NCT06620432 High vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean
| NCT ID | NCT06620432 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fundacion Clinica Valle del Lili |
| Condition | Placenta Accreta Spectrum |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2025-06-12 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 168 participants in total. It began in 2025-06-12 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Albaro J. Nieto, M.D.
PRINCIPAL INVESTIGATOR
Fundacion Clinica Valle del Lili
Frequently Asked Questions
Who can join the NCT06620432 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Placenta Accreta Spectrum. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06620432 currently recruiting?
Yes, NCT06620432 is actively recruiting participants. Contact the research team at albaro.nieto@fvl.org.co for enrollment information.
Where is the NCT06620432 trial being conducted?
This trial is being conducted at Cali, Colombia.
Who is sponsoring the NCT06620432 clinical trial?
NCT06620432 is sponsored by Fundacion Clinica Valle del Lili. The principal investigator is Albaro J. Nieto, M.D. at Fundacion Clinica Valle del Lili. The trial plans to enroll 168 participants.