- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07686419
Labor Care Guide Application (LCG)
Labor Care Guide Application in Ain Shams University Maternity Hospital: A Randomized Controlled Trial
연구 개요
상세 설명
The Labor Care Guide (LCG) is a tool developed by the World Health Organization (WHO) to support evidence-based, woman-centered intrapartum care and improve labor monitoring. It was introduced as an alternative to the traditional partograph, aiming to facilitate timely clinical decision-making and enhance the quality of maternity care.
This randomized controlled trial was conducted at Ain Shams University Maternity Hospital to evaluate the effect of the WHO Labor Care Guide on maternal and neonatal outcomes among women undergoing vaginal delivery. Eligible pregnant women were randomly assigned to one of two groups: a study group monitored using the WHO Labor Care Guide and a control group monitored using the modified WHO partograph.
Participants underwent routine obstetric assessment and monitoring throughout labor according to the allocated monitoring tool. Maternal outcomes assessed included labor progression, mode of delivery, and intrapartum and postpartum complications. Neonatal outcomes included neonatal well-being, need for neonatal intensive care admission, and neonatal complications. Healthcare provider satisfaction with the labor monitoring tool was also evaluated.
The study aimed to compare the effectiveness of the WHO Labor Care Guide with the modified WHO partograph in supporting labor management and improving maternal and neonatal care.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Cairo, 이집트
- Ain Shams University Maternity Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Pregnant woman who will undergo vaginal delivery at Ain Shams University Maternity Hospital with gestational age above or equal 37 weeks
- Vertex presentation .
- Women with estimated fetal weight 2.5 till 4 kg
Exclusion Criteria::
- Placenta previa
- Placenta previa accreta
- Macrosomic baby above 4 kg in diabetic women and above 4.5 kg in non diabetic women
- Placenta abruption complicated by non reassuring CTG or life threatening bleeding
- Cord prolapse
- Vasa previa
- Primary active genital herpes simplex
- Patient with anemia which may lead to atonic uterus and prolonged labor.
- Women with previously scarred uterus due to risk of ruptured uterus and postpartum hemorrhage
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Labor care guide
Intervensional study
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labor monitoring tool
|
|
간섭 없음: partogrph
no intervension
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Healthcare Provider Satisfaction as Measured by the Provider Satisfaction Questionnaire (PSQ)
기간: assessed at 6 months
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Measured using a 5-point Likert scale.
Range: 1-5.
Higher scores indicate greater satisfaction.
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assessed at 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Mode of delivery
기간: At delivery
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The percentage of participants undergoing different modes of delivery (e.g., normal vaginal delivery, operative vaginal delivery, or cesarean section)
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At delivery
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Duration of active labor
기간: At delivery
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The total duration of the active phase of labor, measured in hours.
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At delivery
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Incidence of maternal complications
기간: assessed at 6 weeks postpartum
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The percentage of mothers who experience any postpartum or intrapartum complications (e.g., postpartum hemorrhage, infection).
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assessed at 6 weeks postpartum
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Incidence of neonatal complications
기간: At delivery
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The percentage of newborns who experience neonatal complications (e.g., respiratory distress, hypoglycemia).
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At delivery
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Duration of hospital stay
기간: from birth until hospital discharge average 2 to 3 days
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The total number of days the mother and/or neonate remained hospitalized from admission to discharge.
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from birth until hospital discharge average 2 to 3 days
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Neonatal Outcomes via Apgar Score and NICU Admission
기간: from birth until hospital discharge average 2 to 3 days
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Neonatal well-being will be assessed using the Apgar score at 5 minutes (ranging from 0 to 10, where higher scores indicate better neonatal health) and the rate of admission to the Neonatal Intensive Care Unit (NICU).
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from birth until hospital discharge average 2 to 3 days
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공동 작업자 및 조사자
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
기타 연구 ID 번호
- MS459
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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