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

RecruitingNAAges 18 Years - anyFemaleFundacion Clinica Valle del Lili
NCT06620432 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Low segment hysterotomy
  • High segment hysterotomy
  • Crossed hysterorrhaphy
  • Non-Crossed hysterorrhaphy
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Where

1 site
Fundación Valle del Lili
Cali, Colombia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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