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Clinical Research Directory

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Cesarean Scar Defect (Isthmococele)

Tundra lists 2 Cesarean Scar Defect (Isthmococele) clinical trials. Each listing includes eligibility criteria, study locations, and direct links to research sites in the Tundra directory.

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COMPLETED

NCT07611331

Single-Layer Versus Double-Layer Uterine Closure After Primary Cesarean Section

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

Gender: FEMALE

Ages: 18 Years - 45 Years

Updated: 2026-05-28

1 state

Cesarean Scar Defect (Isthmococele)
Pelvic Pain
Spotting
+2
RECRUITING

NCT07323355

Single- vs Double-Layer Cesarean Scar Repair and Myometrial Thickness

Cesarean delivery (CD) is one of the most commonly performed surgical procedures worldwide, with a rising incidence particularly in high-income countries. Although often life-saving, cesarean delivery carries both short- and long-term maternal risks. Early complications include infection, hemorrhage, and thromboembolism, while inadequate uterine healing can lead to future complications such as uterine rupture and placenta accreta spectrum disorders. Additionally, cesarean scars may result in pregnancy complications, isthmocele formation, postmenstrual bleeding, pelvic pain, and dysmenorrhea. This highlights the need for optimization of the surgical technique. Despite increasing cesarean rates, there is no consensus on the optimal uterine closure method. Techniques vary in terms of the number of layers, suture locking style, and inclusion of the endometrium, and their comparative effectiveness in reducing scar defects remains unclear. Some previous studies have reported increased uterine rupture risk with single-layer locked sutures and better healing with double-layer closure, while others found no significant difference in scar outcomes. This study aims to investigate the effects of single- versus double-layer cesarean scar closure on myometrial thickness and its clinical implications.

Gender: FEMALE

Ages: 18 Years - 44 Years

Updated: 2026-01-07

1 state

Caesarean Section
Cesarean Scar Closure
Cesarean Scar Defect (Isthmococele)
+3