Clinical trial NCT05750394: Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
Official title: Cesarean 123 Trial: Prospective Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: Cesarean
Myometrium
scar thickness
niche
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-03-01
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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\^2

Exclusion Criteria:

* More than 1 prior cesarean delivery
* Multiple gestation
* Known coagulation disorder or current use of anti-coagulants
* Mullerian anomalies
* Placenta previa

Primary outcomes:
measure: Myometrial thickness
timeFrame: 4 months
Secondary outcomes:
measure: Niche
timeFrame: 4 months
measure: Scar ratio
timeFrame: 4 month
measure: Blood loss
timeFrame: 1 day
measure: Time for closure
timeFrame: Immediate
measure: Extra sutures
timeFrame: Immediate
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: James A. Greenberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.