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Recruiting NCT07608874

Comparing Decidual Inclusion vs. Exclusion in Uterine Suture Techniques During Cesarean Section to Improve Scar Thickness and Reduce Isthmocele Risk in Primiparous Women

Conditions: Isthmocele, Cesarean Scar Diverticula

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 374
Sponsor: Kantonsspital Baden

Location: Kantonsspital Baden Baden Canton of Aargau

Summary

This study compares two ways of closing the uterus during cesarean delivery. In one group, the decidual layer near the uterine cavity is included in the suture. In the other group, this layer is left out. The study will examine whether these two methods differ in how well the uterine scar heals 6 to 9 months after surgery. Women having an elective cesarean delivery will be randomly assigned to one of the two closure methods. Scar healing will be assessed by ultrasound after delivery. The goal is to determine whether one method is associated with better cesarean scar healing and fewer scar defects.

Eligibility Criteria

Inclusion Criteria: * Singleton, term pregnancy * Elective cesarean section before labor onset or membrane rupture * Maternal age \>18 years * Ability to provide informed consent Exclusion Criteria: * Placenta previa * Maternal substance abuse or infection * Suspected placenta accreta * Diabetes * one or more prior cesarean section * Vulnerable participants (e.g., mental health conditions) * Emergency cesarean sections

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07608874). StuddyBuddy aggregates publicly available trial information.