Preventing Isthmocele After Cesarean Section

Summary

Cesarean section accounts for nearly 30% of births in Canada, and is the most commonly performed surgery by Obstetrician Gynecologists. Cesarean scar isthmocele, meaning a defect in the uterine wall at the site of a previous uterine incision, is a common complication of this surgery. While most are likely asymptomatic, isthmoceles can lead to major complications in pregnancy (uterine rupture, invasive placentation, cesarean scar ectopic pregnancy) and outside of pregnancy (abnormal uterine bleeding, infertility and pain). Studies have shown that the method used to suture the uterus at the time of a cesarean section may have an impact on the incidence of post-operative isthmocele formation. Our study is a randomized control trial of the impact of locked vs unlocked uterine closure at cesarean section on the incidence of isthmocele formation. Women undergoing cesarean section will be randomized to have either a locked or unlocked uterine closure. They will then return 6 months after their surgery for a transvaginal ultrasound to evaluate the presence or absence of an isthmocele.

This study is a pilot trial. The investigators hope to determine the feasibility of completing a large randomized control trial by recording: a) the number of patient who agree to participate in this study, b) the number of patients who receive the correct intervention and, c) the number of patients who return for their post operative ultrasound.

The investigators also plan to assess multiple secondary outcomes. First, the goal is to determine the isthmocele incidence within the study subjects of the pilot trial in order to perform a power calculation for a subsequent larger trial in this area. Another goal is to determine if the uterine closure techniques in this study lead to differences in surgical time, blood loss or the need for intra- or post-operative blood transfusion. Last, the study will collect data on the suture material most commonly used in this study to determine if this requires standardization in the subsequent larger trial.

Conditions

• Cesarean Section Complications
• Uterine Scar Diverticulum
• Uterine Scar From Previous Cesarean Delivery

Interventions

PROCEDURE

Non-Locking Uterine Closure

The first layer of the two-layer uterine closure will be sutured with a running \& non-locking technique. The second layer cannot be of a locking technique.

PROCEDURE

Locked Uterine Closure

The first layer of the two-layer uterine closure will be sutured with a running \& locking technique. The second layer can be locking or non-locking.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada

  lead OTHER

Principal Investigators

• Mara Sobel, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-03-05

Primary Completion

2020-12-18

Completion

2020-12-18

Countries

• Canada

Study Locations