Evidence map›Paper›PMID 32892392›Full record

Trial reportBJOG : an international journal of obstetrics and gynaecology2021

Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close): multicentre, double-blind, randomised controlled superiority trial.

S I Stegwee, L F van der Voet, A J Ben, R A de Leeuw, P M van de Ven, R G Duijnhoven, M Y Bongers, C B Lambalk, Cjm de Groot, Jaf Huirne and 1 more

Open access · hybridAbstract readEquivalence TrialMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BJOG : an international journal of obstetrics and gynaecology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 27 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 1 pooled it
3.1field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 1 synthesis or guideline pooled it, 64 citations in OpenAlex.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 5 institutions in 3 countries.

S I StegweeDepartment of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0003-1353-5576
L F van der VoetDepartment of Obstetrics and Gynaecology, Deventer Hospital, Deventer, the Netherlands.ORCID 0000-0001-5389-646X
A J BenDepartment of Health Sciences, Amsterdam Public Health, Faculty of Science, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0003-4793-9026
R A de LeeuwDepartment of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-9344-7754
P M van de VenDepartment of Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.
R G DuijnhovenDepartment of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Universiteit van Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-4784-4396
M Y BongersDepartment of Obstetrics and Gynaecology, Máxima Medical Centre, Research School Grow Maastricht University, Veldhoven, the Netherlands.
C B LambalkDepartment of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0003-3947-5129
Cjm de GrootDepartment of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0003-3277-2542
Jaf HuirneDepartment of Obstetrics and Gynaecology, Amsterdam Reproduction & Development, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, the Netherlands.ORCID 0000-0002-8248-2677
2Close study group
Amsterdam University Medical Centers · NLDepartment of Health · ZADeventer Ziekenhuis · NLH.B. Fuller (United States) · USRadboud University Nijmegen · NL

Funding

ZonMw: The Netherlands Organisation for Health Research and Development 843002605
6 · The paper itself

Abstract

objectiveTo evaluate whether double-layer uterine closure after a first caesarean section (CS) is superior compared with single-layer uterine closure in terms of postmenstrual spotting and niche development in the uterine caesarean scar.

designMulticentre, double-blind, randomised controlled superiority trial.

settingThirty-two hospitals in the Netherlands. POPULATION: A total of 2292 women aged ≥18 years undergoing a first CS were randomly assigned to each procedure (1:1): 1144 women were assigned to single-layer uterine closure and 1148 women were assigned to double-layer uterine closure.

methodsSingle-layer unlocked closure and double-layer unlocked closure, with the second layer imbricating the first.

main outcome measuresNumber of days with postmenstrual spotting during one menstrual cycle 9 months after CS. SECONDARY OUTCOMES: perioperative and menstrual characteristics; transvaginal ultrasound measurements.

resultsA total of 774 (67.7%) women from the single-layer group and 770 (67.1%) women from the double-layer group were evaluable for the primary outcome, as a result of drop-out and amenorrhoea. The mean number of postmenstrual spotting days was 1.33 (bootstrapped 95% CI 1.12-1.54) after single-layer closure and 1.26 (bootstrapped 95% CI 1.07-1.45) after double-layer closure (adjusted mean difference -0.07, 95% CI -0.37 to 0.22, P = 0.810). The operative time was 3.9 minutes longer (95% CI 3.0-4.9 minutes, P < 0.001) and niche prevalence was 4.7% higher (95% CI 0.7-8.7%, P = 0.022) after double-layer closure.

conclusionsThe superiority of double-layer closure compared with single-layer closure in terms of postmenstrual spotting after a first CS was not shown. Long-term obstetric follow-up of our trial is needed to assess whether uterine caesarean closure guidelines should be adapted. TWEETABLE ABSTRACT: Double-layer uterine closure is not superior for postmenstrual spotting after a first caesarean; single-layer closure performs slightly better on other outcomes.

Indexed as

Suture TechniquesAdultCesarean SectionDouble-Blind MethodFemaleFollow-Up StudiesHumansLinear ModelsMenstruation DisturbancesPostoperative ComplicationsPregnancyTreatment OutcomeCaesarean sectiondouble layernichepostmenstrual spottingsingle layeruterine closure technique

Identifiers

PMID32892392
PMCPMC7983985
OpenAlexW3083396955

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.