TY - JOUR
T1 - Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close): multicentre, double-blind, randomised controlled superiority trial
T2 - multicentre, double-blind, randomised controlled superiority trial
AU - Stegwee, S. I.
AU - van der Voet, L. F.
AU - Ben, A. J.
AU - de Leeuw, R. A.
AU - van de Ven, P. M.
AU - Duijnhoven, R. G.
AU - Bongers, M. Y.
AU - Lambalk, C. B.
AU - de Groot, C. J. M.
AU - Huirne, J. A. F.
AU - 2Close study group
AU - Papatsonis, Dimitri N. M.
AU - Pajkrt, Eva
AU - Hehenkamp, Wouter J. K.
AU - Oei, Angèle L. M.
AU - Bekker, Mireille N.
AU - Schippers, Daniela H.
AU - van Vliet, Huib A. AM
AU - van der Voet, Lucet
AU - Schuitemaker, Nico W. E.
AU - Hemelaar, Majoie
AU - van Baal, W. M.
AU - Huisjes, Anjoke J. M.
AU - Meijer, Wouter J.
AU - Janssen, C. A. H.
AU - Hermes, Wietske
AU - Feitsma, A. H.
AU - van Eijndhoven, Hugo W. F.
AU - Rijnders, Robbert J. P.
AU - Sueters, Marieke
AU - Scheepers, H. C. J.
AU - van Laar, Judith O. EH
AU - Boormans, Elisabeth M. A.
AU - van Kesteren, Paul J. M.
AU - Radder, Celine M.
AU - Hink, Esther
AU - Kapiteijn, Kitty
AU - de Boer, Karin
AU - Kaplan, Mesrure
AU - van Beek, Erik
AU - de Vleeschouwer, L. H. M.
AU - Visser, Harry
AU - Bosmans, Judith E.
AU - el Alili, Mohamed
AU - Langenveld, Josje
N1 - Funding Information: This study was performed with funding from ZonMw: The Netherlands Organisation for Health Research and Development (project no. 843002605). Both the funder of the study and a patient involvement panel approved the study protocol. The funder had no role in study design, data collection, data analysis, data interpretation or writing the article. The corresponding author had full access to all of the data in the study and had final responsibility for the decision to submit for publication. We would like to thank all participants of the 2Close study. Additionally, we would like to thank the Departments of Obstetrics and Gynaecology of all participating hospitals, with special thanks to all research nurses and research midwives for their contribution in data collection. The 2Close study group would like to thank all collaborators from the participating hospitals for their effort. Publisher Copyright: © 2020 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021/4/1
Y1 - 2021/4/1
N2 - 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.
AB - 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.
KW - Caesarean section
KW - double layer
KW - niche
KW - postmenstrual spotting
KW - single layer
KW - uterine closure technique
UR - http://www.scopus.com/inward/record.url?scp=85102301462&partnerID=8YFLogxK
U2 - https://doi.org/10.1111/1471-0528.16472
DO - https://doi.org/10.1111/1471-0528.16472
M3 - Article
C2 - 32892392
SN - 1470-0328
VL - 128
SP - 866
EP - 878
JO - BJOG: An International Journal of Obstetrics and Gynaecology
JF - BJOG: An International Journal of Obstetrics and Gynaecology
IS - 5
ER -