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NCT05750394
Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
Conditions: Pregnancy Related
Sex: Female
Ages: 18 Years – 50 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 120
Sponsor: Brigham and Women's Hospital
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 procedureMyometrial niche formation assessed by MRI performed 4 months after the procedureScar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thicknessPost-operative change in hemoglobinTime required for hysterotomy closureThe number of extra sutures required to achieve surgeon-acceptable hemostasisParticipants 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.
Eligibility Criteria
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^2Exclusion Criteria:More than 1 prior cesarean delivery Multiple gestation Known coagulation disorder or current use of anti-coagulants Mullerian anomalies Placenta previa
Source: ClinicalTrials.gov (NCT05750394). StuddyBuddy aggregates publicly available trial information.