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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:
Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods. The methods are:
Four months after the surgery, participants will have a MRI of the pelvis to assess the scar on the uterus.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Layer Closure | Active Comparator | Single layer closure using the following technique: a. Closure of the myometrium and serosa with one (1) 0 V-Loc 90 suture on a GS-24 needle using an unlocked technique. The endometrium should be excluded. |
|
| Double Layer Closure | Active Comparator | Double layer closure using the following technique:
|
|
| Triple Layer Closure | Active Comparator | Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques:
or
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Uterine layers closed | Procedure | Uterus closed with 1, 2 or 3 layers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myometrial thickness | Residual myometrial thickness at the scar site assessed by MRI performed | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Niche | Myometrial niche formation assessed by MRI performed | 4 months |
| Scar ratio | Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness by MRI |
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Inclusion Criteria:
Exclusion Criteria:
Pregnant people having cesarean delivery
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James A. Greenberg, MD | Contact | 7819101968 | jagreenberg@bwh.harvard.edu | |
| Pamela A. Richtmyer | Contact | 857-282-5170 | prichtmyer@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| James A. Greenberg, MD | Brigham and Women's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26522861 | Result | Roberge S, Demers S, Girard M, Vikhareva O, Markey S, Chaillet N, Moore L, Paris G, Bujold E. Impact of uterine closure on residual myometrial thickness after cesarean: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):507.e1-507.e6. doi: 10.1016/j.ajog.2015.10.916. Epub 2015 Nov 11. | |
| 34146146 | Result |
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1 year after completion
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| ID | Term |
|---|---|
| C112829 | Endomet |
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Radiologist blinded to closure method
| Suture Type | Device | Barbed or smooth |
|
| Endometrium | Procedure | Included or excluded |
|
| 4 month |
| Blood loss | Post-operative change in hemoglobin | 1 day |
| Time for closure | Time required for hysterotomy closure | Immediate |
| Extra sutures | The number of extra sutures required to achieve surgeon-acceptable hemostasis | Immediate |
| Alessandri F, Evangelisti G, Centurioni MG, Gustavino C, Ferrero S, Barra F. Fishbone double-layer barbed suture in cesarean section: a help in preventing long-term obstetric sequelae? Arch Gynecol Obstet. 2021 Sep;304(3):573-576. doi: 10.1007/s00404-021-06121-8. |