Pregnancy Related
Conditions
Keywords
Cesarean, Myometrium, scar thickness, niche
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: 1. 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. 2. 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. 3. 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.
Interventions
PROCEDUREUterine layers closed
Uterus closed with 1, 2 or 3 layers
DEVICESuture Type
Barbed or smooth
PROCEDUREEndometrium
Included or excluded
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Radiologist blinded to closure method
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myometrial thickness | 4 months | Residual myometrial thickness at the scar site assessed by MRI performed |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Extra sutures | Immediate | The number of extra sutures required to achieve surgeon-acceptable hemostasis |
| Niche | 4 months | Myometrial niche formation assessed by MRI performed |
| Scar ratio | 4 month | Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness by MRI |
| Blood loss | 1 day | Post-operative change in hemoglobin |
| Time for closure | Immediate | Time required for hysterotomy closure |
Contacts
Primary ContactJames A. Greenberg, MD
Backup ContactPamela A. Richtmyer
Outcome results
None listed