Clinical Research Directory
Browse clinical research sites, groups, and studies.
Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
150
Start Date
2021-12-01
Completion Date
2026-12-01
Last Updated
2024-03-13
Healthy Volunteers
No
Conditions
Interventions
Hysterotomy closure
Hysterotomy closure is done in either one of two ways. Single layer closure consists in a single layer, unlocked suture. Double layer closure consists in a double layer, unlocked suture.
Locations (1)
Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano
Milan, Mi, Italy