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

NCT06620432 | Recruiting DMC

• 1 other identifier: 2024.079
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

High segmental hysterotomy; Low segmental hysterotomy; Caesarean section; hysterotomy defects

Outcome Measures

Primary Outcomes (1)

• Incidence of uterine wall defect at the scar site

  Performed via transvaginal ultrasound by a gynecologist trained in ultrasound who is blinded to the intervention

  6 to 16 weeks post-hysterotomy

Secondary Outcomes (5)

• Residual myometrial thickness of the uterine wall defect at the scar site

  6 to 16 weeks post-hysterotomy

• Myometrial thickness in the portion immediately cephalad to the residual myometrial defect

  6 to 16 weeks post-hysterotomy

• Myometrial thickness in the portion immediately caudal to the residual myometrial defect

  6 to 16 weeks post-hysterotomy

• Size of the uterine wall defect

  6 to 16 weeks post-hysterotomy

• Depth of the defect in the uterine wall

  6 to 16 weeks post-hysterotomy

Study Arms (4)

Low Segment Hysterotomy + Crossed hysterorrhaphy

ACTIVE COMPARATOR

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; Procedure: Crossed hysterorrhaphy

High Segment Hysterotomy + Crossed hysterorrhaphy

EXPERIMENTAL

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: High segment hysterotomy; Procedure: Crossed hysterorrhaphy

Low Segment Hysterotomy + Non-Crossed hysterorrhaphy

EXPERIMENTAL

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; Procedure: Non-Crossed hysterorrhaphy

High Segment Hysterotomy + Non-Crossed hysterorrhaphy

EXPERIMENTAL

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; Procedure: Non-Crossed hysterorrhaphy

Interventions

Low segment hysterotomy PROCEDURE

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.

Low Segment Hysterotomy + Crossed hysterorrhaphy; Low Segment Hysterotomy + Non-Crossed hysterorrhaphy

High segment hysterotomy PROCEDURE

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

High Segment Hysterotomy + Crossed hysterorrhaphy; High Segment Hysterotomy + Non-Crossed hysterorrhaphy

Crossed hysterorrhaphy PROCEDURE

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.

High Segment Hysterotomy + Crossed hysterorrhaphy; Low Segment Hysterotomy + Crossed hysterorrhaphy

Non-Crossed hysterorrhaphy PROCEDURE

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

High Segment Hysterotomy + Non-Crossed hysterorrhaphy; Low Segment Hysterotomy + Non-Crossed hysterorrhaphy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacion Clinica Valle del Lili: lead

Study Sites (1)

Fundación Valle del Lili

Cali, Valle del Cauca Department, 760032, Colombia

RECRUITING

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MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Albaro J. Nieto, M.D.

  Fundacion Clinica Valle del Lili

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Albaro J. Nieto, M.D.

CONTACT

3319090; albaro.nieto@fvl.org.co

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: October 1, 2024
• Study Start: June 12, 2025
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): August 31, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)