Cesarean 123 Trial: Prospective Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 120
- Primary Endpoint
- Myometrial thickness
Study Overview
Brief Summary
The goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods. The main questions it aims to answer are:
- Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure
- Myometrial niche formation assessed by MRI performed 4 months after the procedure
- Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness
- Post-operative change in hemoglobin
- Time required for hysterotomy closure
- The number of extra sutures required to achieve surgeon-acceptable hemostasis
Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods. The methods are:
- Single layer closure using the following technique: Closure of the myometrium and serosa with one barbed suture using a running unlocked technique. The endometrium should be excluded.
- Double layer closure using the following technique: Closure of the full thickness of the myometrium with one smooth suture using a running locked technique. The endometrium should be excluded. Followed by imbrication of the second layer with one smooth suture using a running unlocked technique.
- Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique. Or, Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique.
Four months after the surgery, participants will have a MRI of the pelvis to assess the scar on the uterus.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Radiologist blinded to closure method
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •18 years or older
- •Singleton gestation
- •Nonurgent primary or secondary cesarean delivery at greater than 35w6d
- •Body Mass Index (BMI) <35 kg/m^2
Exclusion Criteria
- •More than 1 prior cesarean delivery
- •Multiple gestation
- •Known coagulation disorder or current use of anti-coagulants
- •Mullerian anomalies
- •Placenta previa
Outcomes
Primary Outcomes
Myometrial thickness
Time Frame: 4 months
Residual myometrial thickness at the scar site assessed by MRI performed
Secondary Outcomes
- Niche(4 months)
- Scar ratio(4 month)
- Blood loss(1 day)
- Extra sutures(Immediate)
- Time for closure(Immediate)
Investigators
James Greenberg, MD
Vice Chair OB/GYN
Brigham and Women's Hospital
