NCT03039803

Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency

Impact of Double-layer Versus Single-layer Uterine Closure Suture in Cesarean Section on the Development of Postoperative Uterine Scar Deficiency: A Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

In recent decades, the rate of cesarean section delivery has steadily increased worldwide ranging at 30% of deliveries, thus long-term risks after cesarean section need to be evaluated. Postoperative risks include, among others, uterine scar rupture and placental complications such as placenta previa and accreta- complications, which are possibly associated with uterine scar dehiscence. The prevalence of lower-segment uterine scar deficiency has previously been described as 63%. One recent systematic review and meta analysis investigated closure techniques of low transverse cesarean. No significant difference in risk of uterine scar defect comparing single layer versus double layer closure could be detected (RR 0.53), whereas in women with single layer closure, a lower residual myo-metrial thickness was observed (-2.6mm). However, the authors do conclude that data is insufficient to determine the risk of uterine rupture, dehiscence or gynecological outcomes due to insufficient power of available studies. A recently published Randomized Controlled Trial concluded that double-layer closure with unlocked first layer showed a better scar healing than locked single layer. The investigators main objective is to identify if single-layer suture of the uterus during cesarean section results in a higher rate of cesarean scar deficiency than double-layer suture. Interventions Single- layer versus double- layer uterine closure Two different techniques of uterine closure in cesarean section will be compared: single- layer versus double- layer continuous uterotomy suture. Standardized transvaginal sonography Transvaginal ultrasound examination is carried out by one expert sonographer. The ultrasound machine used for all examinations is GE Voluson E10. Primary outcome: CS scar deficiency visualized in transvaginal ultrasound at 3 months after CS (yes/no). Secondary outcome: Myometrial thickness at the site of uterine scar (mm).

Conditions

• Cesarean Section
• Uterine Scar Deficiency
• Myometrial Thickness
• Single-layer Continuous Uterotomy Suture
• Double-layer Continuous Uterotomy Suture
• Transvaginal Ultrasound

Interventions

Type	Name	Description
PROCEDURE	uterine closure during cesarean section

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2017-02-01
• Last updated: 2018-08-23

Locations

1 site across 1 country: Austria