Cesarean-scar Thickness and Closure Technique

Longitudinal Transvaginal Ultrasound Evaluation of Cesarean-scar Thickness in the First Two Years After Single- or Double-layer Uterotomy Closure: a Prospective Randomized Study

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

Study Overview

• Status: Completed
• Conditions: Uterine Scar Remodeling
• Intervention / Treatment: Procedure: cesarean section 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 Type: Interventional
• Enrollment (Actual): 435
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Elective cesarean section
• Cesarean section during labor

Exclusion Criteria:

• Emergency cesarean section
• Declined to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single-layer unlocked closure	Procedure: cesarean section technique; Comparing three different types of suturing the uterus at Cesarea section
Active Comparator: Single-layer locked closure	Procedure: cesarean section technique; Comparing three different types of suturing the uterus at Cesarea section
Active Comparator: Double-layer closure; The first layer was continuous and unlocked and a second, continuous non-locking imbricating layer was applied over the first suture.	Procedure: cesarean section technique; Comparing three different types of suturing the uterus at Cesarea section

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cesarean scar-thickness	24 months

Collaborators and Investigators

• Sponsor: Christian Bamberg

Publications and helpful links

General Publications

• Bamberg C, Hinkson L, Dudenhausen JW, Bujak V, Kalache KD, Henrich W. Longitudinal transvaginal ultrasound evaluation of cesarean scar niche incidence and depth in the first two years after single- or double-layer uterotomy closure: a randomized controlled trial. Acta Obstet Gynecol Scand. 2017 Dec;96(12):1484-1489. doi: 10.1111/aogs.13213. Epub 2017 Sep 21.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: January 12, 2015
• First Submitted That Met QC Criteria: January 12, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Estimate): January 15, 2015
• Last Update Submitted That Met QC Criteria: January 13, 2015
• Last Verified: January 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: (EA1/149/11)