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

NCT06620432 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2026-05-07

No results posted yet for this study

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.

Conditions

  • Placenta Accreta Spectrum

Interventions

PROCEDURE

Non-Crossed hysterorrhaphy

Non-crossed hysterorrhaphy is a surgical technique used to close a uterine incision, typically after a hysterotomy, such as during a cesarean section. In this method, the sutures are placed in a linear, parallel fashion rather than in a crossed or X-shaped pattern

PROCEDURE

Crossed hysterorrhaphy

Crossed hysterorrhaphy is a surgical technique used to close the uterine incision following a hysterotomy, particularly during cesarean sections. In this method, the sutures are placed in a crossed or X-shaped pattern, which helps to evenly distribute tension across the incision site.

PROCEDURE

High segment hysterotomy

A high segment hysterotomy is a surgical procedure involving an incision in the upper segment of the uterus.

PROCEDURE

Low segment hysterotomy

A low segment hysterotomy is a surgical procedure in which an incision is made in the lower segment of the uterus, typically during a cesarean section or other uterine surgeries. This approach is preferred because the lower uterine segment is thinner and less vascular, reducing the risk of bleeding and complications during and after the procedure. The incision is typically horizontal.

Sponsors & Collaborators

  • Fundacion Clinica Valle del Lili

    lead OTHER

Principal Investigators

  • Albaro J. Nieto, M.D. · Fundacion Clinica Valle del Lili

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-12
Primary Completion
2026-11-30
Completion
2027-08-31

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06620432 on ClinicalTrials.gov