Cesarean-scar Thickness and Closure Technique

Not Applicable

Completed

• Conditions: Uterine Scar Remodeling
• Interventions: Procedure: cesarean section technique

• Registration Number: NCT02338388
• Lead Sponsor: Christian Bamberg

Brief Summary

The aim of this trial is the surgical method in cesarean deliveries, especially the uterotomy closure technique.

Detailed Description

The aim of this prospective, randomized controlled trial was to longitudinally evaluate uterine-scar remodeling via transvaginal ultrasound after single- or double-layer uterine closure six weeks and at least six months after Cesarean delivery.

The women were included at their booking visit for an elective CD or during labor before an nonemergent CD. They were randomly assigned for three different uterotomy suture techniques: The uterus was closed with a continuous single layer locked stitch or continuous single unlocked layer or double layer.

Six weeks and between six and twenty-four month after their cesarean delivery the women were examined by transvaginal ultrasound with an empty maternal bladder, in a supine decubitus position using a GE E8 system equipped with a 5-9 MHz transducer (GE Healthcare, Milwaukee, WI).

The measurement of the uterine scar thickness was performed perpendicular to the uterine wall and was defined as shortest visible distance between the decidua and the delineation of the endometrium at the level of the cesarean scar.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Status Verified: 2015-01
• Study First Submitted: 2015-01-12
• Study First Submitted QC: 2015-01-12
• Last Update Submitted: 2015-01-13
• Study First Posted: 2015-01-14
• Last Update Posted: 2015-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 435

Inclusion Criteria

• Elective cesarean section
• Cesarean section during labor

Exclusion Criteria

• Emergency cesarean section
• Declined to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Single-layer unlocked closure	cesarean section technique	-
Single-layer locked closure	cesarean section technique	-
Double-layer closure	cesarean section technique	The first layer was continuous and unlocked and a second, continuous non-locking imbricating layer was applied over the first suture.

Primary Outcome Measures

Name	Time	Method
cesarean scar-thickness	24 months