Comparing single-layer and double-layer uterine closure techniques during cesarean delivery
Single Versus Double-layer Closure of The Cesarean Scar In Niche Development: A Randomized Clinical Trial
This study is testing whether closing the uterus with one layer or two layers during a cesarean delivery can affect the chances of developing complications later on for pregnant women having their first cesarean.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 938 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | Hanoi Obstetrics and Gynecology Hospital Academic / other |
| Locations | 1 site (Hanoi, Hanoi) |
| Trial ID | NCT05312775 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the impact of different uterine closure techniques on the formation of cesarean scar defects, known as niches, and associated gynecological complications. Pregnant women at term who are undergoing their first cesarean delivery will be randomly assigned to receive either single-layer or double-layer closure. The study will utilize a double-blinded, single-center design, with participants and sonographers unaware of the closure technique used. The outcomes will be assessed through transvaginal ultrasound and follow-up consultations.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older, at gestational age of 37 weeks or more, who are undergoing their first cesarean delivery.
Not a fit: Patients with a history of major uterine surgery or current pregnancy complications such as abnormal placenta will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help determine the optimal uterine closure technique to reduce complications related to cesarean deliveries.
How similar studies have performed: While there is limited literature on this specific comparison, similar studies have explored uterine closure techniques, indicating potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pregnant women who undergo a primary CD (planned or unplanned) * Age ≥ 18 years. * Gestational age ≥ 37 0/7 weeks Exclusion Criteria: * Previous major uterine surgery (e.g. laparoscopic or laparotomic fibroid resection, septum resection). * Women with abnormal menstrual bleeding (e.g. cervical dysplasia, communicating hydrosalpinx, uterine anomaly or endocrine disorders disturbing ovulation, drugs, polyps, fibroids, etc.). * Women with dysmenorrhea, dyspareunia, suprapubic pain. * Abnormal placenta: Placenta privia, Placenta percreta… in the current pregnancy.
Where this trial is running
Hanoi, Hanoi
- Hanoi Obstetrics and Gynecology Hospital — Hanoi, Hanoi, Vietnam (Recruiting)
Study contacts
- Principal investigator: Ha TT Nguyen, PhD.MD — Hanoi Obstetric and Gynecology Hospital
- Study coordinator: Ha TT Nguyen, PhD.MD
- Email: dr.hanguyen@hogh.vn
- Phone: 0989661093
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.