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, C.J.M. de Groot, J.A.F. Huirne*, 2Close study group

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

Abstract

Objective To 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.

Design Multicentre, double-blind, randomised controlled superiority trial.

Setting Thirty-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.

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

Main outcome measures Number of days with postmenstrual spotting during one menstrual cycle 9 months after CS. Secondary outcomes: perioperative and menstrual characteristics; transvaginal ultrasound measurements.

Results A 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.

Conclusions The 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.

Original languageEnglish
Pages (from-to)866-878
Number of pages13
JournalBjog-an International Journal of Obstetrics and Gynaecology
Volume128
Issue number5
DOIs
Publication statusPublished - 1 Apr 2021

Keywords

  • Caesarean section
  • double layer
  • niche
  • postmenstrual spotting
  • single layer
  • uterine closure technique
  • RISK-FACTORS
  • NICHE
  • INCISION
  • SCAR
  • PREVALENCE
  • FACTORIAL
  • SYMPTOMS
  • OUTCOMES
  • CORONIS
  • TERM

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