RecruitingNot Applicable

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

Italy150 participantsStarted 2021-12-01

Plain-language 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

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * nulliparous * singleton * age 18-45 * spontaneous pregnancy or autologous assisted fertilization * gestational age 38-40 weeks * elective C-section * informed consent Exclusion Criteria: * coagulopathy * autoimmune diseases * gestational diabetes * anticoagulant therapy * immunosuppressive therapy * endometriosis * uterine fibromatosis * spontaneous labour * connective tissue diseases

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Intermenstrual bleeding reduction (days)

Timeframe: 6 months

Trial details

NCT IDNCT06308172

SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

Contact for this trial

Giuseppe Perugino, MD

3383030553 giuseppe.perugino@policlinico.mi.it

View on ClinicalTrials.gov More Cesarean Section; Dehiscence trials