선택적 제왕절개 분만에서 방광 카테터 삽입의 사용과 비사용
선택적 제왕절개 분만 시 방광 카테터 사용 여부에 대한 무작위 대조 시험
The goal of this randomized controlled trial is to investigate the impact of routine bladder catheterization in uncomplicated cesarean sections on time to ambulation, time to discharge, urinary retention, development of urinary tract infections, prevention of bladder injury, operating time, and patient satisfaction.
연구 개요
상세 설명
This would be a randomized controlled trial conducted on the labour and delivery and post-partum unit at a large academic site (Foothills Medical Centre) in Calgary, Alberta. Study recruitment of patients awaiting delivery via CS would occur either in participating prenatal clinics in Calgary or in obstetrical triage by a trained nurse research assistant. Participants would be randomized into either a catheterized or non-catheterized group prior to their scheduled elective CS. Allocation concealment will be ensured by using either a central computer generator for randomization if funding permits, otherwise sealed, opaque, and sequenced envelopes will be used. Since there may be potential differences in patients with increasing parity, randomization will be stratified by parity and blocked to prevent imbalance in treatment groups.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
Alberta
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Calgary, Alberta, 캐나다, T2N 2T9
- University of Calgary
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion criteria:
- women who are 18 years of age or older with a singleton pregnancy presenting for an elective primary or repeat CS.
Exclusion criteria:
- diagnosis of abnormal placentation including placenta previa, vasa previa, or suspected invasive disease
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Bladder catheterization
Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post Cesarean section. |
Patients placed in the catheterized group will have an indwelling catheter placed after anesthetic has been administered. It would be removed at 12 hours post cesarean section. |
|
간섭 없음: Non-use of bladder catheterization
Participants in the non-catheterized group would be encouraged to empty their bladders just prior to transfer to the operating room where they will undergo surgery without an indwelling catheter. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Time to ambulation
기간: Prior to discharge, assessed up to 3 days postpartum
|
Time to ambulation will be collected via a form that will be distributed by the postpartum nursing team. |
Prior to discharge, assessed up to 3 days postpartum
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Incidence of urinary retention
기간: Prior to discharge, assessed up to 3 days postpartum
|
Urinary retention will be defined based on a patient's inability to spontaneously void requiring either in-and-out catheterization or placement of an indwelling catheter during the post operative course |
Prior to discharge, assessed up to 3 days postpartum
|
|
Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum
기간: first 4 weeks postpartum
|
Incidence of urinary tract infections (UTI) requiring antibiotics in the first 4 weeks postpartum |
first 4 weeks postpartum
|
|
Incidence of bladder injury in surgery
기간: During surgery
|
Incidence of bladder injury in surgery will be collected via an electronic post-operative questionnaire filled out by the operating surgeon. |
During surgery
|
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Operating time
기간: During surgery
|
Operating time will be collected via an electronic post-operative questionnaire filled out by the operating surgeon. |
During surgery
|
|
Patient satisfaction as measured by the Maternal Satisfaction for Cesarean Section questionnaire (MSCS)
기간: At discharge, assessed up to 3 days postpartum
|
Patients will be asked to complete the Maternal Satisfaction for Cesarean Section questionnaire at discharge. The minimum and maximum values are 7 and 154 and higher scores mean a better outcome. |
At discharge, assessed up to 3 days postpartum
|
|
Time to discharge
기간: At discharge, assessed up to 3 days postpartum
|
Time to discharge; date and time of discharge will be collected during chart review |
At discharge, assessed up to 3 days postpartum
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Stephen L. Wood, MD, MSc, University of Calgary
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- REB24-0044
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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