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

Study acronym: HISEAL
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Start date changed from estimate of Dec 1, 2024 to Jun 12, 2025
    • Primary completion date: Jun 30, 2026 to Nov 30, 2026
    • Study completion date: Oct 31, 2026 to Aug 31, 2027
    • Site details revised
  2. Start date: Oct 1, 2024 to Dec 1, 2024v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06620432
Lead Sponsor Fundacion Clinica Valle del Lili
Conditions
(from sponsor)		 Placenta Accreta Spectrum
Related terms Placenta Accreta
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov