Closing the uterus during cesarean: include or exclude the decidual layer to see if the scar heals better
Official title: The Impact of Decidual Inclusion or Sparing in a Single Unlocked Closure of a Cesarean Uterine Incision: Randomized Controlled Trial
Run by Kantonsspital Baden · NCT07608874 · Data updated 2026-11-12
This randomized trial tests whether including or sparing the decidual layer when closing the uterus at cesarean delivery leads to better scar healing 6 to 9 months later for first-time mothers.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 374 (estimated) |
| Sponsor | Kantonsspital Baden Academic / other |
| Locations | 1 site (Baden, Canton of Aargau) |
| Status | Recruiting |
| Started | June 17, 2026 |
| Main results expected | May 1, 2029 |
| Study ends | May 30, 2029 |
| Registry record updated | August 25, 2026 |
| Trial ID | NCT07608874 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women with singleton, term pregnancies planning an elective cesarean delivery who understand the study and consent to randomization.
✕Probably not a fit
Patients who have emergent cesareans, placenta previa or suspected placenta accreta, diabetes, prior cesareans, or other exclusion criteria may not benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, randomized study compares two single-layer, non-locked uterine closure techniques during elective cesarean sections. One group includes the cavum-near decidual layer in the suture, while the other spares it. All steps are standardized except for how the decidual layer near the uterine margin is handled. Scar healing and the presence of niche or isthmocele defects are assessed by blinded ultrasound 6 to 9 months post-surgery. The goal is to determine if decidual inclusion or sparing influences cesarean scar healing and defect formation.
Why it matters
Potential benefit: If decisive, the findings could inform safer closure techniques to reduce scar defects and potential gynecologic symptoms in future pregnancies.
How similar studies have gone: Previous work has explored uterine closure methods with mixed results; this trial directly tests the impact of decidual inclusion vs sparing on scar healing.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Kantonsspital Baden
Baden, Canton of Aargau, Switzerland Recruiting
Study contacts
- Principal investigator: Amr S. Hamza, Assoc. Prof. — Kantonsspital Baden
- Study coordinator: Amr S. Hamza, Assoc. Prof.
- Email: amr.hamza@ksb.ch
- Phone: +41564863513
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.