Single-Layer Versus Double-Layer Uterine Closure After Primary Cesarean Section (NCT07611331) | Clinical Trial Compass
CompletedNot Applicable
Single-Layer Versus Double-Layer Uterine Closure After Primary Cesarean Section
Tunisia384 participantsStarted 2025-01-01
Plain-language summary
This study compares two surgical techniques for closing the uterus after cesarean section: single-layer versus double-layer closure. The primary objective is to determine which technique results in better uterine scar healing, measured by residual myometrial thickness (RMT) and cesarean scar defect (niche) prevalence at 6 weeks and 6 months postoperatively.
BACKGROUND:
Cesarean section is one of the most common surgeries worldwide. After fetal delivery, the uterine incision must be closed by suture. Poor scar healing can lead to niche formation, abnormal bleeding, pelvic pain, dyspareunia, and complications in future pregnancies including uterine rupture and placenta accreta.
INTERVENTION:
Participants are randomized 1:1 to receive either:
* Single-layer closure: one continuous non-locking suture through full myometrial thickness
* Double-layer closure: two successive extra-mucosal non-locking sutures excluding the decidua
ASSESSMENTS:
Transvaginal ultrasound at 6 weeks and 6 months measures RMT and niche presence. Standardized symptom questionnaires assess pelvic pain, spotting, dysmenorrhea, and dyspareunia.
ELIGIBILITY:
Women aged 18-45 years undergoing primary cesarean section with singleton pregnancy at term (gestational age ≥ 37 weeks).
ENROLLMENT: 384 participants (192 per group)
SETTING: Department of Obstetrics and Gynecology, Hedi Chaker University Hospital, Sfax, Tunisia
FOLLOW-UP: 6 months per participant in which the patients attend 2 follow-up visits:
First visit 6 weeks after surgery. Second visit at 6 months after surgery
.And have a pelvic ultrasound at each visit
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women aged 18 years or older
* Singleton pregnancy
* Gestational age ≥ 37 weeks (term pregnancy)
* Scheduled or emergency primary cesarean section (first cesarean delivery, no previous uterine scar)
* Low transverse uterine incision (Pfannenstiel or Joel-Cohen approach)
* Ability to provide written informed consent
* Willingness to attend follow-up visits at 6 weeks and 6 months postoperatively
* Patient affiliated to a social security system or equivalent healthcare coverage
Exclusion Criteria:
* Previous uterine surgery (prior cesarean section, myomectomy, uterine perforation, or any procedure leaving a uterine scar)
* Multiple pregnancy (twins or higher-order multiples)
* Preterm delivery (gestational age \< 37 weeks)
* Classical (vertical) or inverted T uterine incision
* Placenta previa or placenta accreta spectrum disorder
* Active uterine infection or chorioamnionitis at time of surgery
* Coagulation disorders or anticoagulant therapy
* Immunosuppressive therapy or conditions affecting wound healing (systemic corticosteroids, immunosuppressants)
* Severe maternal comorbidities (uncontrolled diabetes, connective tissue disorders, chronic renal failure)
* Participation in another interventional clinical trial
* Patient unable to attend scheduled follow-up visits
* Patient unable to understand or sign informed consent
* Fetal demise or major fetal malformation
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Residual Myometrial Thickness (RMT) at the Cesarean Scar at 6 Weeks and 6 Months
Timeframe: 6 weeks and 6 months after cesarean section
2
Prevalence of Cesarean Scar Defect (Niche) at 6 Weeks and 6 Months Postoperatively
Timeframe: 6 weeks and 6 months after cesarean section