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HIPAA Compliant
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Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
ID06308172

Comparing Single- and Double-layer Closure of Cesarean Incision to Reduce Uterine Scar Complications and Spotting

Led by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Updated on 2024-03-13

150

Participants Needed

1

Research Sites

104 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the impact of single-layer versus double-layer hysterotomy closure techniques on the development of cesarean niche isthmocele and related morbidity in women undergoing elective cesarean sections. The study aims to compare the incidence and severity of isthmocele and to determine if there is a reduction in the median duration of intermenstrual spotting between the two closure methods. This randomized controlled trial addresses limitations of previous research by standardizing the surgical technique and focusing on women without labor during cesarean delivery. The study involves two groups one receiving a single-layer unlocked suture closure of the hysterotomy and the other receiving a double-layer unlocked suture closure. Both techniques are being assessed to understand their effects on post-cesarean scar formation and symptoms. The intervention is performed during elective cesarean sections on singleton pregnancies at 38-40 weeks gestation. The trial does not include blinding and uses randomized allocation. Participants will be followed for six months after surgery to assess outcomes such as intermenstrual bleeding duration, intraoperative time, blood loss, use of pain medications, recovery time, time to full mobilization, and the presence of isthmocele. Data collection includes monitoring surgical and recovery parameters as well as symptom tracking. The study helps determine which closure technique may reduce complications after cesarean delivery and improve patient recovery.

CONDITIONS

Brief Title

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

Research Team

G

Giuseppe Perugino, MD

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