postpartum blood loss, perineal trauma), patient satisfaction, breastfeeding, and maternal bonding.
Neonatal: neonatal mortality, neonatal complications (infection, Apgar score < 7 after 5 minutes, hospital/Neonatal Intensive Care Unit (NICU) admission.
Relevant outcome measures
The guideline development group considered successful vacuum extraction and mortality as critical outcome measures for decision making; and morbidity, complications, hospital/NICU admission, patient satisfaction, breastfeeding, and bonding as important outcome measures for decision making.
A priori, the working group did not define the outcome measures listed above but used the definitions used in the studies.
The working group defined 5% as a minimal clinically (patient) important difference for the outcome measure successful vacuum extraction. For other outcome measures the working group defined the GRADE-default- a difference of 25% in the relative risk for dichotomous outcomes (Schünemann, 2013) and 0.5 standard deviation for continuous outcomes - as a 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 until May 6th 2019. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 241 hits. Studies were selected based on the following criteria:
- study design systematic review, RCT, or cohort;
- published between 1st of January 2001 and 6th of May 2019;
- meeting the PICO criteria;
- included one of the above described outcome measures.
32 studies were initially selected based on title and abstract screening. After reading the full text, 27 studies were excluded (see the table with reasons for exclusion under the tab Methods) and 5 studies were included.
Results
Five 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
- Barak, O., Levy, R., Flidel, O., Zaks, S., Gillor, M., Hagay, Z. & Vaisbuch, E. (2018). The Routine Use of Intrapartum Ultrasound in Clinical Decision-Making during the Second Stage of Labor-Does It Have Any Impact on Delivery Outcomes? Gynecologic and Obstetric Investigation, 83(1), 9-14.
- Dückelmann, A. M., Michaelis, S. A., Bamberg, C., Dudenhausen, J. W. & Kalache, K. D. (2012). Impact of intrapartal ultrasound to assess fetal head position and station on the type of obstetrical interventions at full cervical dilatation. Journal of Maternal-Fetal & Neonatal Medicine, 25(5), 484-488.
- Ghi, T., Dall'Asta, A., Masturzo, B., Tassis, B., Martinelli, M., Volpe, N., Prefumo, F., Rizzo, G., Pilu, G., Cariello, L., Sabbioni, L., Morselli-Labate, A. M., Todros, T. & Frusca, T. (2018). Randomised Italian Sonography for occiput POSition Trial Ante vacuum (R.I.S.POS.T.A.). Ultrasound in Obstetrics & Gynecology, 52(6), 699-705.
- Popowski, T., Porcher, R., Fort, J., Javoise, S. & Rozenberg, P. (2015). Influence of ultrasound determination of fetal head position on mode of delivery: a pragmatic randomized trial. Ultrasound in obstetrics & gynecology: the official journal of the International Society of Ultrasound in Obstetrics and Gynecology, 46(5), 520-525.
- Wong, G. Y., Mok, Y. M. & Wong, S. F. (2007). Transabdominal ultrasound assessment of the fetal head and the accuracy of vacuum cup application. International Journal of Gynecology and Obstetrics, 98(2), 120-123.
Evidence tabellen
Evidence table for intervention studies (randomized controlled trials and non-randomized observational studies (cohort studies, case-control studies, case series))
|
Study reference |
Study characteristics |
Patient characteristics 2 |
Intervention (I) |
Comparison / control (C) 3
|
Follow-up |
Outcome measures and effect size 4 |
Comments |
|
Ghi, 2018 |
Type of study: RCT
Setting and country: multicentre (maternity hospitals) Italy
Funding and conflicts of interest: not reported |
Inclusion criteria: nulliparous women >18 years with term (37+0 to 41+6 weeks of gestation) singleton pregnancy that required instrumental vaginal delivery by vacuum extraction
Exclusion criteria: age<18 or>50 yrs, contraindication to instrumental vaginal delivery by vacuum extraction, fetal head station >+3 cm, emergency delivery necessary due to intrapartum fetal distress, sonographic evaluation of fetal head position performed before randomization
N total at baseline: 222 Intervention: 90 Control:132
Important prognostic factors:
Maternal age (years) All: 32.5(6.3) VE: 33.2 (5.8) VE+TAS: 32.1 (6.1)
Groups comparable at baseline? a significantly higher incidence of non-OA fetal head position at randomization (15.7% versus 3.0%, P <0.01) in the intervention group, higher incidence of incorrect diagnosis of occiput position in the control group (17/132 (12.9%) versus 4/89 (4.5%), P =0.04)
|
Describe intervention (treatment/procedure/test):
fetal occiput position was assessed by VE followed by TAS, before application of the vacuum cup; classified into occiput anterior (OA) (left and right) and non-OA position, which included occiput posterior (left and right) and transverse (left and right) position
|
Describe control (treatment/procedure/test):
fetal head position (and station) were determined only by means of vaginal examination (VE) before vacuum extraction |
Length of follow-up: 24 hours after delivery
Loss-to-follow-up: none
Incomplete outcome data: Intervention: 1 (1%) Reasons: physician decided not to perform vacuum extraction; eventually caesarean section Control: 0 (0%)
|
Outcome measures and effect size (include 95%CI and p-value if available):
emergency Cesarean delivery: I: 0/89. C: 2/132. p=0.24
median (range) number of cup detachments: I: 0 (0-2). C: 0 (0-3). p=0.16
Mode of delivery Vacuum 130 (98.5) 89 (100)
Cesarean section 2 (1.5) 0 (0)
Number of cup detachments 0 (0–3) 0 (0–2) 0.16
Episiotomy 94 (71.2) 77 (86.5) 0.009
Third- or fourth-degree perineal tear 7 (5.3) 5 (5.6) 1.00
Postpartum hemorrhage 18 (13.6) 13 (14.6) 0.85
5-min Apgar score <7 2 (1.5) 1 (1.1) 0.81
neonatal acidosis (umbilical artery pH<7.00 or base excess < −12 mEq/L),
UA pH 7.23 (6.70–7.40) 7.25 (7.05–7.40) 0.74
UA pH<7.00 2 (1.5) 1 (1.1) 0.81
UA base excess > −12 mEq/L 15 (11.4) 8 (9.0) 0.57
Cephalohematoma 5 (3.8) 2 (2.2) 0.70
NICU admission 9 (6.8) 5 (5.6) 0.72
Shoulder dystocia 2 (1.5) 4 (4.5) P=0.22 |
trial stopped early because of recruitment problems (planned sample size 1400)
a significantly higher incidence of non-OA fetal head position at randomization (15.7% versus 3.0%, P <0.01) in the intervention group, a higher incidence of incorrect diagnosis of occiput position in the control group (17/132 (12.9%) versus 4/89 (4.5%), P=0.04) |
|
Popowski, 2015 |
Type of study: RCT, open-label
Setting and country: University hospital, France
Funding and conflicts of interest: not reported |
Inclusion criteria: >=18 years old, -entered labor with a singleton fetus in the vertex presentation at ≥37 weeks of gestation, with cervical dilation ≥8 cm, -received epidural anesthesia -provided written informed consent.
Exclusion criteria: -previous Cesarean delivery, -pre-eclampsia, -placenta previa or other obstetric disorder, -participation in another trial -refusal to sign the informed consent
N total at baseline: N=1903 Intervention: 944 Control: 959
Important prognostic factors2:
Maternal age (years, range) I: 30 (27–33) C: 30 (27–34)
Groups comparable at baseline?
|
Describe intervention (treatment/procedure/test):
Digital vaginal examination followed by a systematic ultrasound verification examination (VE+US group)
Ultrasonography was performed by a midwife or physician within 15 min after the vaginal examination.
A portable Voluson-i ultrasound machine (GE Medical Systems, V´elizy, France) with a 3.5-MHz transducer was used to perform the ultrasound examinations.
A two-step procedure was used for ultrasound determination in the VE+US group. The position of the fetal spine was determined, at the level of the fetal heart and in relation to the maternal abdomen. The position of the fetal occiput was restricted to within 90◦ clockwise or counterclockwise of the spine position. The ultrasound transducer followed the spine downwards and was then placed on the pubic symphysis to obtain a transverse view relative to the maternal anatomy. An attempt was made to identify the fetal cranial contour, cranial midline, and fetal orbits or superciliary arch in the same plane. When identified, other anatomical features (nose, cheeks, ears, thalami, cavum septi pellucidi) also assisted in determining the fetal position.
|
Describe control (treatment/procedure/test):
Digital vaginal examination only (VE group)
All digital vaginal examinations were performed by the midwife responsible for the follow-up after rupture of the membranes during the first stage of labor and were not performed during a uterine contraction
|
Length of follow-up: Not reported
Loss-to-follow-up: - Incomplete outcome data: -
|
Outcome measures and effect size (include 95%CI and p-value if available):
Neonatal outcomes
5-min Apgar score <7 VE: 12 (1.3) VE + US : 9 (1.0) RR: 0.76 (0.32–1.80) P=0.66
Maternal outcomes
Third- or fourth-degree perineal lacerations VE: 10 (1.0) VE+US: 7 (0.7) RR: 0.71 (0.27–1.86) P=0.63
Outcome VE (n=959) VE+US (n=944) RR (95% CI) P
Operative delivery 260 (27.1) 318 (33.7) 1.24 (1.08–1.43) 0.002
Cesarean delivery 47 (4.9) 74 (7.8) 1.60 (1.12–2.28) 0.01
Fetal distress 16 (34.0) 34 (45.9)
Failure to progress from 8 cm to full cervical dilatation 8 (17.0) 17 (23.0)
Failure to progress in second stage of labor 23 (48.9) 23 (31.1)
Instrumental vaginal delivery 213 (22.2) 244 (25.8) 1.16 (0.99–1.37) 0.07
Fetal distress 113 (53.1) 121 (49.6)
Failure to progress 100 (46.9) 123 (50.4)
Episiotomy 296 (30.9) 334 (35.4) 1.15 (1.01–1.30) 0.04
Postpartum hemorrhage 81 (8.4) 92 (9.8) 1.16 (0.87–1.54) 0.34
First- or second-degree perineal lacerations 426 (44.4) 388 (41.1) 0.93 (0.83–1.03) 0.15
Third- or fourth-degree perineal lacerations 10 (1.0) 7 (0.7) 0.71 (0.27–1.86) 0.63
Intrapartum fever 44 (4.6) 60 (6.4) 1.39 (0.95–2.02) 0.11
1-min Apgar score <7 101 (10.5) 105 (11.1) 1.06 (0.82–1.37) 0.71
5-min Apgar score <7 12 (1.3) 9 (1.0) 0.76 (0.32–1.80) 0.66
Umbilical cord pH<7.2 100 (10.4) 117 (12.4) 1.19 (0.92–1.53) 0.19
Meconium aspiration syndrome 2 (0.2) 2 (0.2) 1.02 (0.07–14.0) 1.00
Transfer to NICU 6 (0.6) 4 (0.4) 0.68 (0.14–2.86) 0.75
Neonatal trauma 8 (0.8) 16 (1.7) 2.04 (0.88–4.73) 0.10
Maternal and neonatal outcomes in 457 women who had an instrumental vaginal delivery, according to determination of fetal head position by digital vaginal examination (VE) only or by VE and subsequent ultrasound examination (VE+US)
Outcome VE (n=213) VE+US (n=244) P
Episiotomy 166 (77.9) 147 (60.2) 0.84
First- or second-degree perineal lacerations 84 (39.4) 66 (27.1) 0.48
Third- or fourth-degree perineal lacerations 2 (0.9) 4 (1.6) 0.42
1-min Apgar score <7 39 (18.3) 37 (15.2) 0.38
5-min Apgar score <7 3 (1.4) 5 (2.0) 0.73
Umbilical cord pH<7.2 39 (18.3) 39 (16.0) 0.80
Meconium aspiration syndrome 0 (0) 1 (0.4) 1
Transfer to NICU 2 (0.9) 1 (0.4) 0.60
Neonatal trauma 5 (2.3) 13 (5.3) 0.15 |
The prespecified primary outcome was operative delivery, including Cesarean delivery after cervical dilation ≥8 cm and instrumental vaginal delivery.
Prespecified secondary outcomes were (i) delivery criteria (separate Cesarean and instrumental vaginal delivery rates); (ii) maternal morbidity (postpartum hemorrhage, episiotomy, perineal lacerations or intrapartum fever); and (iii) neonatal morbidity (1-min and 5-min Apgar scores <7, umbilical cord pH<7.20, meconium aspiration syndrome, neonatal trauma or transfer to NICU). |
|
Wong, 2007 |
Type of study: RCT
Setting and country: Single-center, Hong-Kong
Funding and conflicts of interest: not reported |
Inclusion criteria: Women who were fully dilated with cephalic-presenting fetuses with ruptured membranes and an indication for vacuum extraction were recruited.
Exclusion criteria: -multiple pregnancy, -preterm labor (less than 37 weeks), -fetal distress or suspected fetal distress, -high fetal head position, -clinical suspicion of gross cephalo-pelvic disproportion -other contraindications for vacuum extraction
N total at baseline: N=50 Intervention: n=25 Control: n=25
Important prognostic factors2: Age (years) I: 30.4 (5.2) C: 29.3 (3.3) P=0.316
Parity n(%) Primiparous I: N=11 (44) C: N=6 (24)
Gestational age (weeks) I: 39.7 C: 39.9 P= 0.793
Groups comparable at baseline? Yes |
Describe intervention (treatment/procedure/test):
immediately after abdominal and transvaginal digital examination of the fetal head were performed, the fetal head position was also assessed using transabdominal ultrasound by the same operator, using an ultrasound machine (Aloka 650, Tokyo, Japan).
The operators were residents with 3 to 4 years of obstetric training.
The fetal head position was determined by ultrasound using the fetal orbital region, the fetal cervical spine to locate the head. The fetal orbital region, the fetal cervical spine, the cerebral midline, and the cerebellum were used to determine the head position. The ultrasound transducer was placed longitudinally, tangentially to the skin and was used to look for the cervical fetal spine and occipital bone. The ultrasound transducer was then placed transversely in the suprapubic region of the maternal abdomen and the fetal head position was confirmed using the position of the midline cerebral echo and that of the cerebellum.
|
Describe control (treatment/procedure/test):
abdominal and transvaginal digital examination of the fetal head |
Length of follow-up: The outcome of the babies 1 to 3 days post-delivery
Loss-to-follow-up: - Incomplete outcome data: -
|
Outcome measures and effect size (include 95%CI and p-value if available):
Failed vacuum extraction US:n=0/25 NO-US: n=1/25 (fetal head position was in DOA with 2+ caput and 3+ moulding, and the vertex was at station +1 level. There was a slipped cup during the third pull, and the baby was delivered using forceps delivery after one pull)
third degree perineal tear: US: n=0 No-Us: n=0
Neonatal outcomes
“all babies were born with a good apgar score” no data reported
|
accuracy of the vacuum cup placement primary outcome: Comparison of the distance between the center of the chignon and the flexion point between the Ultrasound Group and the No Ultrasound Group |
|
Barak, 2018 |
Type of study: Cohort, retrospective
Setting and country: Single-center, Israel
Funding and conflicts of interest: ‘The authors report no declarations of interest.’ |
Inclusion criteria: All women delivering at term (37–42 weeks gestation), at least one of the following diagnoses was recorded in the electronic chart during the second stage of labor: (1) prolonged second stage, (2) arrest of descent, (3) suspected cephalopelvic disproportion (CPD), and (4) failed VE.
Exclusion criteria: Women with a multiple gestation, a non-vertex presentation, delivery prior to 37 + 0/7 weeks or beyond 42 + 0/7, or with a diagnosis of a non-reassuring fetal heart rate (NRFHR) monitoring were excluded from the study.
N total at baseline: 635 Intervention: n=99 Control: n=536
Important prognostic factors2: “+US” group (n = 99) “no-US” group (n = 536) p value
Maternal age, years 28.8±5.4 28.35±4.8 0.5
Gestational age at delivery, weeks 40.1±1.3 39.9±1.3 0.8
Nulliparity 77.6 (416) 78.8 (78) 0.8
Groups comparable at baseline? |
Describe intervention (treatment/procedure/test):
Women had, in addition to a vaginal examination, an intrapartum US prior to the decision on obstetrical intervention during the second stage of labor (“+US” group).
|
Describe control (treatment/procedure/test):
only vaginal examination was used (“no-US” group) for clinical decision-making. |
Length of follow-up:
Loss-to-follow-up: Intervention: N (%) Reasons (describe)
Control: N (%) Reasons (describe)
Incomplete outcome data: Intervention: N (%) Reasons (describe)
Control: N (%) Reasons (describe)
|
Outcome measures and effect size (include 95%CI and p-value if available):
Failed vacuum attempts “no-US” 13 (3.6%) “+US” group’0 (0%) p = 0.1
Adverse neonatal Outcomes
“no-US” group (n = 536)
“+US” group (n = 99) p value
Total 33/536 3/99 0.3
Major Respiratory assistance 10/536 0/99
Hospitalization to NICU 14/536 1/99
Subgaleal hematoma 7/536 0/99
Erb’s palsy 3/536 0/99
Neonatal sepsis 3/536 0/99
Neonatal death 2/536 0/99 |
a failed VE is defined when any of the following conditions are met: no descent of the fetal head with each pull of the cup, after 3 cup detachments\pop-ups, or if delivery did not occur within 20 min.
‘Beginning from 2011, some attending physicians in our Labor and Delivery ward incorporated intrapartum US in their routine management of non-progressive labors’
|
|
Duckelmann, 2012 |
Type of study: Cohort, retrospective
Setting and country: University hospital, Germany
Funding and conflicts of interest: |
Inclusion criteria: -women who had a live, cephalic, singleton pregnancy at term in a 1-year period -diagnosed with a prolonged second stage of labor
Exclusion criteria:
N total at baseline: N=121 Intervention: 43/121 (36%) Control: 78/121 (64%)
Important prognostic factors2: No ultrasound p value
Gestational age, week 40 (5) 40 (5)
Duration of second stage, min 159 ± 60 177 ± 52 ns
Blood loss, ml 460 ± 480 391 ± 177
Maternal age 29 ± 5 28 ± 5
Umbilical artery pH 7.26 ± 0.06 7.28 ± 0.06
Groups comparable at baseline? Yes (+ no significant differences in fetal position between the two groups).
|
Describe intervention (treatment/procedure/test):
in Group A, the managing obstetrician used transperineal ultrasound to evaluate fetal head descent;
|
Describe control (treatment/procedure/test):
in Group B, transperineal ultrasound was not used. |
Length of follow-up:
Loss-to-follow-up: Intervention: N (%) Reasons (describe)
Control: N (%) Reasons (describe)
Incomplete outcome data: Intervention: N (%) Reasons (describe)
Control: N (%) Reasons (describe)
|
Outcome measures and effect size (include 95%CI and p-value if available):
In Group A, 79.07% of women received an epidural analgesia (34 out of 43 patients), as did 83.33% in Group B (65 out of 78).
When we adjusted for the mode of delivery, there was no significant difference in blood loss between Groups A and B. (data not reported)
Among women with active-phase arrest
In Group B, one relaparatomy was necessary because of bleeding and maternal circulatory collapse after cesarean section. One cesarean section was necessary in Group B after attempted vacuum extraction failed; another two patients underwent cesarean section after the vacuum cup detached.
In Group A, the vacuum cup detached in one case; however, the result was a spontaneous delivery. Vacuum extraction in Group A was described as straightforward in all other patients, and there were no complications.
Laceration One woman in Group B had a laceration of the cervix and three women had a third-degree perineal laceration (III b), whereas in
Group A there was only one woman with a third-degree perineal laceration.
One woman had postpartum atony and another woman had placental retention in Group B. In one woman in Group A, who already had a cesarean section, the operation revealed a perforation of the uterus, which was treated at that time. |
the diagnosis of active-phase arrest was defined as no fetal head descent within one hour in nulliparous (2 h in multiparous) deliveries after the beginning of the second stage of labor in the presence of adequate uterine contractions. This time could be prolonged by 1 h if analgesia was given.
The choice to use or not use perineal ultrasound was left to the individual obstetrician |
Risk of bias table for intervention studies (randomized controlled trials)
|
Study reference
(first author, publication year) |
Describe method of randomisation1 |
Bias due to inadequate concealment of allocation?2
(unlikely/likely/unclear) |
Bias due to inadequate blinding of participants to treatment allocation?3
(unlikely/likely/unclear) |
Bias due to inadequate blinding of care providers to treatment allocation?3
(unlikely/likely/unclear) |
Bias due to inadequate blinding of outcome assessors to treatment allocation?3
(unlikely/likely/unclear) |
Bias due to selective outcome reporting on basis of the results?4
(unlikely/likely/unclear) |
Bias due to loss to follow-up?5
(unlikely/likely/unclear) |
Bias due to violation of intention to treat analysis?6
(unlikely/likely/unclear) |
|
Ghi, 2018 |
‘dedicated online program’
|
unclear ‘Allocation concealment was guaranteed as in all cases the physician performing the instrumental delivery was not responsible for the randomization process.’
|
blinding not possible |
blinding not possible |
blinding not possible |
unlikely |
unlikely |
likely |
|
Popowski, 2015 |
‘Eligible women were assigned randomly in the labor room to one of two groups, at a 1:1 ratio. Allocation to one of the two groups was performed by the distribution of opaque envelopes, each containing one allocation. The random allocation sequences were generated with a computer random-number generator by the study statistician, according to a permuted block method.’ |
unlikely |
likely, open-label |
likely, open-label |
likely, open-label |
unlikely |
unlikely |
unlikely |
|
Wong, 2007 |
‘Randomization was done by computer-generated random numbers in a ratio of 1:1 using sealed envelopes, which were opened after recruitment, at the time of decision for vacuum extraction.’ |
unlikely |
Blinding not possible |
Blinding not possible |
unclear |
unclear |
unlikely |
unlikely |
Risk of bias table for intervention studies (observational: non-randomized clinical trials, cohort and case-control studies)
|
Study reference
(first author, year of publication) |
Bias due to a non-representative or ill-defined sample of patients?1
(unlikely/likely/unclear) |
Bias due to insufficiently long, or incomplete follow-up, or differences in follow-up between treatment groups?2
(unlikely/likely/unclear) |
Bias due to ill-defined or inadequately measured outcome ?3
(unlikely/likely/unclear) |
Bias due to inadequate adjustment for all important prognostic factors?4
(unlikely/likely/unclear) |
|
Barak, 2018 |
unlikely |
unlikely |
unlikely |
lilkely |
|
Duckelman, 2012 |
likely |
unlikely |
unlilely |
likely |
Table of excluded studies
|
Author and year |
Reason for exclusion |
|
Usman 2019 |
Does not meet PICO criteria, wrong comparison |
|
Chan 2019 |
Predictive value Angle of Progression |
|
Ali 2019 |
Does not meet PICO criteria, wrong comparison |
|
Pizzicaroli 2018 |
Spinal versus epidural analgesia |
|
Desurmont 2018 |
Cutoff level fetal head-perineum distance |
|
Sainz 2017 |
Trans perineal ultrasound to predict cases of failure in vacuum extraction |
|
Kasbaoui 2017 |
Predicting the difficulty of operative vaginal delivery by ultrasound measurement of fetal head station |
|
Kahrs 2017 |
Prediction ultrasound outcome of vacuum deliveries |
|
Sainz 2016 |
Trans perineal ultrasound to predict cases of failure in vacuum extraction |
|
Gilboa 2016 |
Predictive value ultrasound success rates of operative vaginal delivery |
|
Antonio Sainz 2016 |
Trans perineal ultrasound to predict cases of failure in vacuum extraction |
|
Sainz 2015 |
Does not meet PICO criteria, wrong comparison |
|
Udayasankar 2007 |
Does not meet PICO criteria |
|
Bellussi 2017 |
Does not meet PICO criteria, not comparative research |
|
Bultez 2016 |
Prediction failed vacuum |
|
Malvasi 2015 |
Narrative review |
|
Morin 2011 |
Does not meet PICO criteria, wrong population and comparison |
|
Garçia-Mejido 2018 |
Avulsion m.levator ani |
|
Bibbo 2018 |
Association between the AoP and mode of delivery and duration |
|
Phipps 2015 |
Association sonographically determined occipito-transverse position and operative delivery |
|
Ooi 2015 |
Predictive value fetal head circumference of operative delivery |
|
Cuerva 2014 |
Ultrasound in the prediction of complicated operative forceps delivery |
|
Sainz 2018 |
Does not meet PICO criteria |
|
Phipps 2014 |
Does not meet PICO criteria, association occipito-transverse position and operative delivery |
|
Mejido 2014 |
Transabdominal ultrasound vacuum cup application |
|
Ghi 2013 |
Predictive value ultrasound |
|
Kalache 2009 |
Predictive value Angle of Progression |
Verantwoording
Autorisatiedatum en geldigheid
Laatst beoordeeld : 23-01-2023
Laatst geautoriseerd : 23-01-2023
Geplande herbeoordeling :
Geldigheid en Onderhoud
|
Module |
Regiehouder(s) |
Jaar van autorisatie |
Eerstvolgende beoordeling actualiteit richtlijn |
Frequentie van beoordeling op actualiteit |
Wie houdt er toezicht op actualiteit |
Relevante factoren voor wijzigingen in aanbeveling |
|
Echoscopie voorafgaand aan een vaginale kunstverlossing |
NVOG |
2021 |
2026 |
Elke 5 jaar |
NVOG |
Nieuwe literatuur |
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 uit 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 2019 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 zwangeren.
Werkgroep
- Dr. C.J. (Caroline) Bax, gynaecoloog-perinatoloog, werkzaam in het Amsterdam UMC locatie AMC, NVOG, voorzitter stuurgroep
- Dr. A.C.C. (Annemiek) Evers, gynaecoloog, werkzaam in het Universitair Medisch Centrum Utrecht, NVOG, voorzitter stuurgroep tot 2019
- Dr. S.V. (Steven) Koenen, gynaecoloog, werkzaam in het ETZ, locatie Elisabeth Ziekenhuis, NVOG, lid stuurgroep
- Dr. J.J. (Hans) Duvekot, gynaecoloog, werkzaam in het Erasmus MC, NVOG, lid stuurgroep
- Dr. M.T.M. (Maureen) Franssen, gynaecoloog-perinatoloog, werkzaam in het Universitair Medisch Centrum Groningen, NVOG
- Dr. I.P.M. (Ingrid) Gaugler-Senden, gynaecoloog, werkzaam in het Jeroen Bosch Ziekenhuis, NVOG
- M.A. (Marleen) van Driel, gastdocent en gezondheidsvoorlichter, Stichting Zelfbewustzwanger
- J.C. (Anne) Mooij, MSc, adviseur, Patientenfederatie Nederland
- A.M. (Sandra) Oomen van Dun, MSc, Physician assistant/klinisch verloskunde, werkzaam in het Elisabeth TweeSteden Ziekenhuis te Tilburg, KNOV
- H. (Hannah) de Klerk, MSc, zelfstandig waarnemend verloskundige, KNOV
- D.C. (Lianne) Zondag, MSc, beleidsmedewerker en eerstelijns verloskundige, KNOV
Meelezers
• Leden van de Otterlo-werkgroep (2019-2021)
Met ondersteuning van
• Dr. L. (Laura) Viester, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
• Dr. J.H. (Hanneke) van der Lee, senior-adviseur, Kennisinstituut van de Federatie Medisch Specialisten
Belangenverklaringen
De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Alle werkgroepleden hebben schriftelijk verklaard of zij in de laatste drie jaar directe financiële belangen (betrekking bij een commercieel bedrijf, persoonlijke financiële belangen, onderzoeksfinanciering) of indirecte belangen (persoonlijke relaties, reputatiemanagement) hebben gehad. Gedurende de ontwikkeling of herziening van een module worden wijzigingen in belangen aan de voorzitter doorgegeven. De belangenverklaring wordt opnieuw bevestigd tijdens de commentaarfase.
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.
|
Werkgroeplid |
Functie |
Nevenwerkzaamheden |
Gemelde belangen |
Actie |
|
Bax * (voorzitter stuurgroep 2020) |
Gynaecoloog-perinatoloog Amsterdam UMC 0,8 fte |
Allen niet betaald: Seceretaris werkgroep Otterlo NVOG Lid commissie kwaliteitsdocumenten NVOG Voorzitter stuurgroep 50 modules project geboortezorg NVOG Penningmeester werkgroep infectieziekten NVOG Lid kernteam NIPS consortium Vrijwillger hospice Xenia |
Geen |
Geen actie |
|
Evers * (voorzitter stuurgroep tot 2019) |
Gynaecoloog, UMCU |
"Lid van Ciekwal, voorzitter 50 geboortemodules NVOG Werkgroep multidisciplinaire richtlijn extreme vroeggeboorte, NVOG" |
Geen |
Geen actie |
|
Duvekot (lid stuurgroep) |
Gynaecoloog, Erasmus MC (full time) |
Directeur 'medisch advies en expertise bureau Duvekot', Ridderkerk, ZZP'er |
Geen |
Geen actie |
|
Koenen (lid stuurgroep) |
gynaecoloog, ETZ , Tilburg |
incidenteel juridische expertise (betaald) |
Geen |
Geen actie |
|
Gaugler-Senden |
Gynaecoloog, vrijgevestigd 0,8fte geen |
Geen |
Geen |
Geen actie |
|
Franssen |
Gynaecoloog-Perinatoloog UMCG |
Niet van toepassing |
Geen |
Geen actie |
|
Van Driel |
Gastdocent en gezondheidsvoorlichter, freelance |
Voorlichting geven op middelbaar onderwijs en MBO betreffende seksualiteit, bloed/stamcel/orgaan donatie en beroepsgerichte verdieping op de MBO kraam opleiding. |
Geen |
Geen actie |
|
De Klerk |
Zelfstandig waarnemend verloskundige, 1fte |
PhD-student Vumc afdeling Midwifery Science, onbetaald |
Geen |
Geen actie |
|
Oomen-van Dun |
Physician assistant/klinisch verloskunde Elisabeth TweeSteden Ziekenhuis te Tilburg, 0,83fte |
Niet van toepassing |
Geen |
Geen actie. |
|
Mooij |
adviseur Patientenbelang, Patientenfederatie Nederland |
Niet van toepassing |
Geen |
Geen actie |
|
Zondag |
Beleidsmedewerker KNOV - 0,5fte Eerstelijns verloskundige – medepraktijk eigenaar verloskundige praktijk De Toekomst Geldermalsen 0,8fte |
Begeleider literatuurstudies en MSc thesis bij MSc Klinische Verloskunde aan de Hogeschool Rotterdam (betaald) Bestuurslid Netwerk Rivierenland (onbetaald) |
Geen |
Geen actie |
Inbreng patiëntenperspectief
Er werd aandacht besteed aan het patiëntenperspectief door vertegenwoordigers van de Patiëntenfederatie Nederland, Stichting Zelfbewustzwanger af te vaardigen in de werkgroep.
Implementatie
Implementatieplan
|
Aanbeveling |
Tijdspad voor implementatie: < 1 jaar, 1 tot 3 jaar of > 3 jaar |
Verwacht effect op kosten |
Randvoorwaarden voor implementatie (binnen aangegeven tijdspad) |
Mogelijke barrières voor implementatie |
Te ondernemen acties voor implementatie |
Verantwoordelijken voor acties |
Overige opmerkingen |
|
1e |
< 1 jaar |
Geen |
Tijdig publiceren op richtlijnendatabase |
Geen, is conform het reeds geldende beleid |
Publicatie in de richtlijnendatabase |
NVOG |
|
Werkwijze
AGREE
Deze richtlijnmodule is opgesteld conform de eisen vermeld in het rapport Medisch Specialistische Richtlijnen 2.0 van de adviescommissie Richtlijnen van de Raad Kwaliteit. Dit rapport is gebaseerd op het AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II; Brouwers, 2010).
Knelpuntenanalyse en uitgangsvragen
Tijdens de voorbereidende fase inventariseerden de werkgroep de knelpunten in de geboortezorg. Tevens zijn er knelpunten aangedragen middels een invitational conference in november 2018. Een verslag hiervan is opgenomen onder aanverwante producten. Tijdens de voorbereidende fase inventariseerden de voorzitter van de werkgroep en de adviseur de knelpunten. Tevens is er een knelpunteninventarisatie gedaan in november 2018 middels een invitational conference.
Op basis van de uitkomsten van de knelpuntenanalyse zijn door de werkgroep concept-uitgangsvragen opgesteld en definitief vastgesteld.
Uitkomstmaten
Na het opstellen van de zoekvraag behorende bij de uitgangsvraag inventariseerde de werkgroep welke uitkomstmaten voor de patiënt relevant zijn, waarbij zowel naar gewenste als ongewenste effecten werd gekeken. Hierbij werd een maximum van acht uitkomstmaten gehanteerd. De werkgroep waardeerde deze uitkomstmaten volgens hun relatieve belang bij de besluitvorming rondom aanbevelingen, als cruciaal (kritiek voor de besluitvorming), belangrijk (maar niet cruciaal) en onbelangrijk. Tevens definieerde de werkgroep tenminste voor de cruciale uitkomstmaten welke verschillen zij klinisch (patiënt) relevant vonden.
Methode literatuursamenvatting
Een uitgebreide beschrijving van de strategie voor zoeken en selecteren van literatuur en de beoordeling van de risk-of-bias van de individuele studies is te vinden onder ‘Zoeken en selecteren’ onder Onderbouwing. De beoordeling van de kracht van het wetenschappelijke bewijs wordt hieronder toegelicht.
Beoordelen van de kracht van het wetenschappelijke bewijs
De kracht van het wetenschappelijke bewijs werd bepaald volgens de GRADE-methode. GRADE staat voor ‘Grading Recommendations Assessment, Development and Evaluation’ (zie http://www.gradeworkinggroup.org/). De basisprincipes van de GRADE-methodiek zijn: het benoemen en prioriteren van de klinisch (patiënt) relevante uitkomstmaten, een systematische review per uitkomstmaat, en een beoordeling van de bewijskracht per uitkomstmaat op basis van de acht GRADE-domeinen (domeinen voor downgraden: risk of bias, inconsistentie, indirectheid, imprecisie, en publicatiebias; domeinen voor upgraden: dosis-effect relatie, groot effect, en residuele plausibele confounding).
GRADE onderscheidt vier gradaties voor de kwaliteit van het wetenschappelijk bewijs: hoog, redelijk, laag en zeer laag. Deze gradaties verwijzen naar de mate van zekerheid die er bestaat over de literatuurconclusie, in het bijzonder de mate van zekerheid dat de literatuurconclusie de aanbeveling adequaat ondersteunt (Schünemann, 2013; Hultcrantz, 2017).
|
Definitie |
|
|
Hoog |
|
|
Redelijk |
|
|
Laag |
|
|
Zeer laag |
|
Bij het beoordelen (graderen) van de kracht van het wetenschappelijk bewijs in richtlijnen volgens de GRADE-methodiek spelen grenzen voor klinische besluitvorming een belangrijke rol (Hultcrantz, 2017). Dit zijn de grenzen die bij overschrijding aanleiding zouden geven tot een aanpassing van de aanbeveling. Om de grenzen voor klinische besluitvorming te bepalen moeten alle relevante uitkomstmaten en overwegingen worden meegewogen. De grenzen voor klinische besluitvorming zijn daarmee niet één op één vergelijkbaar met het minimaal klinisch relevant verschil (Minimal Clinically Important Difference, MCID). Met name in situaties waarin een interventie geen belangrijke nadelen heeft en de kosten relatief laag zijn, kan de grens voor klinische besluitvorming met betrekking tot de effectiviteit van de interventie bij een lagere waarde (dichter bij het nuleffect) liggen dan de MCID (Hultcrantz, 2017).
Overwegingen (van bewijs naar aanbeveling)
Om te komen tot een aanbeveling zijn naast (de kwaliteit van) het wetenschappelijke bewijs ook andere aspecten belangrijk en worden meegewogen, zoals aanvullende argumenten uit bijvoorbeeld de biomechanica of fysiologie, waarden en voorkeuren van patiënten, kosten (middelenbeslag), aanvaardbaarheid, haalbaarheid en implementatie. Deze aspecten zijn systematisch vermeld en beoordeeld (gewogen) onder het kopje ‘Overwegingen’ en kunnen (mede) gebaseerd zijn op expert opinion. Hierbij is gebruik gemaakt van een gestructureerd format gebaseerd op het evidence-to-decision framework van de internationale GRADE Working Group (Alonso-Coello, 2016a; Alonso-Coello, 2016b). Dit evidence-to-decision framework is een integraal onderdeel van de GRADE methodiek.
De aanbevelingen geven antwoord op de uitgangsvraag en zijn gebaseerd op het beschikbare wetenschappelijke bewijs en de belangrijkste overwegingen, en een weging van de gunstige en ongunstige effecten van de relevante interventies. De kracht van het wetenschappelijk bewijs en het gewicht dat door de werkgroep wordt toegekend aan de overwegingen, bepalen samen de sterkte van de aanbeveling. Conform de GRADE-methodiek sluit een lage bewijskracht van conclusies in de systematische literatuuranalyse een sterke aanbeveling niet a priori uit, en zijn bij een hoge bewijskracht ook zwakke aanbevelingen mogelijk (Agoritsas, 2017; Neumann, 2016). De sterkte van de aanbeveling wordt altijd bepaald door weging van alle relevante argumenten tezamen. De werkgroep heeft bij elke aanbeveling opgenomen hoe zij tot de richting en sterkte van de aanbeveling zijn gekomen.
In de GRADE-methodiek wordt onderscheid gemaakt tussen sterke en zwakke (of conditionele) aanbevelingen. De sterkte van een aanbeveling verwijst naar de mate van zekerheid dat de voordelen van de interventie opwegen tegen de nadelen (of vice versa), gezien over het hele spectrum van patiënten waarvoor de aanbeveling is bedoeld. De sterkte van een aanbeveling heeft duidelijke implicaties voor patiënten, behandelaars en beleidsmakers (zie onderstaande tabel). Een aanbeveling is geen dictaat, zelfs een sterke aanbeveling gebaseerd op bewijs van hoge kwaliteit (GRADE gradering HOOG) zal niet altijd van toepassing zijn, onder alle mogelijke omstandigheden en voor elke individuele patiënt.
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Implicaties van sterke en zwakke aanbevelingen voor verschillende richtlijngebruikers |
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Sterke aanbeveling |
Zwakke (conditionele) aanbeveling |
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Voor patiënten |
De meeste patiënten zouden de aanbevolen interventie of aanpak kiezen en slechts een klein aantal niet. |
Een aanzienlijk deel van de patiënten zouden de aanbevolen interventie of aanpak kiezen, maar veel patiënten ook niet. |
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Voor behandelaars |
De meeste patiënten zouden de aanbevolen interventie of aanpak moeten ontvangen. |
Er zijn meerdere geschikte interventies of aanpakken. De patiënt moet worden ondersteund bij de keuze voor de interventie of aanpak die het beste aansluit bij zijn of haar waarden en voorkeuren. |
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Voor beleidsmakers |
De aanbevolen interventie of aanpak kan worden gezien als standaardbeleid. |
Beleidsbepaling vereist uitvoerige discussie met betrokkenheid van veel stakeholders. Er is een grotere kans op lokale beleidsverschillen. |
Organisatie van zorg
In de knelpuntenanalyse en bij de ontwikkeling van de richtlijnmodule is expliciet aandacht geweest voor de organisatie van zorg: alle aspecten die randvoorwaardelijk zijn voor het verlenen van zorg (zoals coördinatie, communicatie, (financiële) middelen, mankracht en infrastructuur). Randvoorwaarden die relevant zijn voor het beantwoorden van deze specifieke uitgangsvraag zijn genoemd bij de overwegingen.
Commentaar- en autorisatiefase
De conceptrichtlijnmodule werd aan de betrokken (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd ter commentaar. De commentaren werden verzameld en besproken met de werkgroep. Naar aanleiding van de commentaren werd de conceptrichtlijnmodule aangepast en definitief vastgesteld door de werkgroep. De definitieve richtlijnmodule werd aan de deelnemende (wetenschappelijke) verenigingen en (patiënt) organisaties voorgelegd voor autorisatie en door hen geautoriseerd dan wel geaccordeerd.
Zoekverantwoording
Zoekacties zijn opvraagbaar. Neem hiervoor contact op met de Richtlijnendatabase.