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RECRUITING Not applicable ClinicalTrials.gov

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

Sponsor: Kantonsspital Baden • ClinicalTrials.gov ID: NCT07608874

Registry updated: 2026-08-25
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Description

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.

Interventions

  • Single-Layered Non-Locked Closure with Decidual Inclusion (Procedure)
    During the cesarean section, the uterine incision is closed with a single-layered, non-locked suture. In this technique, the decidua (the uterine lining) is included in the closure. This means that the endometrial cells are part of the suture, potentially influencing the healing process of the uterine scar. Goal: The idea is that including the decidua may promote better healing and scar formation, reducing the risk of complications such as isthmocele and improving long-term uterine health.
  • Single-Layered Non-Locked Closure with Decidual Sparing (Procedure)
    Procedure: In this technique, the uterine incision is also closed using a single-layered non-locked suture, but the decidua is excluded from the closure. The suture is placed only through the myometrium (muscle layer) of the uterus, leaving the decidua out of the scar tissue. Goal: The intent is to observe if sparing the decidua results in better scar healing and a lower risk of isthmocele formation, as well as fewer long-term complications.

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

Conditions

Isthmocele Cesarean Scar Diverticula

Locations

  • Kantonsspital Baden — Baden, Canton of Aargau, Switzerland
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record