The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014.
Ana Pilar Betrán, Jianfeng Ye, Anne-Beth Moller...
https://pubmed.ncbi.nlm.nih.gov/26849801Actively Recruiting
Led by Fundacion Clinica Valle del Lili · Updated on 2026-05-07
168
Participants Needed
1
Research Sites
39 weeks
Total Duration
Researchers are evaluating the effects of different surgical techniques used during a first cesarean section in pregnant women. The study aims to compare how making an incision in either the high or low segment of the uterus, combined with two different suturing methods (crossed and non-crossed hysterorrhaphy), impacts the development of defects in the uterine wall at the scar site, as well as related surgical complications. This is a single-blind, randomized trial conducted to better understand the safety and outcomes of these approaches. Participants will be randomly assigned to one of four groups: low segment hysterotomy with crossed suturing, high segment hysterotomy with crossed suturing, low segment hysterotomy with non-crossed suturing, or high segment hysterotomy with non-crossed suturing. The cesarean section will be performed by the attending gynecologist using the assigned technique, with incision and skin closure done according to the gynecologist's discretion. This procedure is followed by a single follow-up visit scheduled between 6 and 16 weeks post-surgery. During the follow-up appointment, participants will undergo a transvaginal pelvic ultrasound to detect any uterine wall defects (isthmoceles) at the scar site and to assess their size, location, and characteristics if present. Researchers will also measure various aspects of the uterine wall thickness around the defect. The study focuses on the incidence of uterine wall defects and surgical outcomes, with all care and assessments monitored throughout the process. Total participation includes the cesarean delivery and one follow-up ultrasound visit within 6 to 16 weeks after surgery.
CONDITIONS
High vs. Low Segmental Hysterotomy: Impact on Uterine Wall Defects Post-Cesarean
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - Up to a few hours on the day of delivery
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person at delivery room)
Duration - Single day (day of cesarean section)
Participants undergo cesarean section using one of four assigned surgical techniques for uterine incision and closure performed by their gynecologist.
1 surgical procedure visit (in-person)
Duration - Between 6 and 16 weeks postoperatively
Participants have a transvaginal pelvic ultrasound performed to assess the uterine wall defect and its characteristics after surgery.
1 follow-up visit (in-person) with imaging evaluation
Total: 1 location
1
Fundación Valle del Lili
Cali, Valle del Cauca Department, Colombia, 760032
Actively Recruiting
A
Albaro J. Nieto, M.D.
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
4
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