- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01653626
A Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
A Matched Pair Cluster-randomized Implementation Study to Measure the Effectiveness of an Intervention Package Aiming to Decrease Perinatal Mortality and Increase Institution-based Obstetric Care Among Indigenous Populations in Guatemala
A matched pair cluster-randomized trial of this intervention package will be conducted in four rural and indigenous districts (Huehuetenango, Quiche, Alta Verapaz and San Marcos) of the Republic of Guatemala, using the health clinic as the unit of randomization. No external intervention is planned for control facilities, although enhanced monitoring, surveillance and data collection will occur throughout the study in all facilities in the four districts.
The package includes 3 interventions: 1) To train health care professionals in emergency obstetric and perinatal care using an innovative high-fidelity, low-tech, in situ, multidisciplinary simulation training curriculum (PRONTO); 2) To design and implement a social marketing strategy that promotes institution-based delivery; and 3) To integrate the role of obstetric nurse and professional midwife in intervention communities to act as liaisons between traditional birth attendants (TBA) and public health units. A fourth, cross-cutting component involves ongoing analysis, monitoring, surveillance and evaluation to strengthen information systems and monitor perinatal outcomes throughout the two years of the study.
연구 개요
상세 설명
Overall goal
To evaluate the impact of a package of three interventions aiming to increase institution-based delivery and improve emergency obstetric and neonatal care on perinatal mortality, in the four districts with the highest maternal mortality ratios in Guatemala.
Specific objectives
- Measure the impact of this intervention package on perinatal mortality rates.
- Measure the impact of this intervention package on the proportion of institution-based delivery among study facilities.
- Evaluate the processes and success of implementing this combined package of interventions by analyzing process indicators related to the intervention element designed to improve emergency obstetric and neonatal care (PRONTO: emergency obstetric and perinatal training program).
Primary outcome of interest:
- Increase in the proportion of institutional deliveries in intervention vs. control clusters.
- Decrease perinatal death rate in intervention vrs control clinics
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Departamento de San Marcos, 과테말라
- 모병
- Health Centers for vaginal deliveries (CAP)
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연락하다:
- Edgar E. Kestler, MD
- 전화번호: (502) 22301494
- 이메일: ciesar@ciesar.org.gt
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부수사관:
- Dilys Walker, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- rural women
- indigenous
- poor
- Facilities at rural area
- Clinic attending vaginal deliveries
Exclusion Criteria:
- Facilities considered too close geographically to risk contamination of intervention to control facilities
- Clinics visits by pregnant women who present to intervention or control clinics for reasons other that an obstetric event
- Clinic or hospital visits by women who present to intervention or control clinics in the post partum period
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: package
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Emergency Obstetric Care training, social marketing approach and link TBS with public sector services
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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increase the proportion of institutional deliveries in intervention vs. control clusters
기간: Up to 15 months
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Up to 15 months
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2차 결과 측정
결과 측정 |
기간 |
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Decrease perinatal death rate in intervention vs. control clinics
기간: Up to 15 months
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Up to 15 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Edgar E Kestler, MD, CIESAR
- 수석 연구원: Edgar E. Kestler, MD, CIESAR
간행물 및 유용한 링크
일반 간행물
- Walker DM, Holme F, Zelek ST, Olvera-Garcia M, Montoya-Rodriguez A, Fritz J, Fahey J, Lamadrid-Figueroa H, Cohen S, Kestler E. A process evaluation of PRONTO simulation training for obstetric and neonatal emergency response teams in Guatemala. BMC Med Educ. 2015 Jul 24;15:117. doi: 10.1186/s12909-015-0401-7.
- Kestler E, Walker D, Bonvecchio A, de Tejada SS, Donner A. A matched pair cluster randomized implementation trail to measure the effectiveness of an intervention package aiming to decrease perinatal mortality and increase institution-based obstetric care among indigenous women in Guatemala: study protocol. BMC Pregnancy Childbirth. 2013 Mar 21;13:73. doi: 10.1186/1471-2393-13-73.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
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. .
package of 3 interventions에 대한 임상 시험
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Oregon Center for Applied Science, Inc.Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)완전한
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Yardley Dermatology AssociatesTopix Pharmaceuticals, Inc종료됨
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University of Miami모병