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.
調査の概要
詳細な説明
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
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Departamento de San Marcos、グアテマラ
- 募集
- Health Centers for vaginal deliveries (CAP)
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コンタクト：
- Edgar E. Kestler, MD
- 電話番号：(502) 22301494
- メール：ciesar@ciesar.org.gt
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副調査官：
- Dilys Walker, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：package
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Emergency Obstetric Care training, social marketing approach and link TBS with public sector services
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
|
increase the proportion of institutional deliveries in intervention vs. control clusters
時間枠：Up to 15 months
|
Up to 15 months
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Decrease perinatal death rate in intervention vs. control clinics
時間枠：Up to 15 months
|
Up to 15 months
|
協力者と研究者
捜査官
- 主任研究者：Edgar E Kestler, MD、CIESAR
- 主任研究者：Edgar E. Kestler, MD、CIESAR
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。