Rupture of membranes
Uitgangsvraag
Moet een amniotomie worden verricht of verdient een afwachtend beleid de voorkeur tijdens de actieve fase van de bevalling bij nulliparae à terme met een niet-vorderende ontsluiting?
Clinical question
Should the membranes be ruptured at all or is expectant management preferable in the active stage of labour in nulliparous women at term with arrested or protracted labour?
Aanbeveling
Amniotomie kan worden overwogen bij nulliparae à terme (≥ 37/0 weken) met een foetus in hoofdligging, wanneer er sprake is van een niet-vorderende ontsluiting en na geïnformeerde toestemming van de barende.
Recommendation
Amniotomy alone may be considered when there is arrested or protracted labour in nulliparous women at term (≥ 37/0 weeks) and with a fetus in cephalic presentation following a positive consent of the mother.
Overwegingen
Considerations – evidence to decision
Pros and cons of the intervention and quality of the evidence
The results of the literature analysis are inconclusive for the key outcomes, and it is therefore not possible to conclude from the literature whether amniotomy is or is not an effective intervention for arrested or protracted labour. The potential pros of amniotomy are that it may speed up labour without adverse perinatal consequences, is useful if a fetal electrode need to be placed, and there is evidence the intervention is favoured by labouring women. The disadvantages are that it may be an ineffective intervention, it may cause umbilical cord prolapse, and that an increased chance of maternal or perinatal infection cannot be excluded.
De resultaten van de literatuuranalyse zijn niet eenduidig voor de belangrijkste uitkomstmaten. Op basis van de beschikbare literatuur kan daarom niet worden geconcludeerd of amniotomie een effectieve interventie is bij niet-vorderende ontsluiting. Potentiële voordelen van amniotomie zijn dat het de bevalling mogelijk kan versnellen zonder nadelige perinatale gevolgen, dat het nuttig kan zijn bij de plaatsing van een foetale elektrode, dat de kleur van het vruchtwater kan worden beoordeeld en dat er aanwijzingen zijn dat barende vrouwen deze interventie verkiezen boven andere interventies. De nadelen zijn dat amniotomie mogelijk ineffectief is, het risico op een navelstrengprolaps en dat een verhoogde kans op maternale of perinatale infectie niet kan worden uitgesloten.
Values and preferences of patients (and their caregivers)
There appears to be maternal preference in favour of amniotomy. Individual clinical interpretation of these factors, supported be an informed discussion with parent(s), is recommended.
Er lijkt sprake te zijn van een voorkeur voor amniotomie bij barende vrouwen. Het is aanbevolen om een individuele klinische afweging te maken van de mogelijke voor- en nadelen, ondersteund door een geïnformeerd gesprek met de ouder(s).
Costs
The cost of amniotomy is minimal and this is unlikely to be an important factor in determining its clinical role. If effective, this procedure may reduce the cost of additional interventions e.g. oxytocin infusion, epidural requests following a more prolonged course of labour, or avoidable cesarean delivery.
De kosten van een amniotomie zijn minimaal en zal waarschijnlijk geen doorslaggevende rol spelen bij de klinische besluitvorming over het al dan niet uitvoeren van deze ingreep. Indien effectief, kan amniotomie de kosten van aanvullende interventies verlagen, zoals een oxytocine infuus, epidurale analgesie bij een een langduriger bevallingstraject of een vermijdbare sectio caesarea.
Acceptability, feasibility and implementation
Amniotomy is a widely performed intervention and changing its current usage is likely to be challenging without good evidence either in favour or against its usage, despite its inconclusive effect when used alone
Amniotomie is een veelgebruikte interventie en het aanpassen van het huidige gebruik ervan zal waarschijnlijk moeilijk zijn zonder overtuigend bewijs voor of tegen de effectiviteit ervan.
Differences between countries
There was unanimity amongst the Guideline Development Group members around the indications and the use of amniotomy within member countries, and of the recommendation below.
Binnen de werkgroep bestond unanieme overeenstemming over de indicaties en het gebruik van amniotomie binnen de vertegenwoordigde landen, evenals over de hiernavolgende aanbeveling.
Recommendation
Rational of the recommendation
While it is arguably inappropriate to undertake procedures without a reliable evidence base, based on the current study and wide practice, a recommendation to ban this procedure cannot be done. The authors highlight the other benefits of amniotomy than possibly accelerating the birth process, which are assessing the presence or absence of meconium, and enabling the application of a fetal electrode when required.
According to the authors, an unnecessary amniotomy may increase the chance of umbilical cord prolapse, ascending infection, and vertical transmission or certain pathogens. There are conflicting findings, however, regarding prolonged rupture of membranes and an increase of vertical transmission of HCV, possibly untreated HIV, HBV and other infections (Tosone, 2014; Cotter, 2012; Bopegamage, 2013; Cheung, 2018). It is also acknowledged that other adverse fetomaternal effects cannot be ruled out based on the limited existing evidence.
Considering all of the above it was the opinion of the Guideline Development Group that amniotomy alone, after an informed discussion parent(s), may be a reasonable option when arrested or protracted labour is defined.
Hoewel het mogelijk ongepast is om interventies uit te voeren zonder solide bewijs, kan op basis van de huidige studie en de brede klinische toepassing geen aanbeveling worden gedaan om amniotomie te verbieden. De auteurs benadrukken dat amniotomie, naast het mogelijk versnellen van het geboorteproces, ook andere voordelen biedt, zoals het beoordelen van de aanwezigheid van meconium en het mogelijk maken van het plaatsen van een foetale elektrode indien nodig.
Volgens de auteurs kan een onnodige amniotomie het risico verhogen op navelstrengprolaps, opstijgende infecties en verticale transmissie van bepaalde pathogenen. Er zijn echter tegenstrijdige bevindingen over het verband tussen langdurig gebroken vliezen en een verhoogde verticale transmissie van HCV, mogelijk onbehandelde HIV, HBV en andere infecties (Tosone, 2014; Cotter, 2012; Bopegamage, 2013; Cheung, 2018). Ook wordt erkend dat andere nadelige foeto-maternale effecten niet kunnen worden uitgesloten op basis van het beperkte beschikbare bewijs.
Gelet op het bovenstaande is het de mening van de werkgroep dat amniotomie als op zichzelf staande interventie, na een geïnformeerd gesprek met de barende, een redelijke optie kan zijn wanneer er sprake is van een niet-vorderende ontsluiting.
Onderbouwing
Achtergrond
Artificial rupture of membranes (AROM), also referred to as amniotomy, has been traditionally used to augment slowly progressing labour and is recommended by internatioal guidelines with or without oxytocin augmentation (NICE, 2017; Abou-Dakn, 2022, ACOG, 2024). However, the WHO recommends combined amniotomy and oxytocin and advises against the use of aminotomy alone for labour augmentation (WHO, 2014). The WHO notes that the limited available data are unable to support conclusions on the benefits or harms of routine amniotomy alone for treatment of dysfunctional labour, and that most of the studies have been performed in the setting of early amniotomy to augment or induce labour. We therefore felt it of value to reassess the data on the use of amniotomy in the setting of augmenting an arrested or protracted active 1st stage of labour.
Conclusies / Summary of Findings
Conclusions
|
Very low GRADE |
The evidence is very uncertain about the effect of amniotomy on the Apgar score <7 at 5 minutes when compared with no amniotomy in nulliparous women in the active 1st stage of spontaneous and induced labour, with arrested or protracted labour at term (gestational age ≥ 37/0 weeks) and with a foetus in cephalic presentation.
Source: Blanch, 1998 |
|
Very low GRADE |
The evidence is very uncertain about the effect of amniotomy on the incidence of caesarean section when compared with no amniotomy in nulliparous women in the active 1st stage of spontaneous and induced labour, with arrested or protracted labour at term (gestational age ≥ 37/0 weeks) and with a foetus in cephalic presentation.
Source: Blanch, 1998 |
|
Very low GRADE |
The evidence is very uncertain about the effect of amniotomy on instrumental vaginal delivery when compared with no amniotomy in nulliparous women in the active 1st stage of spontaneous and induced labour, with arrested or protracted labour at term (gestational age ≥ 37/0 weeks) and with a foetus in cephalic presentation.
Source: Blanch, 1998 |
|
Very low GRADE |
The evidence is very uncertain about the effect of amniotomy on duration of labour when compared with no amniotomy in nulliparous women in the active 1st stage of spontaneous and induced labour, with arrested or protracted labour at term (gestational age ≥ 37/0 weeks) and with a foetus in cephalic presentation.
Source: Blanch, 1998 |
|
Very low GRADE |
The evidence is very uncertain about the effect of amniotomy on satisfaction with childbirth experience when compared with no amniotomy in nulliparous women in the active 1st stage of spontaneous and induced labour, with arrested or protracted labour at term (gestational age ≥ 37/0 weeks) and with a foetus in cephalic presentation.
Source: Blanch, 1998 |
|
No GRADE |
No evidence was found regarding the effect of amniotomy on perinatal death, umbilical cord (artery) pH <7, Sarnat score, Thompson score, encephalopathy, anal sphincter rupture, incontinence, haemorrhage >1,000 mL, infection, breastfeeding, bonding and later caesarean section at maternal request when compared with no amniotomy in nulliparous women in the active 1st stage of spontaneous and induced labour, with arrested or protracted labour at term (gestational age ≥ 37/0 weeks) and with a foetus in cephalic presentation. |
Samenvatting literatuur
Description of studies
Smyth (2013) performed a Cochrane review to determine the effectiveness and safety of amniotomy alone for routinely shortening all labours that start spontaneously. In total, 15 randomised controlled trials were included comparing amniotomy alone versus intention to preserve the membranes in pregnant women in spontaneous labour with singleton pregnancies regardless of parity and gestation at trial entry. In 14 of the included studies the study population was not limited to women with dystocia.
Only the study of Blanch (1998) assessed pregnant women with spontaneous labours that had become prolonged. Inclusion criteria were nulliparous or multiparous women with dysfunctional labour where women have not progressed satisfactorily diagnosed using a partogram), a singleton fetus in cephalic presentation, a gestation of at least 37 weeks, full cervical effacement, cervical dilatation of at least 3 cm, regular uterine contractions at least every 5 minutes lasting at least 20 seconds, no known contraindication to oxytocin, and no evidence of fetal hypoxia. Sixty-one women making slow progress in the active phase of spontaneous labour with intact membranes were randomized to oxytocin and AROM (n=21), AROM only (n=20) or expectant management (n=19). For the purpose of this module, subjects who underwent amniotomy only were compared with subjects receiving no amniotomy (expectant management). Groups were comparable at baseline. The outcomes caesarean section, maternal satisfaction, Apgar score, epidural, oxytocin use, instrumental vaginal delivery, NICU admission, cord pH and duration of labour were assessed. Due to the slow rate of recruitment, before completing the recruitment.
Results
1. Perinatal death (critical)
Not reported.
2. Apgar score <7 at 5 minutes (critical)
Blanch (1998) reported an Apgar score of less than 7 at 5 minutes in one of the 20 women (5%) undergoing amniotomy as compared to none of the 19 women receiving no amniotomy (RR=2.86, 95% CI 0.12 to 66.11).
3. Umbilical cord (artery) pH <7 (critical)
Not reported.
4. Sarnat score (critical)
Not reported.
5. Thompson score (critical)
Not reported.
6. Encephalopathy (critical)
Not reported.
7. Caesarean section (important)
Blanch (1998) reported that two of the 20 women (10%) who underwent amniotomy had a caesarean section as compared to two of the 19 women (10.5%) without amniotomy (RR=0.95, 95% CI 0.15 to 6.08).
a. For suspected fetal hypoxia
Blanch (1998) reported that one of the 20 women (5%) who underwent amniotomy had a caesarean section for fetal distress as compared to none of the 19 women without amniotomy (RR=2.86, 95% CI 0.12 to 66.11).
b. For prolonged labour
Blanch (1998) reported that one of the 20 women (5%) who underwent amniotomy had a caesarean section for prolonged labour as compared to two of the 19 women (10.5%) without amniotomy (RR=0.48, 95% CI 0.05 to 4.82).
8. Instrumental vaginal delivery (important)
Blanch (1998) reported that instrumental vaginal delivery occurred in four of the 20 women (25%) who underwent amniotomy as compared to three of the 19 women (16%) without amniotomy (RR=1.27, 95% CI 0.33 to 4.93).
9. Duration of labour (important)
Blanch (1998) reported that the duration of labour was 406 minutes for women who underwent amniotomy as compared to 463 minutes for women without amniotomy (p = 0.32).
10. Anal sphincter rupture (important)
Not reported.
11. Incontinence (important)
Not reported.
12. Haemorrhage >1000 mL (important)
Not reported.
13. Infection (important)
Not reported.
14. Satisfaction with childbirth experience (important)
Blanch (1998) reported a higher maternal satisfaction with childbirth experience for women undergoing amniotomy (mean score of 140, SD=28) as compared to women without amniotomy (mean score of 118, SD=33) (MD=22, 95% CI 2.74 to 41.26).
15. Breastfeeding (important)
Not reported.
16. Bonding (important)
Not reported.
17. Later caesarean section at maternal request (important)
Not reported.
Level of evidence of the literature
According to GRADE, systematic reviews of randomized controlled trials (RCTs) start at a high level of evidence.
The level of evidence regarding the outcome measure Apgar score <7 at 5 minutes was downgraded by four levels to ‘very low’ because of lack of blinding (-1, risk of bias), the population consisted of both nulliparous and multiparous women (-1, indirectness), and the 95% confidence interval crossed both margins of clinical relevance (-2, imprecision).
The level of evidence regarding the outcome measure caesarean section was downgraded by four levels to ‘very low’ because of lack of blinding (-1, risk of bias), the population consisted of both nulliparous and multiparous women (-1, indirectness), and the 95% confidence interval crossed both margins of clinical relevance (-2, imprecision).
The level of evidence regarding the outcome measure instrumental vaginal delivery was downgraded by four levels to ‘very low’ because of lack of blinding (-1, risk of bias), the population consisted of both nulliparous and multiparous women (-1, indirectness), and the 95% confidence interval crossed both margins of clinical relevance (-2, imprecision).
The level of evidence regarding the outcome measure duration of labour was downgraded by three levels to ‘very low’ because of lack of blinding (-1, risk of bias), the population consisted of both nulliparous and multiparous women (-1, indirectness), and the optimal information size was not achieved (-1, imprecision).
The level of evidence regarding the outcome measure satisfaction with childbirth experience was downgraded by three levels to ‘very low’ because of lack of blinding (-1, risk of bias), the population consisted of both nulliparous and multiparous women (-1, indirectness), and the optimal information size was not achieved (-1, imprecision).
The level of evidence regarding the outcome measures perinatal death, umbilical cord (artery) pH <7, Sarnat score, Thompson score, encephalopathy, anal sphincter rupture, incontinence, haemorrhage >1,000 mL, infection, breastfeeding, bonding and later caesarean section at maternal request could not be assessed with GRADE.
Zoeken en selecteren
A systematic review of the literature was performed to answer the following question:
What are the (un)wanted effects of amniotomy in nulliparous women at term (gestational age ≥ 37/0 weeks) and with a fetus in cephalic presentation during the active phase or first stage of labour with arrested or protracted labour?
|
Patients |
Nulliparous women at term (gestational age ≥ 37/0 weeks) and with a fetus in cephalic presentation in the active 1st stage of labour, with arrested or protracted labour |
|
Intervention |
Amniotomy |
|
Control |
No amniotomy |
|
Outcomes |
Perinatal death, Apgar score <7 at 5 minutes, umbilical cord (artery) pH<7.0, Sarnat score, Thompson score, encephalopathy, caesarean section, instrumental vaginal delivery, duration of labour, anal sphincter rupture, incontinence, haemorrhage |
Relevant outcome measures
The guideline development group considered perinatal death, Apgar score <7 at 5 minutes, umbilical cord (artery) pH <7.0, Sarnat score, Thompson score and encephalopathy as critical outcome measures for decision making; and caesarean section, instrumental vaginal delivery, duration of labour, anal sphincter rupture, incontinence, haemorrhage >1,000 mL, infection, satisfaction/childbirth experience, breastfeeding, bonding and later caesarean section at maternal request 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 RR<0.95 or RR>1.05 as a minimal clinically (patient) important difference for the outcome measures perinatal death and encephalopathy. For the other outcomes, RR<0.8 or RR>1.25 was considered 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 July, 2022. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 124 hits. Studies were selected based on the following criteria:
-
Systematic reviews, randomized controlled trials (RCTs) or comparative observational studies
- Nulliparous women at term (gestational age ≥ 37/0 weeks) and with a foetus in cephalic presentation during the dilatation phase or active 1st stage of spontaneous and induced labour, with arrested or protracted labour
- Comparison of amniotomy versus no amniotomy
- Assessing one or more of the predefined outcomes.
- Articles published from 1990 to July 2022
- Publications in English.
Eighteen studies were initially selected based on title and abstract. After reading the full text, seventeen studies were excluded (see the exclusion table with reasons for exclusion under the tab Methods), and one study was included.
Results
One study was included in the analysis of the literature. Important study characteristics and results are summarized in the evidence tables. Assessment of the risk of bias is summarized in the risk of bias tables.
Referenties
- Abou-Dakn M, Schäfers R, Peterwerth N, Asmushen K, Bässler-Weber S, Boes U, Bosch A, Ehm D, Fischer T, Greening M, Hartmann K, Heller G, Kapp C, von Kaisenberg C, Kayer B, Kranke P, Lawrenz B, Louwen F, Loytved C, Lütje W, Mattern E, Nielsen R, Reister F, Schlösser R, Schwarz C, Stephan V, Kalberer BS, Valet A, Wenk M, Kehl S. Vaginal Birth at Term - Part 1. Guideline of the DGGG, OEGGG and SGGG (S3-Level, AWMF Registry No. 015/083, December 2020). Geburtshilfe Frauenheilkd. 2022 Nov 3;82(11):1143-1193.
- Abou-Dakn M, Schäfers R, Peterwerth N, Asmushen K, Bässler-Weber S, Boes U, Bosch A, Ehm D, Fischer T, Greening M, Hartmann K, Heller G, Kapp C, von Kaisenberg C, Kayer B, Kranke P, Lawrenz B, Louwen F, Loytved C, Lütje W, Mattern E, Nielsen R, Reister F, Schlösser R, Schwarz C, Stephan V, Kalberer BS, Valet A, Wenk M, Kehl S. Vaginal Birth at Term - Part 2. Guideline of the DGGG, OEGGG and SGGG (S3-Level, AWMF Registry No. 015/083, December 2020). Geburtshilfe Frauenheilkd. 2022 Nov 3;82(11):1194-1248.
- ACOG Committee Opinion No. 766 Summary: Approaches to Limit Intervention During Labor and Birth. Obstet Gynecol. 2019 Feb;133(2):406-408.
- Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ. 2016 Jun 28;353:i2016.
- Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089.
- Blanch G, Lavender T, Walkinshaw S, Alfirevic Z. Dysfunctional labour: a randomised trial. Br J Obstet Gynaecol. 1998 Jan;105(1):117-20.
- Bopegamage S, Kacerovsky M, Tambor V, Musilova I, Sarmirova S, Snelders E, de Jong AS, Vari SG, Melchers WJ, Galama JM. Preterm prelabor rupture of membranes (PPROM) is not associated with presence of viral genomes in the amniotic fluid. J Clin Virol. 2013 Nov;58(3):559-63.
- Cheung KW, Seto MTY, So PL, Wong D, Mak ASL, Lau WL, Wang W, Kan ASY, Lee CP, Ng EHY. The effect of rupture of membranes and labour on the risk of hepatitis B vertical transmission: Prospective multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2019 Jan;232:97-100.
- Cotter AM, Brookfield KF, Duthely LM, Gonzalez Quintero VH, Potter JE, O'Sullivan MJ. Duration of membrane rupture and risk of perinatal transmission of HIV-1 in the era of combination antiretroviral therapy. Am J Obstet Gynecol. 2012 Dec;207(6):482.e1-5.
- National Institute for Health and Care-Excellence (NICE): Intrapartum Care. Care of healthy woman and their babies during childbirth. Clinical guideline [CG 190]. NICE CG190 2014 updated 02/2017. Version 2 https://www.nice.org.uk/guidance/cg190/evidence/full-guideline-pdf-248734770.
- Santesso N, Glenton C, Dahm P, Garner P, Akl EA, Alper B, Brignardello-Petersen R, Carrasco-Labra A, De Beer H, Hultcrantz M, Kuijpers T, Meerpohl J, Morgan R, Mustafa R, Skoetz N, Sultan S, Wiysonge C, Guyatt G, Schünemann HJ; GRADE Working Group. GRADE guidelines 26: informative statements to communicate the findings of systematic reviews of interventions. J Clin Epidemiol. 2020 Mar;119:126-135.
- Smyth RM, Alldred SK, Markham C. Amniotomy for shortening spontaneous labour. Cochrane Database Syst Rev. 2013 Jan 31;(1):CD006167. Update in: Cochrane Database Syst Rev. 2013;(6):CD006167.
- Tosone G, Maraolo AE, Mascolo S, Palmiero G, Tambaro O, Orlando R. Vertical hepatitis C virus transmission: Main questions and answers. World J Hepatol. 2014 Aug 27;6(8):538-48.
- WHO. WHO recommendations for augmentation of labour. 2014. ISBN 978 92 4 150736 3 https://apps.who.int/iris/bitstream/handle/10665/112825/9789241507363_eng.pdf;jsessionid=EF47C4BC121DBE61E5C6168E25CDDF86?sequence=1.
Verantwoording
Beoordelingsdatum en geldigheid
Publicatiedatum : 01-04-2026
Beoordeeld op geldigheid : 01-04-2026
Validity period
The Board of the Dutch Society of Obstetrics and Gynaecology (NVOG) will assess whether these guidelines are still up to date in 2029 at the latest. If necessary, a new working group will be appointed to revise the guideline. The guideline’s validity may lapse earlier if new developments demand revision at an earlier date.
As the holder of this guideline, the NVOG is chiefly responsible for keeping the guideline up to date. Other scientific organizations participating in the guideline or users of the guideline share the responsibility to inform the chiefly responsible party about relevant developments within their fields.
Algemene gegevens
In collaboration with:
- Deutsche Gesellschaft für Gynäkologie und Geburtshilfe
- Vlaamse Vereniging voor Obstetrie en Gynaecologie
- Federação das Sociedades Portuguesas de Obstetricia e Ginecologia
- Svensk Förening För Obstetrik & Gynekologi
- Hellenic Society of Obstetric and Gynecological Emergency
- Schweizerische Gesellschaft für Gynäkologie und Geburtshilfe
- Dansk Selskab for Obstetrik og Gynækologi
- Česká gynekologická a porodnická společnost
- European Midwives Association
Samenstelling werkgroep
Composition guideline development panel
An international panel for the development of the guidelines was formed in 2019. The panel consisted of representatives from all relevant medical disciplines that are involved in medical care for pregnant women.
All panel members have been officially delegated for participation in the guideline development panel by their (scientific) societies. The panel has developed the guidelines in the period from January 2022 until May 2024.
The guideline development panel is responsible for the entire text of this guideline.
All panel members have been officially delegated for participation in the guideline development panel by their scientific societies. The guideline development panel is responsible for the entire text of this guideline.
Members of the EAPM Standing Committee on Guideline Development (SCGD)
- J.J. Duvekot, obstetrician, Consultant Obstetrics and Gynaecology, Erasmus Medical Centre, Rotterdam, the Netherlands (chair)
- D. Ayres de Campos, obstetrician, Consultant Obstetrics and Gynaecology, Faculdade de Medicina, Lisbon, Portugal
- S. Brismar-Wendel, obstetrician, Consultant Obstetrics and Gynaecology, Danderyd Hospital, Stockholm, Sweden
- G. Daskalakis, obstetrician, Consultant Obstetrics and Gynaecology, National & Kapodistrian University, Athens, Creece.
- I. Dehaene, obstetrician, Consultant Obstetrics and Gynaecology, Ghent University Hospital Belgium
- M. Kacerovsky, obstetrician, Consultant Obstetrics and Gynaecology, University Hospital Hradec Kralove, Czech Republic
- S. Kehl, obstetrician, Consultant Obstetrics and Gynaecology, Erlangen University Hospital, Erlangen, Germany
- Julie Glavind, obstetrician, Consultant Obstetrics and Gynaecology, Aarhus University Hospital, Aarhus, Denmark
- A. Hamza, obstetrician, Consultant Obstetrics and Gynaecology, University Medical Center of Saarland, Homburg an der Saar, Germany
- M.A. Ledingham, obstetrician, Consultant Obstetrics and Gynaecology, the Queen Elizabeth Hospital Glasgow, UK
- B. Magowan, obstetrician, Consultant Obstetrics and Gynaecology, and previous Co-Chair UK RCOG Guidelines Committee, NHS Borders, Scotland, UK
Advisor committee (part of the committee since September 2023)
- E. Mestdagh, Director of Research and Development, AP University of Applied Sciences and Arts Antwerp, Belgium, Scientific advisor and guideline developer, KNOV, The Netherlands
- I. Wilsens, senior program coördinator development & innovation, KNOV, the Netherlands
- I. van Ee, patient representative, Dutch Patient Federation, the Netherlands
- P. Stenbäck, Midwife, MCHS, Program Director - Midwifery education. School of Business and Healthcare, Arcada University of Applied Sciences, Helsinki, Treasurer, board member EMA, European Midwifes Association, Belgium
- C. Matteo, European Midwives Association
Methodological support
- J. Tuijtelaars, advisor, Knowledge Institute of the Dutch Association of Medical Specialists
- J.H. van der Lee, senior advisor, Knowledge Institute of the Dutch Association of Medical Specialists
Belangenverklaringen
Declarations of interests
The Code for the prevention of improper influence due to conflicts of interest was followed.
The working group members have provided written statements about (financially supported) relations with commercial companies, organisations or institutions related to the subject matter of the guideline during the past three years. Furthermore, inquiries have been made regarding personal financial interests, interests due to personal relationships, interests related to reputation management, interest related to externally financed research and interests related to knowledge valorisation. The chair of the guideline development panel is informed about changes in interests during the development process. The declarations of interests are reconfirmed during the commentary phase. The declarations of interests can be requested at the administrative office of the Knowledge Institute of the Dutch Association of Medical Specialists and are summarised below.
|
Last name |
Principal position |
Ancillary position(s) |
Declared interests |
Action |
|
Duvekot (chair) |
Consultant Obstetrics and Gynaecology, Erasmus MC, Rotterdam |
Director 'Medisch Advies en Expertise Bureau Duvekot' - making expertises on medical calamities |
None |
None |
|
Dehaene |
Consultant Obstetrics and Gynaecology, Ghent University Hospital |
None |
None |
None |
|
Hamza |
Leading Consultant at the department of obstetrics and prenatal medicine Kantonspital Baden |
At the cantonal hospital I am involved in the clinical work, research and development. |
Inovolvement in research and development to improve maternofenal health.
|
None |
|
Ledingham |
Consultant in Maternal and Fetal Medicine, Queen Elizabeth Hospital, Glasgow |
Guideline developer for sign (scottisch intercollegiate guidelines group) |
None |
None |
|
Magowan |
Consultant Obstetrics and Gynaecology, and Co-Chair UK RCOG Guidelines Committee, NHS Borders, Scotland |
Previous Co-chair RCOG Guidelines committee |
None |
None |
|
Stenbäck |
Midwife, MCHS, Program Director - Midwifery education. School of Business and Healthcare. Arcada University of Applied Sciences, Helsinki. Treasurer, board member EMA, European Midwifes, Association, Belgium. |
Program director of Midwifery education, Arcada University of Applied Sciences, Helsinki. full time employment.
Treasurer of European Midwives Association, is a position of trust. EMA is a non-profit and non-governmental organisation of midwives, representing midwifery organisations and associations from the member states of the European Union (EU), the European Economic Area (EEA) and EU applicant countries and Council of Europe. |
None |
None |
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Brismar Wendel |
MD, senior consulant, specialist in obstetrics and gynaecology. Department of Women's Health, Danderyd Hospital |
None |
None |
None |
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Ayres de Campos |
Full Professor of Obstetrics and Gynecology. Medical School, University of Lisbon |
None |
None |
None |
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Daskalakis |
Professor OB/GYN National and Kapodistrian University of Athens |
General obstetrics and Gynecology duties. |
None |
None |
|
Wilsens |
Senior program coördinator development & innovation, KNOV, the Netherlands |
None |
None |
None |
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Glavind |
Senior Consultant in obstetrics, Aarhus University Hospital, Denmark |
Member of the Danish National Obstetrics Guideline Steering Comittee: Responsible for coordinating the process in developing, revising and approving Danish national guidelines in obstetrics including the planning of an annual national guideline meeting to discuss new and revised guidlines. This position is not remunerated. |
None |
None |
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Kehl |
Delegate of the German Society of Perinatal Medicine and German Society of Gynecology and Obstetrics |
None |
None |
None |
|
Mestdagh |
Director of Research and Development - AP University of Applied Sciences and Arts Antwerp - Belgium |
Director of Research and development: |
None |
None |
|
Van Ee |
Dutch Patient federation – adviser patient perspective (fulltime) |
Psoriasis patiens Netherlands - coördinator patient participation and research (unpaid)
|
None |
None |
|
Kacerovsky |
Professor, University Hospital Hradec Kralove, Charles University, Faculty of Medicine in Hradec Kralove, Consultant in Maternal-Fetal Medicine, Hospital Most |
None |
None |
None |
Inbreng patiëntenperspectief
Representation of the patient perspective
Representatives of the Dutch Patient Federation provided review comments. The comments were discussed and where relevant incorporated by the guideline development panel.
This guideline accounts for everyone who gives birth, even though we speak of women and her/she in the guideline.
Implementatie
Implementation
Guideline implementation and practical applicability of the recommendations was taken into consideration during various stages of guideline development. Factors that may promote or hinder implementation of the guideline in daily practice were given specific attention.
The guideline is distributed digitally among all relevant professional groups. The guideline can also be downloaded from the Dutch guideline website: www.richtlijnendatabase.nl.
Werkwijze
Method
AGREE
This guideline has been developed conforming to the requirements of the report of Guidelines for Medical Specialists 3.0 by the advisory committee of the Quality Counsel. This report is based on the AGREE II instrument (Appraisal of Guidelines for Research & Evaluation II) (www.agreetrust.org)(Brouwers, 2010), a broadly accepted instrument in the international community and on the national quality standards for guidelines: “Guidelines for guidelines” (www.zorginstituutnederland.nl).
Identification of subject matter
Since this was a pilot project, the content of the questions and the support base in clinical practice was considered of less importance than the process of international collaboration and learning from each other. The panel made an inventory of clinical questions to be addressed based on their expert opinion and their knowledge of existing guidelines. The ‘Danish national clinical guideline concerning primiparous women with dystocia (lack of progress)’ published in 2015 was also used as a source of clinical questions.
Clinical questions and outcomes
The guideline development panel formulated definitive clinical questions and defined relevant outcome measures (both beneficial land harmful effects). The panel rated the outcome measures as critical, important and not important. Furthermore, where applicable, the panel defined relevant clinical differences.
Strategy for search and selection of literature
For the separate clinical questions, specific search terms were formulated and published scientific articles were searched for in (several) electronic databases. Furthermore, studies were scrutinized by cross-referencing for other included studies. The studies with potentially the highest quality of research were searched for first. The panel members selected literature in pairs (independently of each other) based on title and abstract. A second selection was performed based on full text. The databases, search terms and selection criteria are described in the modules containing the clinical questions.
No definitions were available at the time of performing the search. Therefore, definitions as used in the papers were used.
Quality assessment of individual studies
Individual studies were systematically assessed, based on methodological quality criteria that were determined prior to the search, so that risk of bias could be estimated. This is described in the “risk of bias” tables.
Summary of literature
The relevant research findings of all selected articles are shown in evidence tables. The most important findings in the literature are described in literature summaries. In case there were enough similarities between studies, the study data were pooled.
Grading quality of evidence and strength of recommendations
The strength of the conclusions of the scientific publications was determined using the GRADE-method. GRADE stands for Grading Recommendations Assessment, Development and Evaluation (see http://www.gradeworkinggroup.org/).
GRADE defines four gradations for the quality of scientific evidence: high, moderate, low or very low. These gradations provide information about the amount of certainty about the literature conclusions (http://www.guidelinedevelopment.org/handbook/).
The basic principles of the GRADE method are: formulating and prioritising clinical (patient) relevant outcome measures, a systematic review for each outcome measure, and appraisal of the evidence for each outcome measure based on the eight GRADE domains (domains for downgrading: risk of bias, inconsistency, indirectness, imprecision, and publication bias; domains for upgrading: dose-effect association, large effect, and residual plausible confounding).
GRADE distinguishes four levels for the quality of the scientific evidence: high, moderate, low and very low. These levels refer to the amount of certainty about the conclusion based on the literature, in particular the amount of certainty that the conclusion based on the literature adequately supports the recommendation (Schünemann, 2013; Hultcrantz, 2017).
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GRADE |
Definition |
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High |
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Moderate |
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Low |
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Very low |
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The limits of clinical decision making are very important in grading the evidence in guideline development according to the GRADE methodology (Hultcrantz, 2017). Exceedance of these limits would give rise to adaptation of the recommendation. All relevant outcome measures and considerations need to be taken into account to define the limits of clinical decision making. Therefore, the limits of clinical decision making are not one to one comparable to the minimal clinically relevant difference. In particular for interventions of low costs and without important drawbacks the limit of clinical decision making regarding the effectiveness of the intervention may be lower (i.e. closer to no effect) than the Minimal Clinically Important Difference (MCID) (Hultcrantz, 2017).
Considerations (evidence to decision)
Aspects such as expertise of working group members, patient preferences, costs, availability of facilities, and organisation of healthcare aspects are important to consider when formulating a recommendation. For each clinical question, these aspects are discussed in the paragraph Considerations, using a structured format based on the evidence-to-decision framework of the international GRADE Working Group (Alonso-Coello, 2016a; Alonso-Coello, 2016b). The evidence-to-decision framework is an integral part of the GRADE methodology.
Formulating recommendations
Recommendations provide an answer to the primary question and are based on the best scientific evidence available and the most important considerations. The level of scientific evidence and the importance given to considerations by the working group jointly determine the strength of the recommendation. In accordance with the GRADE method, a low level of evidence for conclusions in the systematic literature review does not rule out a strong recommendation, while a high level of evidence may be accompanied by weak recommendations. The strength of the recommendation is always determined by weighing all relevant arguments.
Knowledge gaps
During the development of this guideline, systematic searches were conducted for research contributing to answering the primary questions. For each primary question, the working group determined whether (additional) scientific research is desirable.
Commentary and authorisation phase
The draft guideline was subjected to commentaries by the scientific societies and patient organisations involved. The draft guideline was also submitted to members of the European Midwives Association (EMA). The comments were collected and discussed with the working group. The feedback was used to improve the guideline; afterwards the working group made the guideline definitive. The final version of the guideline was offered for authorization to the involved scientific societies and patient organisations and was authorized or approved, respectively.
Legal standing of guidelines
Guidelines are not legal prescriptions but contain evidence-based insights and recommendations that care providers should meet in order to provide high quality care. As these recommendations are primarily based on ‘general evidence for optimal care for the average patient’, care providers may deviate from the guideline based on their professional autonomy when they deem it necessary for individual cases. Deviating from the guideline may even be necessary in some situations. If care providers choose to deviate from the guideline, this should be done in consultation with the patient, where relevant. Deviation from the guideline should always be justified and documented.
Literature
Agoritsas T, Merglen A, Heen AF, Kristiansen A, Neumann I, Brito JP, Brignardello-Petersen R, Alexander PE, Rind DM, Vandvik PO, Guyatt GH. UpToDate adherence to GRADE criteria for strong recommendations: an analytical survey. BMJ Open 2017;7:e018593.
Alonso-Coello P, Schünemann HJ, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Rada G, Rosenbaum S, Morelli A, Guyatt GH, Oxman AD; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 1: Introduction. BMJ 2016;353:i2016.
Alonso-Coello P, Oxman AD, Moberg J, Brignardello-Petersen R, Akl EA, Davoli M, Treweek S, Mustafa RA, Vandvik PO, Meerpohl J, Guyatt GH, Schünemann HJ; GRADE Working Group. GRADE Evidence to Decision (EtD) frameworks: a systematic and transparent approach to making well informed healthcare choices. 2: Clinical practice guidelines. BMJ. 2016 Jun 30;353:i2089.
Brouwers MC, Kho ME, Browman GP, Burgers JS, Cluzeau F, Feder G, Fervers B, Graham ID, Grimshaw J, Hanna SE, Littlejohns P, Makarski J, Zitzelsberger L; AGREE Next Steps Consortium. AGREE II: advancing guideline development, reporting and evaluation in health care. CMAJ. 2010 Dec 14;182(18):E839-42.
Hultcrantz M, Rind D, Akl EA, Treweek S, Mustafa RA, Iorio A, Alper BS, Meerpohl JJ, Murad MH, Ansari MT, Katikireddi SV, Östlund P, Tranæus S, Christensen R, Gartlehner G, Brozek J, Izcovich A, Schünemann H, Guyatt G. The GRADE Working Group clarifies the construct of certainty of evidence. J Clin Epidemiol. 2017 Jul;87:4-13.
Medisch Specialistische Richtlijnen 2.0 (2012). Adviescommissie Richtlijnen van de Raad Kwalitieit. http://richtlijnendatabase.nl/over_deze_site/over_richtlijnontwikkeling.html
Neumann I, Santesso N, Akl EA, Rind DM, Vandvik PO, Alonso-Coello P, Agoritsas T, Mustafa RA, Alexander PE, Schünemann H, Guyatt GH. A guide for health professionals to interpret and use recommendations in guidelines developed with the GRADE approach. J Clin Epidemiol. 2016 Apr;72:45-55. doi: 10.1016/j.jclinepi.2015.11.017. Epub 2016 Jan 6. Review. PubMed PMID: 26772609.
Schünemann H, Brożek J, Guyatt G, et al. GRADE handbook for grading quality of evidence and strength of recommendations. Updated October 2013. The GRADE Working Group, 2013. Available from http://gdt.guidelinedevelopment.org/central_prod/_design/client/handbook/handbook.html.
Schünemann HJ, Oxman AD, Brozek J, Glasziou P, Jaeschke R, Vist GE, Williams JW Jr, Kunz R, Craig J, Montori VM, Bossuyt P, Guyatt GH; GRADE Working Group. Grading quality of evidence and strength of recommendations for diagnostic tests and strategies. BMJ. 2008 May 17;336(7653):1106-10.
Schünemann, A Holger J [corrected to Schünemann, Holger J]. PubMed PMID: 18483053; PubMed Central PMCID: PMC2386626.
Wessels M, Hielkema L, van der Weijden T. How to identify existing literature on patients' knowledge, views, and values: the development of a validated search filter. J Med Libr Assoc. 2016 Oct;104(4):320-324.