Clinical Trial

Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial

Recruiting
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Record status
This record was last updated March 13, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.
Summary
The objective of this randomized monocentric study is to assess potential variations in the incidence and severity of isthmocele morbidity among women undergoing cesarean section with either single or double-layer closure of the hysterotomy. Our primary outcome aims to investigate whether there is a reduction in the median duration of intermenstrual spotting in patients belonging to the two respective closure groups
Trial Details
NCT Number NCT06308172
Lead Sponsor Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Conditions Cesarean Section; Dehiscence, Uterine Bleeding, Uterus; Scar, Uterus Abnormal, Cesarean Section Complications
Enrollment 150 participants
Start Date 2021-12-01
Primary Completion 2024-12-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2024-03-13