Single-layer vs double-layer uterine closure during cesarean delivery: 3-year follow-up of a randomized controlled trial (2Close study) - 22/08/24
On behalf of the
2Close study group
Abstract |
Background |
The rising rate of cesarean deliveries has led to an increased incidence of long long-term complications, including niche formation in the uterine scar. Niche development is associated with various gynecologic complaints and complications in subsequent pregnancies, such as uterine rupture and placenta accreta spectrum disorders. Although uterine closure technique is considered a potential risk factor for niche development, consensus on the optimal technique remains elusive.
Objective |
We aimed to evaluate the effect of single-layer vs double-layer closure of the uterine incision on live birth rate at a 3-year follow-up with secondary objectives focusing on gynecologic, fertility, and obstetrical outcomes at the same follow-up.
Study Design |
A multicenter, double-blind, randomized controlled trial was performed at 32 hospitals in the Netherlands. Women ≥18 years old undergoing a first cesarean delivery were randomly assigned (1:1) to receive either single-layer or double-layer closure of the uterine incision. The primary outcome of the long-term follow-up was the live birth rate; with secondary outcomes, including pregnancy rate, the need for fertility treatment, mode of delivery, and obstetrical and gynecologic complications. This trial is registered on the International Clinical Trials Registry Platform www.who.int (NTR5480; trial finished).
Results |
Between 2016 and 2018, the 2Close study randomly assigned 2292 women, with 830 of 1144 and 818 of 1148 responding to the 3-year questionnaire in the single-layer and double-layer closure. No differences were observed in live birth rates; also there were no differences in pregnancy rate, need for fertility treatments, mode of delivery, or uterine ruptures in subsequent pregnancies. High rates of gynecologic symptoms, including spotting (30%–32%), dysmenorrhea (47%–49%), and sexual dysfunction (Female Sexual Function Index score, 23) are reported in both groups.
Conclusion |
The study did not demonstrate the superiority of double-layer closure over single-layer closure in terms of reproductive outcomes after a first cesarean delivery. This challenges the current recommendation favoring double-layer closure, and we propose that surgeons can choose their preferred technique. Furthermore, the high risk of gynecologic symptoms after a cesarean delivery should be discussed with patients.
Le texte complet de cet article est disponible en PDF.Key words : cesarean delivery, cesarean scar, follow-up, long-term outcomes, niche, reproductive health, uterine closure technique
Plan
| A full list of collaborators is provided in the appendix. |
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| International Clinical Trials Registry Platform www.who.int (NTR5480; trial finished). |
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| Funding was by ZonMw; the funding source had no role in the collection, analysis and interpretation of data, in the writing of the report and in the decision to submit the article for publication. |
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| J.A.F.H. received grants from ZonMw for the conduct of the study, and additionally received grants from Samsung, NWO-TTW and PlantTec Medical GmbH, and a fee from Olympus, all outside the submitted work. An institutional grant was received from Olympus, Hologic, Benetec and Medical Dynamics, outside the submitted work. C.J.M.d.G. received a grant from ZonMw outside the submitted work. All other authors declare no competing interests. |
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| Deidentified individual participant data collected during the 2Close trial will be shared at 1 year after publication of the long-term results on reasonable request to the corresponding author (j.huirne@amsterdamumc.nl). Approval of a proposal will be necessary before data will be shared. The informed consent form will also be made available on reasonable request to the corresponding author. To gain access, requesters will need to sign an agreement form and confirm that data will be used for the purpose for which access was granted. |
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| Cite this article as: Carry Verberkt C, Stegwee SI, Van der Voet LF, et al. Single-layer vs double-layer uterine closure during cesarean delivery: 3-year follow-up of a randomized controlled trial (2Close study). Am J Obstet Gynecol 2024;231:346.e1-11. |
Vol 231 - N° 3
P. 346.e1-346.e11 - septembre 2024 Retour au numéro
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