Preventing Isthmocele After Cesarean Section

NCT03826459 | Completed

• 1 other identifier: PICS
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• Number of Participants Enrolled

  Number of potential participants approached who actually enrolled in the trial

  6 months

• Number of Participants that Cross-Over

  Number of participants who cross-over to the other study arm (i.e. who receive the incorrect uterine closure technique)

  6 months

• Number of Participants Lost to Follow Up

  Number of participants enrolled in the trial who do not present for their follow up ultrasound at 6 months.

  6 months

Secondary Outcomes (11)

• Incidence of Isthmocele

  6 months

• Estimated Blood Loss

  Through surgery completion (estimated 1 hour)

• Change in Hemoglobin

  24 hours

• Operative Time

  Through surgery completion (estimated 1 hour)

• Number of Blood Transfusions

  Throughout hospital stay (estimated 48 hours)

Study Arms (2)

Locked Uterine Closure

ACTIVE COMPARATOR

Participants will undergo two-layer closure of the hysterotomy site at the time of cesarean section. The first layer will use a running \& locking technique. The second layer will be performed based on surgeon preference.

Procedure: Locked Uterine Closure

Non-Locking Uterine Closure

EXPERIMENTAL

Participants will undergo two-layer closure of the hysterotomy site at the time of cesarean section. The first layer will use a running \& non-locking technique. The second layer will be performed based on surgeon preference, but cannot be of a locking technique.

Procedure: Non-Locking Uterine Closure

Interventions

Non-Locking Uterine Closure PROCEDURE

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.

Non-Locking Uterine Closure

Locked Uterine Closure PROCEDURE

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.

Locked Uterine Closure

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Since this is a study done at the time of cesarean section, only females are eligible.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing their first cesarean section

You may not qualify if:

• previous uterine hysterotomy (caesarean section, myomectomy, etc.)
• known uterine anomalies
• active labour
• known bleeding disorder
• maternal connective tissue disorders

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1Z5, Canada

Location

Related Publications (1)

• Warshafsky C, Kirubarajan A, Chaikof M, Stere A, Chudawala U, Li Q, Huszti E, Mohamed D, Abdalla MH, Hartman A, Sanders A, Murji A, Sobel M. Preventing Isthmocele After Cesarean Section (PICS): A Pilot Randomized Controlled Trial. J Obstet Gynaecol Can. 2022 Nov;44(11):1134-1135. doi: 10.1016/j.jogc.2022.08.003. Epub 2022 Aug 12. No abstract available.

  PMID: 35970439 DERIVED

Study Officials

• Mara Sobel, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstetrician/Gynecologist

Model Details: Participants will be randomized to either locked or non-locked uterine closure at the time of cesarean section.

Study Record Dates

• First Submitted: January 28, 2019
• First Posted: February 1, 2019
• Study Start: March 5, 2019
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: January 25, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)