High vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean
Recruiting now · Not applicable
Conditions studied: Placenta Accreta Spectrum
In brief
The purpose of this clinical trial is to compare the incidence of defects in the uterine wall at the site of the scar (niche) and surgical complications when using high-segment versus low-segment hysterotomy, with both cross-suturing and non-cross-suturing techniques, in pregnant patients undergoing their first cesarean section. Researchers will compare four arms: * Low Segment Hysterotomy + Crossed hysterorrhaphy * High Segment Hysterotomy + Crossed hysterorrhaphy * Low Segment Hysterotomy + Non-Crossed hysterorrhaphy * High Segment Hysterotomy + Non-Crossed hysterorrhaphy Participants will: * Cesarean delivery * Attend a follow up appointment between 6 to 16 weeks post surgery where will be perform a transvaginal sonography.
Key facts
- Study ID
- NCT06620432
- Run by
- Fundacion Clinica Valle del Lili
- People needed
- 168
- Starts
- 2025-06-12
- Expected to finish
- 2027-08-31
- Last updated by the study team
- 2026-05-07
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Pregnant women aged ≥ 18 years.
- Confirmed pregnancy through clinical history or ultrasound between 36 and 42 weeks of gestation.
- Indication by the attending gynecologist for a first cesarean section, either emergent or elective.
You may not qualify if…
- History of myometrial intervention, such as myomectomy.
- History of genetic or acquired conditions that alter the anatomy of the uterus.
- History of coagulation disorders.
- History of connective tissue disorders, such as Lupus and Scleroderma, which may affect healing.
- Hemodynamically unstable patients due to a clinical condition prior to performing the cesarean section.
- Failure to sign the informed consent.
Where it is running
- Fundación Valle del Lili — Cali, Valle del Cauca Department, Colombia (enrolling)
Full record on ClinicalTrials.gov
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