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

May 5, 2026 updated by: Fundacion Clinica Valle del Lili

High Segmental Hysterotomy vs. Low Segmental Hysterotomy: Association With the Incidence of Uterine Wall Defects After Cesarean Section

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be conducted as a single-blind trial. Patients will be approached in the delivery room, where a comprehensive review of the inclusion and exclusion criteria checklist will be conducted to determine their eligibility for the study. Once eligible patients are identified, the study will be thoroughly explained to them, highlighting its purpose, potential benefits, and risks. This will be followed by a detailed discussion of the informed consent form to ensure that participants fully understand what their involvement entails.

Upon obtaining informed consent, a randomization process will be implemented to allocate participants to one of the four study arms. The assigned procedure will be performed by their attending gynecologist, who is familiar with their medical history and care needs. Throughout the study, various outcomes will be measured, including intraoperative findings, postoperative recovery, and post-discharge progress.

A transvaginal pelvic ultrasound will be ordered to be performed between 6 and 16 weeks postoperatively. During the single follow-up appointment, this imaging evaluation will be carried out to determine the presence or absence of an isthmocele, as well as to assess its characteristics, such as size and location, if present.

Study Type

Interventional

Enrollment (Estimated)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Colombia
    • Valle del Cauca Department
      • Cali, Valle del Cauca Department, Colombia, 760032
        • Recruiting
        • Fundacion Valle del Lili
        • Contact:
        • Sub-Investigator:
          • José M. Palacios, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Low Segment Hysterotomy + Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
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.
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.
Experimental: Low Segment Hysterotomy + Non-Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of Low Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
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.
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
Experimental: High Segment Hysterotomy + Non-Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Non-Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
Procedure: High segment hysterotomy
A high segment hysterotomy is a surgical procedure involving an incision in the upper segment of the uterus.
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
Experimental: High Segment Hysterotomy + Crossed hysterorrhaphy
The participant will undergo a cesarean section in which the surgical technique of High Segment Hysterotomy and Crossed hysterorrhaphy for uterine closure will be employed. The initial incision and skin closure will be performed at the discretion of the gynecologist.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of uterine wall defect at the scar site
Time Frame: 6 to 16 weeks post-hysterotomy
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
6 to 16 weeks post-hysterotomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Residual myometrial thickness of the uterine wall defect at the scar site
Time Frame: 6 to 16 weeks post-hysterotomy
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
6 to 16 weeks post-hysterotomy
Myometrial thickness in the portion immediately cephalad to the residual myometrial defect
Time Frame: 6 to 16 weeks post-hysterotomy
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
6 to 16 weeks post-hysterotomy
Myometrial thickness in the portion immediately caudal to the residual myometrial defect
Time Frame: 6 to 16 weeks post-hysterotomy
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
6 to 16 weeks post-hysterotomy
Size of the uterine wall defect
Time Frame: 6 to 16 weeks post-hysterotomy
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
6 to 16 weeks post-hysterotomy
Depth of the defect in the uterine wall
Time Frame: 6 to 16 weeks post-hysterotomy
Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention
6 to 16 weeks post-hysterotomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinica Valle del Lili

Investigators

  • Principal Investigator: Albaro J. Nieto, M.D., Fundacion Clinica Valle del Lili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 12, 2025

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

August 26, 2024

First Submitted That Met QC Criteria

September 27, 2024

First Posted (Actual)

October 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024.079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data (IPD) will be shared, as disclosure of information related to the medical history of participants or health care workers is not permitted under applicable regulations.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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