Clinical Trial

High vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean

Study acronym: HISEAL
Recruiting
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Summary
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2024-09-27; most recent amendment 2026-05-05.
Status change: Not Yet Recruiting → Recruiting 2026-05-05
Trial Details
NCT Number NCT06620432
Lead Sponsor Fundacion Clinica Valle del Lili
Conditions Placenta Accreta Spectrum
Enrollment 168 participants
Start Date 2025-06-12
Primary Completion 2026-11-30 (estimated)
Study Completion 2027-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-07