NCT06308172 Impact of Single- Versus Double-layer Hysterotomy Closure on Cesarean Niche Development: a Randomized Controlled Trial
| NCT ID | NCT06308172 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico |
| Condition | Cesarean Section; Dehiscence |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2024-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2021-12-01 with a primary completion date of 2024-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
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
Contact & Investigator
Giuseppe Perugino, MD
PRINCIPAL INVESTIGATOR
Ospedale Policlinico Maggiore Ca' Granda Milano
Frequently Asked Questions
Who can join the NCT06308172 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Cesarean Section; Dehiscence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06308172 currently recruiting?
Yes, NCT06308172 is actively recruiting participants. Contact the research team at giuseppe.perugino@policlinico.mi.it for enrollment information.
Where is the NCT06308172 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06308172 clinical trial?
NCT06308172 is sponsored by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico. The principal investigator is Giuseppe Perugino, MD at Ospedale Policlinico Maggiore Ca' Granda Milano. The trial plans to enroll 150 participants.