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

Not Applicable

• Conditions: Myometrial Thickness; Cesarean Section; Transvaginal Ultrasound; Uterine Scar Deficiency; Single-layer Continuous Uterotomy Suture; Double-layer Continuous Uterotomy Suture
• Interventions: Procedure: uterine closure during cesarean section

• Registration Number: NCT03039803
• Lead Sponsor: Medical University of Vienna

Brief 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-27
• Study Start: 2017-01
• Study First Submitted QC: 2017-01-30
• Study First Posted: 2017-02-01
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-22
• Last Update Posted: 2018-08-23
• Primary Completion: 2019-09
• Study Completion: 2019-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• First cesarean section
• Scheduled cesarean section at Department of Obstetrics and Gynecology, Medical University of Vienna
• Age ≥ 18 years
• Informed Consent
• Cesarean section at ≥ 37+0 weeks of gestation

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Exclusion Criteria

• Previous cesarean section
• Emergency cesarean section
• Cesarean section < 37+0 weeks of gestation
• Corporal incision during cesarean section
• Diseases which favor wound healing disruptions (e.g. chronic inflammatory diseases)
• Uterine anatomic anomalies
• BMI > 35kg/m2
• Placenta previa

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single-layer continuous uterotomy suture	uterine closure during cesarean section	Single-layer continuous uterotomy suture
double-layer continuous uterotomy suture	uterine closure during cesarean section	double-layer continuous uterotomy suture

Primary Outcome Measures

Name	Time	Method
Cesarean section (CS) scar deficiency visualized in transvaginal ultrasound at 3 months after CS (yes/no).	3 months

Secondary Outcome Measures

Name	Time	Method
Myometrial thickness at the site of uterine scar (mm).	3 months

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria