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

Recruiting now · Not applicable

Conditions studied: Cesarean Section; Dehiscence, Uterine Bleeding, Uterus; Scar, Uterus Abnormal, Cesarean Section Complications

In brief

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 facts

Study ID

NCT06308172

Run by

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

People needed

150

Starts

2021-12-01

Expected to finish

2026-12-01

Last updated by the study team

2024-03-13

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• nulliparous
• singleton
• age 18-45
• spontaneous pregnancy or autologous assisted fertilization
• gestational age 38-40 weeks
• elective C-section
• informed consent

You may not qualify if…

• coagulopathy
• autoimmune diseases
• gestational diabetes
• anticoagulant therapy
• immunosuppressive therapy
• endometriosis
• uterine fibromatosis
• spontaneous labour
• connective tissue diseases

Where it is running

• Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano — Milan, Mi, Italy (enrolling)

Full record on ClinicalTrials.gov

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