At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Decidual-Sparing Two-Layered Simple Interrupted Myometrial Suturing With Visceral Peritoneal Closure Reduces Uterine Niche Formation After Primary Cesarean Section: A Randomized Controlled Trial
In Brief
A clinical study evaluating Primary Cesarean Section with two-layered simple interrupted suturing of the myometrium, Primary Cesarean Section with double-layered continuous suturing of the myometrium, and 1 other intervention for Cesarean Section Complications and 3 related conditions. Completed, enrolled 380 participants across 1 site.
Detailed Summary
The purpose of the study is to determine whether two-layered simple interrupted myometrial suturing is superior to double-layered continuous suturing for the prevention of uterine niche formation after primary cesarean section.
Study Details
Timeline
Interventions
All steps of cesarean section were standardized for both arms except for the type of myometrial suturing where two-layered simple interrupted suturing of the myometrium was applied.
All steps of cesarean section were standardized for both arms except for the type of myometrial suturing where double-layered continuous suturing of the myometrium was applied.
At 6 months postpartum, all patients were evaluated by a single blinded sonographer experienced in niche assessment. First, transvaginal ultrasound was performed to exclude pregnancy or pelvic pathology, followed by saline-infusion sonohysterography (2D, sagittal and coronal views). A niche was defined as ≥ 2 mm myometrial indentation at the scar site. Niche depth, length, width, and residual myometrial thickness were recorded.