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

Fundacion Clinica Valle del Lili

Status: Not yet enrolling

Conditions: Placenta Accreta Spectrum

Treatments: Procedure: Crossed hysterorrhaphy; Procedure: High segment hysterotomy; Procedure: Non-Crossed hysterorrhaphy; Procedure: Low segment hysterotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06620432

2024.079

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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168 participants in 4 patient groups

Low Segment Hysterotomy + Crossed hysterorrhaphy

Active Comparator group

Description:

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.

Treatment:

Procedure: Low segment hysterotomy

Procedure: Crossed hysterorrhaphy

High Segment Hysterotomy + Crossed hysterorrhaphy

Experimental group

Description:

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.

Treatment:

Procedure: High segment hysterotomy

Procedure: Crossed hysterorrhaphy

Low Segment Hysterotomy + Non-Crossed hysterorrhaphy

Experimental group

Description:

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.

Treatment:

Procedure: Low segment hysterotomy

Procedure: Non-Crossed hysterorrhaphy

High Segment Hysterotomy + Non-Crossed hysterorrhaphy

Experimental group

Description:

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.

Treatment:

Procedure: Non-Crossed hysterorrhaphy

Procedure: High segment hysterotomy