Focused-PPC: An Integrated Postpartum Care, Education, and Support Model for Women in Ghana (Focused-PPC)
2022年3月4日 更新者：University of Notre Dame
The purpose of this project is to test and evaluate an innovative postpartum care, education, and support model that integrates recommended clinical care, education, and support for women in a group setting.
Aim 1. Develop an innovative integrated group postpartum care, education, and support model entitled Focused-PPC for postpartum women up to one year after delivery.
Aim 2. Implement and evaluate this integrated postpartum care model entitled Focused-PPC in a parallel randomized controlled trial with 192 postpartum women at 4 health centers in Tamale, Ghana.
調査の概要
詳細な説明
Although the postpartum period poses substantial risks and can result in significant maternal morbidity and mortality, it receives much less attention than pregnancy and childbirth.
Appropriate postpartum care enables healthcare providers identify and treat postpartum complications promptly, offer help with a wide range of health and social needs and encourage mothers to adopt evidenced-based postpartum practices at home, since maternal self-care usually takes place at home.
In many settings in Sub-Saharan Africa, quality postpartum care, education, and support for the mother are often the missing components of postnatal care delivery, which focuses on care of the baby.
The lack of standard postpartum care for the mother contributes to maternal deaths.
There is an urgent need for an integrated postpartum care delivery model that is comprehensive and meets clinical care, education, and support needs of mothers.
Thus, the purpose of this project is to test and evaluate an innovative postpartum care, education, and support model known as Focused-PPC, in Tamale, Ghana.
The proposed project will be the first of its kind to design an integrated and comprehensive group postpartum care delivery model, focused on clinical care of the mother and baby, as well as education and peer support in Ghana.
Our model supports the clinical assessments and timeframes recommended by the World Health Organization and adopted by Ghana Health Service.
Together with my partner organization, Savana Signatures, we will develop and test Focused-PPC.
Focused-PPC will be implemented in groups in health centers in Tamale, Ghana.
Each group will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year postpartum following the Ghana health service postnatal care schedule.
Led by trained midwives in the health centers, each group session will consist of postpartum clinical assessments for mother (in addition to baby), education, and support.
Focused-PPC has the potential to change the postpartum care delivery model in Ghana and other countries in sub-Saharan Africa and beyond.
Results from this implementation will be used to further refine and scale up the Focused-PPC model of postpartum care.
研究の種類
介入
入学 (予想される)
192
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Principal Investigator
- 電話番号：+1 574 631 3224
- メール：yadams@nd.edu
研究場所
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Tamale、ガーナ
- 募集
- Bagabaga Health Center
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コンタクト：
- Project Manager
- 電話番号：+233243601588
- メール：emefa@savsign.org
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Tamale、ガーナ
- 募集
- Choggu Health Center
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コンタクト：
- Project Manager
- 電話番号：+233243601588
- メール：emefa@savsign.org
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Tamale、ガーナ
- 募集
- Kalpohin Health Center
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コンタクト：
- Project Manager
- 電話番号：+233243601588
- メール：emefa@savsign.org
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Tamale、ガーナ
- 募集
- Kanvilli Health Center
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コンタクト：
- Project Manager
- 電話番号：+233243601588
- メール：emefa@savsign.org
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
女性
説明
Inclusion Criteria at Recruitment:
- 18 years and older, third trimester of pregnancy, able to understand English or "Dagbani" (the local language)
Inclusion Criteria at Enrollment:
- 18 years and older, had a live birth, able to understand English or "Dagbani" (the local language)
Exclusion Criteria:
- Had a stillbirth
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：ランダム化
- 介入モデル：並列代入
- 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：Focused-PPC Group
Focused-PPC will be implemented in 12 groups (3 groups per health center), with each group having 8 postpartum women.
Each group will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year postpartum following the Ghana Health Service (GHS) postnatal care schedule.
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Individual clinical assessments and counseling for each group member will last about 15 minutes.
Then, there will be 1 hour of group time dedicated to education and support.
Each group session will be led by two trained and registered midwives who will provide both clinical care, education, and support as needed.
In addition, each group session will be supported by a project assistant.
Focused-PPC will be implemented in addition to newborn care.
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アクティブコンパレータ：Standard PNC Group
The control group will contain parallel number of participants as the intervention group in each health center
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Women in the control group will receive standard postnatal care (PNC) currently practiced in the health centers.
This involves attending PNC visits at the health center within 14 days after birth, at 6 weeks, and monthly thereafter up to one year.
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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 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Post-Birth Warning Signs Identified Per Participant
時間枠：1 year
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Knowledge of post-birth warning signs will be assessed using a question that asks participants to identify (check all that apply) warning signs of complications. Response options will include nine post-birth warning signs. Each item will be recorded as dichotomous, with a value of 1 assigned if the woman identified the warning sign and 0 if she did not. The total knowledge score will be the sum of these dichotomous items. The mean knowledge score will be calculated as the total knowledge score divided by 9 and reflect the percentage of warning signs known. We will model and test the between treatment and control group's knowledge of post-birth warning signs at each timepoint and between timepoints will be assessed using a repeated measure multivariate analysis of variance (MANOVA) with a time and treatment interaction will be run as the primary analysis controlling for baseline demographic variables. |
1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postpartum Health Behaviors Practiced
時間枠：1 year
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Postpartum Health Behaviors will be assessed using a questionnaire.
The questionnaire will identify which PNC visits the participant attended, how participants feed their baby, how often the participant adheres to the 4-star diet, feelings on getting pregnant within 6 months of giving birth, plans on getting pregnant within 6 months of giving birth, and intentions on getting pregnant within 6 months of giving birth.
The researchers expect health behaviors to be different between the Focused-PPC and control groups.
All health behavior questions are all categorical and will be aggregated using latent class analysis.
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1 year
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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postpartum health status
時間枠：1 year
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overall health and mental health
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1 year
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Overall Satisfaction of Focused-PPC Sessions
時間枠：1 year
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Using a questionnaire, we will record how satisfied participants were with the education received during the Focused-PPC sessions, the clinical care received during the Focused-PPC sessions, whether length of sessions was satisfactory or disliked, whether length of sessions was satisfactory or disliked, whether information provided was satisfactory or disliked, whether peer support was satisfactory or disliked, and whether the group format was liked by participants.
These measures are all categorical and will be aggregated using factor analysis.
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1 year
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Yenupini J Adams, PhD, BSN、University of Notre Dame
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2022年2月26日
一次修了 (予想される)
2023年1月1日
研究の完了 (予想される)
2023年6月1日
試験登録日
最初に提出
2022年2月10日
QC基準を満たした最初の提出物
2022年3月4日
最初の投稿 (実際)
2022年3月15日
学習記録の更新
投稿された最後の更新 (実際)
2022年3月15日
QC基準を満たした最後の更新が送信されました
2022年3月4日
最終確認日
2022年3月1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。
産後ケアの臨床試験
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Washington University School of MedicineColumbia University; Indiana University; Rakai Health Sciences Program; Reach the Youth Uganda完了コントロールアーム_Bolstered Care | 治療アーム_HIVRR+S+FL | 治療ARM_HIVRR+S+FL+Mウガンダ
Focused-PPC Careの臨床試験
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The University of Texas Medical Branch, GalvestonThe University of Texas Health Science Center, Houston完了
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Michael Lichtenberg, MD募集
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C. R. Bard完了
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Association Nationale pour les Traitements A Domicile...わからない
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Centre Hospitalier Universitaire de Saint EtienneAssociation Lyonnaise de Logistique Posthospitalière終了しました
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Massachusetts General HospitalNational Cancer Institute (NCI); American Cancer Society, Inc.完了