- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01945931
Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia
Evaluation of a Smartphone Application to Reduce Adverse Pregnancy Outcomes in Ethiopia: A Cluster-randomised Controlled Trial
연구 개요
상세 설명
Abstract Hypothesis A safe delivery smartphone application distributed to health workers in Ethiopia will decrease perinatal mortality and the incidence of postpartum haemorrhage
A safe delivery smartphone application distributed to health workers in Ethiopia will increase health workers knowledge and skills in intra-partum management of active management of third stage labour 2) treatment of post-partum haemorrhage 3) manual removal of placenta and 4) neonatal resuscitation
Intervention A safe delivery smartphone application with animated videos to improve clinical management during delivery will be introduced in the intervention clusters
Design Cluster randomized controlled trial with health facilities as the unit of randomization
Area Nole Kaba, Haru, Homa, Genji and Gimbie districts in Ethiopia
Population Pregnant women and their newborns delivered in a randomized health facility. For secondary outcomes health workers at randomized health facilities.
Sample size 77 health facilities with minimum 2 health workers per facility and 30 deliveries per health worker
Duration Pregnant women will be enrolled at delivery and followed to 7 days postpartum
Outcomes Primary outcomes are perinatal mortality and postpartum haemorrhage. Secondary outcomes are health workers knowledge and skills
Study time Data collection expected from September 2013 to September 2014
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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København V, 덴마크, 1658
- University of Copenhagen
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
• Women in active labor
Exclusion Criteria:
• None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Safe Delivery Smartphone Application
The safe delivery smartphone application is designed to train midwives and other birth attendants in developing countries in management of normal and complicated deliveries.
The safe delivery smartphone application will be introduced to health workers in the intervention clusters.
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The safe delivery smartphone application is designed to train midwives and other birth attendants in developing countries in management of normal and complicated deliveries.
The application is furthermore intended as a reference tool that could be used during clinical work for example for preparation before attending a birth, in a situation when a complication occurs, or for debriefing and self-evaluation after a complication.
The application features four animated videos with clinical instructions of 3-8 minutes duration and written lists of essential obstetric drugs (indications, contraindications, dosage and administration and side effects) and essential equipment for a safe delivery.
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간섭 없음: Control
Health workers in the control clusters will not have access to the Safe Delivery App
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Perinatal mortality (stillbirth and early neonatal death)
기간: Participants will be followed from delivery until 7 days postpartum
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Participants will be followed from delivery until 7 days postpartum
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Postpartum haemorrhage
기간: Participants will be followed from delivery until two hours postpartum
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Participants will be followed from delivery until two hours postpartum
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2차 결과 측정
결과 측정 |
기간 |
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Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta
기간: 0, 6 and 12 months
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0, 6 and 12 months
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Health workers clinical performance in management of neonatal resuscitation
기간: 0, 6 and 12 months
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0, 6 and 12 months
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Health workers knowledge of management of active management of third stage of labour, manual removal of placenta and postpartum haemorrhage
기간: 0, 6 and 12 months
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0, 6 and 12 months
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Health workers knowledge of management of neonatal resuscitation
기간: 0, 6 and 12 months
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0, 6 and 12 months
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기타 결과 측정
결과 측정 |
기간 |
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Mortality stratified according to gestational age and birth weight
기간: Participants will be followed from delivery until 7 days postpartum
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Participants will be followed from delivery until 7 days postpartum
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Use of the Safe Delivery application (when, how much and by whom)
기간: Participants will be followed during the 12 months trial period
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Participants will be followed during the 12 months trial period
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Process indicators of services provided
기간: Participants will be followed from delivery until 7 days postpartum
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Participants will be followed from delivery until 7 days postpartum
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공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
모성 사망에 대한 임상 시험
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University of Haifa완전한산후 기간 | 산모 정신 건강 | Parenting / Maternal Behavior | 초산 (첫 아이를 임신한 산모) | 산후 우울 증상이스라엘