Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
ID06620432

High Segmental Hysterotomy vs Low Segmental Hysterotomy: Impact on Uterine Wall Defects After Cesarean Section

Led by Fundacion Clinica Valle del Lili · Updated on 2026-05-07

168

Participants Needed

1

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of different surgical techniques used during a first cesarean section in pregnant women. The study aims to compare how making an incision in either the high or low segment of the uterus, combined with two different suturing methods (crossed and non-crossed hysterorrhaphy), impacts the development of defects in the uterine wall at the scar site, as well as related surgical complications. This is a single-blind, randomized trial conducted to better understand the safety and outcomes of these approaches. Participants will be randomly assigned to one of four groups: low segment hysterotomy with crossed suturing, high segment hysterotomy with crossed suturing, low segment hysterotomy with non-crossed suturing, or high segment hysterotomy with non-crossed suturing. The cesarean section will be performed by the attending gynecologist using the assigned technique, with incision and skin closure done according to the gynecologist's discretion. This procedure is followed by a single follow-up visit scheduled between 6 and 16 weeks post-surgery. During the follow-up appointment, participants will undergo a transvaginal pelvic ultrasound to detect any uterine wall defects (isthmoceles) at the scar site and to assess their size, location, and characteristics if present. Researchers will also measure various aspects of the uterine wall thickness around the defect. The study focuses on the incidence of uterine wall defects and surgical outcomes, with all care and assessments monitored throughout the process. Total participation includes the cesarean delivery and one follow-up ultrasound visit within 6 to 16 weeks after surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Pregnant women aged 18 years or older
  • Confirmed pregnancy between 36 and 42 weeks of gestation
  • Indication by attending gynecologist for a first cesarean section, emergent or elective
Not Eligible

You will not qualify if you...

  • History of myometrial intervention such as myomectomy
  • History of genetic or acquired conditions altering uterine anatomy
  • History of coagulation disorders
  • History of connective tissue disorders like Lupus or Scleroderma affecting healing
  • Hemodynamically unstable before cesarean section
  • Failure to sign the informed consent form

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - Up to a few hours on the day of delivery

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person at delivery room)

Surgery and Immediate Post-operative Care

Duration - Single day (day of cesarean section)

Participants undergo cesarean section using one of four assigned surgical techniques for uterine incision and closure performed by their gynecologist.

1 surgical procedure visit (in-person)

Post-operative Follow-up

Duration - Between 6 and 16 weeks postoperatively

Participants have a transvaginal pelvic ultrasound performed to assess the uterine wall defect and its characteristics after surgery.

1 follow-up visit (in-person) with imaging evaluation

Trial Site Locations

Total: 1 location

1

Fundación Valle del Lili

Cali, Valle del Cauca Department, Colombia, 760032

Actively Recruiting

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Research Team

A

Albaro J. Nieto, M.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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Published Research Related To This Trial

The cesarean delivery scar pouch: clinical implications and diagnostic correlation between transvaginal sonography and hysteroscopy.

Cecilia Fabres, Guillermo Aviles, Carlos De La Jara...

https://pubmed.ncbi.nlm.nih.gov/12862268