Cesarean-scar Thickness and Closure Technique

Christian Bamberg

Status: Completed

Conditions: Uterine Scar Remodeling

Treatments: Procedure: cesarean section technique

Study type: Interventional

Funder types: Other

Identifiers

NCT02338388

(EA1/149/11)

Details and patient eligibility

About

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

Full 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.

Enrollment: 435 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Elective cesarean section
• Cesarean section during labor

Exclusion criteria

• Emergency cesarean section
• Declined to participate

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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435 participants in 3 patient groups

Single-layer unlocked closure

Active Comparator group

Treatment:

Procedure: cesarean section technique

Single-layer locked closure

Active Comparator group

Treatment:

Procedure: cesarean section technique

Double-layer closure

Active Comparator group

Description:

The first layer was continuous and unlocked and a second, continuous non-locking imbricating layer was applied over the first suture.

Treatment:

Procedure: cesarean section technique