NIPH Clinical Trials Search

A Study to Identify the Safest Uterine Incision Site for Cesarean Delivery

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Participants scheduled for cesarean section
Date of first enrollment	01/12/2025
Target sample size	158
Countries of recruitment
Study type	Interventional
Intervention(s)	Participants will be randomly assigned to either the Low-incision group (L group) or the High-incision group (H group). After exposing the vesicouterine peritoneal reflection during cesarean delivery, the uterine incision will be made 1 cm below the peritoneal reflection in the L group, and 3 cm above the peritoneal reflection in the H group. In both groups, the uterine myometrium will be closed with a two-layer continuous suture using VLOC-TM 90 (2-0 needle, Covidien). At 6-8 months postpartum, an examiner who is blinded to group allocation will perform sonohysterography (a procedure in which approximately 5 mL of saline is infused into the uterine cavity and the cavity is evaluated using transvaginal ultrasound) and record the measurements of the cesarean scar defect (CSD). Information related to the cesarean delivery, including operative time and blood loss, as well as CSD-associated variables, will be compared between the two groups.

Outcome(s)

Primary Outcome

Residual Myometrial Thickness (RMT)

Secondary Outcome

The depth and length of the cesarean scar defect (CSD), the rate of severe CSD formation (defined as a healing ratio RMT/AMT < 0.5), intraoperative findings (operative time, blood loss, and the thickness of the uterine wall on the corporal and cervical sides of the hysterotomy), and maternal background characteristics (maternal age at delivery, parity, gravidity, history of previous cesarean delivery, height, maternal weight at delivery, BMI, elective versus emergency cesarean section, gestational age at cesarean delivery, cervical dilatation at the time of surgery, neonatal birthweight, and presence or absence of menstruation at 6-8 months postpartum).

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender	Female
Include criteria	Age 18 years or older at the time of enrollment Scheduled to undergo cesarean delivery
Exclude criteria	Women with multiple pregnancies History of two or more previous cesarean deliveries Presence of uterine malformations Any other condition deemed inappropriate for participation by the attending physician