High versus low segmental hysterotomy and uterine scar defects after a first cesarean

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.