Clinical trial NCT06620432: High Vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean
Official title: High Segmental Hysterotomy Vs. Low Segmental Hysterotomy: Association with the Incidence of Uterine Wall Defects After Cesarean Section
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Placenta Accreta Spectrum
Keywords: High segmental hysterotomy
Low segmental hysterotomy
Caesarean section
hysterotomy defects
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2024-10-01
Enrollment: 168
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of uterine wall defect at the scar site
timeFrame: 6 to 16 weeks post-hysterotomy
Secondary outcomes:
measure: Residual myometrial thickness of the uterine wall defect at the scar site
timeFrame: 6 to 16 weeks post-hysterotomy
measure: Myometrial thickness in the portion immediately cephalad to the residual myometrial defect
timeFrame: 6 to 16 weeks post-hysterotomy
measure: Myometrial thickness in the portion immediately caudal to the residual myometrial defect
timeFrame: 6 to 16 weeks post-hysterotomy
measure: Size of the uterine wall defect
timeFrame: 6 to 16 weeks post-hysterotomy
measure: Depth of the defect in the uterine wall
timeFrame: 6 to 16 weeks post-hysterotomy
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundación Valle del Lili
state: Valle del cauca
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Albaro J. Nieto, M.D.
role: PRINCIPAL_INVESTIGATOR
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