High versus low segmental hysterotomy and uterine scar defects after a first cesarean
High Segmental Hysterotomy vs. Low Segmental Hysterotomy: Association With the Incidence of Uterine Wall Defects After Cesarean Section
We will test whether high or low segmental hysterotomy, with or without cross-suturing, leads to fewer uterine scar defects in people having their first cesarean.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Fundacion Clinica Valle del Lili Academic / other |
| Locations | 1 site (Cali, Valle del Cauca Department) |
| Trial ID | NCT06620432 on ClinicalTrials.gov |
What this trial studies
This single-blind, randomized trial assigns pregnant participants having their first cesarean to one of four groups combining high or low segmental hysterotomy with crossed or non-crossed hysterorrhaphy. The assigned incision and closure are performed by the attending gynecologist at the time of cesarean. Investigators will record intraoperative findings, postoperative recovery, and surgical complications. A transvaginal pelvic ultrasound will be done once between 6 and 16 weeks after delivery to look for isthmocele (uterine niche) and characterize its size and location.
Who should consider this trial
Good fit: Pregnant people aged 18 or older at 36–42 weeks gestation who are scheduled for their first cesarean and are able to provide informed consent are eligible.
Not a fit: People with prior myometrial surgery (e.g., myomectomy), uterine anatomical disorders, coagulation or connective tissue disorders, hemodynamic instability, or who are not undergoing their first cesarean are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, the procedures identified could lower the rate of uterine scar defects (isthmoceles) and related surgical complications after a first cesarean, improving healing and future reproductive outcomes.
How similar studies have performed: Some observational studies and surgical series suggest that incision level and closure technique influence isthmocele formation, but randomized comparisons of high versus low segmental hysterotomy together with crossed versus non-crossed closure are limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Cali, Valle del Cauca Department
- Fundación Valle del Lili — Cali, Valle del Cauca Department, Colombia (Recruiting)
Study contacts
- Principal investigator: Albaro J. Nieto, M.D. — Fundacion Clinica Valle del Lili
- Study coordinator: Albaro J. Nieto, M.D.
- Email: albaro.nieto@fvl.org.co
- Phone: 3319090
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.