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

N/ARecruitingNCT06620432

Fundacion Clinica Valle del Lili168 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

Interventions

Low segment hysterotomyPROCEDURE

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.

High segment hysterotomyPROCEDURE

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

Crossed hysterorrhaphyPROCEDURE

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.

Non-Crossed hysterorrhaphyPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.