TY - JOUR
T1 - Effect of single- versus double-layer uterine closure during caesarean section on postmenstrual spotting (2Close)
T2 - multicentre, double-blind, randomised controlled superiority trial
AU - for the 2Close study group
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 - Papatsonis, D.N.M.
AU - Pajkrt, E.
AU - Hehenkamp, W.J.K.
AU - Oei, A.L.M.
AU - Bekker, M.N.
AU - Schippers, D.H.
AU - van Vliet, H.A.A.M.
AU - van der Voet, L.
AU - Schuitemaker, N.W.E.
AU - Hemelaar, M.
AU - van Baal, W.M.
AU - Huisjes, A.J.M.
AU - Meijer, W.J.
AU - Janssen, C.A.H.
AU - Hermes, W.
AU - Feitsma, A.H.
AU - van Eijndhoven, H.W.F.
AU - Rijnders, R.J.P.
AU - Sueters, M.
AU - Scheepers, H.C.J.
AU - van Laar, J.O.E.H.
AU - Boormans, E.M.A.
AU - van Kesteren, P.J.M.
AU - Radder, C.M.
AU - Hink, E.
AU - Kapiteijn, K.
AU - de Boer, K.
AU - Kaplan, M.
AU - van Beek, E.
AU - de Vleeschouwer, L.H.M.
AU - Visser, H.
AU - Bosmans, J.E.
AU - El Alili, M.
AU - Langenveld, J.
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.
U2 - https://doi.org/10.1111/1471-0528.16472
DO - https://doi.org/10.1111/1471-0528.16472
M3 - Article
SN - 1470-0328
VL - 128
SP - 866
EP - 878
JO - BJOG: An International Journal of Obstetrics & Gynaecology
JF - BJOG: An International Journal of Obstetrics & Gynaecology
IS - 5
ER -