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
調査の概要
詳細な説明
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
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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København V、デンマーク、1658
- University of Copenhagen
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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:
• Women in active labor
Exclusion Criteria:
• None
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：処理
- 割り当て：ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的：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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介入なし：Control
Health workers in the control clusters will not have access to the Safe Delivery App
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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 |
|---|---|
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Perinatal mortality (stillbirth and early neonatal death)
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
時間枠 |
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Health workers clinical performance in active management of third stage of labour, postpartum haemorrhage and manual removal of placenta
時間枠：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
時間枠：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
時間枠：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
時間枠：0, 6 and 12 months
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0, 6 and 12 months
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その他の成果指標
結果測定 |
時間枠 |
|---|---|
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Mortality stratified according to gestational age and birth weight
時間枠：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)
時間枠：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
時間枠：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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協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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
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