- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05750394
제왕절개 123 시험: 제왕절개 분만 중 단일, 이중 및 삼중 자궁 폐쇄를 비교하는 무작위 시험 (C123T)
제왕절개 123 시험: 제왕절개 분만 중 단일, 이중 및 삼중 자궁 폐쇄를 비교하는 전향적 무작위 시험
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.
연구 개요
연구 유형
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Single Layer Closure
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. |
Uterus closed with 1, 2 or 3 layers Barbed or smooth Included or excluded |
|
활성 비교기: Double Layer Closure
Double layer closure using the following technique:
|
Uterus closed with 1, 2 or 3 layers Barbed or smooth Included or excluded |
|
활성 비교기: Triple Layer Closure
Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques:
or
|
Uterus closed with 1, 2 or 3 layers Barbed or smooth Included or excluded |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Myometrial thickness
기간: 4 months
|
Residual myometrial thickness at the scar site assessed by MRI performed |
4 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Niche
기간: 4 months
|
Myometrial niche formation assessed by MRI performed |
4 months
|
|
Scar ratio
기간: 4 month
|
Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness by MRI |
4 month
|
|
Blood loss
기간: 1 day
|
Post-operative change in hemoglobin |
1 day
|
|
Time for closure
기간: Immediate
|
Time required for hysterotomy closure |
Immediate
|
|
Extra sutures
기간: Immediate
|
The number of extra sutures required to achieve surgeon-acceptable hemostasis |
Immediate
|
공동 작업자 및 조사자
수사관
- 수석 연구원: James A. Greenberg, MD, Brigham and Women's Hospital
간행물 및 유용한 링크
일반 간행물
- 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.
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .