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

RecruitingNAAges 18 Years - anyFemaleFondazione IRCCS Ca' Granda, Ospedale Maggiore Po…
NCT06308172 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Hysterotomy closure
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Where

1 site
Fondazione Cà Granda IRCCS Ospedale Maggiore Policlinico di Milano
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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