- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02674542
Family Planning Intentions and Practices Among Women With Poor Obstetric Outcome
Family Planning Intentions and Practices Among Women Who Have Experienced a Poor Obstetric Outcome: a Qualitative Study
Women who have experienced a stillbirth or neonatal death are at higher risk of repeated poor neonatal outcomes if they have short interpregnancy intervals. Understanding the attitudes surrounding future fertility and contraception in this population is critical to propose socially and culturally acceptable interventions to address an unmet need for family planning.
Participants: Women who have experienced a stillbirth or early neonatal death will be recruited from the postnatal ward of Bwaila Maternity Hospital in Lilongwe, Malawi.
Procedures (methods): This will be a qualitative study using 20 in-depth interviews and four focus group discussions of up to 10 women each.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The investigators propose a qualitative study of up to 60 women who have experienced a stillbirth or early neonatal death. This will be a qualitative study using 20 in-depth interviews and four focus group discussions of up to 10 women each. In-depth interviews will be conducted in Chichewa in a private room either within the participants' homes or in another private location determined by the participant.
Each interview will take approximately 60-90 minutes to complete. The focus group discussions will be conducted in a private room in a health facility with 6-10 participants. These will take approximately 90-120 minutes to complete. Interviews and the focus group discussion will be audio-recorded, transcribed, and translated to English. If a participant is found to be eligible, she will be invited to participate in the study. After the investigators complete the in-depth interviews, the investigators will analyze the data and modify our focus group discussion guide as needed to integrate new themes that may have emerged during the individual interviews. The investigators will recruit 6-10 women per focus group (24 to 40 total) from the same hospital that were used to recruit for the individual interviews.
The investigators will search for recurrent patterns and themes in data and for ideas that help to explain the presence of these patterns. The data collection and analysis process is designed to be iterative, such that the investigators will be reviewing data as it is collected and adjusting the data collection instrument to reflect new themes that emerge during the data collection process. All interviews will be audio-recorded, transcribed, translated, coded and computerized for analysis.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Lilongwe, Malauí
- UNC Project
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion criteria:
- Current admission to the postpartum ward at Bwaila Hospital,
- Women who have delivered a stillborn fetus over 28 weeks gestation or with a birthweight >1000 g or experienced a neonatal demise of a liveborn infant, weighing >1000 g in the first 7 days of life,
- Ability to speak Chichewa or English fluently, and
- Age 18-45 years old.
Exclusion criteria:
- Not willing to be audio-recorded
- Have not experienced stillbirth or early neonatal death
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Attitudes surrounding future fertility, birth spacing, family size, and contraception
Prazo: 1 year
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The investigators expect that the in-depth interviews and focus groups will allow them to better understand the family planning intentions and practices of women who have experienced a stillbirth or early neonatal demise.
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1 year
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Discovering feasible and acceptable interventions to promote birth spacing and family planning among women who have experienced a poor obstetric outcome
Prazo: 1 year
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The investigators will ask women who have experienced a stillbirth or neonatal demise questions about a variety of potential interventions to assist women with birth spacing and elicit their ideas on acceptable interventions.
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1 year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Dawn Kopp, MD, MPH, UNC-CH
Publicações e links úteis
Publicações Gerais
- Bula A, Kopp DM, Maman S, Chinula L, Tsidya M, Tang JH. Family planning knowledge, experiences and reproductive desires among women who had experienced a poor obstetric outcome in Lilongwe Malawi: a qualitative study. Contracept Reprod Med. 2018 Oct 17;3:22. doi: 10.1186/s40834-018-0075-8. eCollection 2018.
- Kopp DM, Bula A, Maman S, Chinula L, Tsidya M, Mwale M, Tang JH. Influences on birth spacing intentions and desired interventions among women who have experienced a poor obstetric outcome in Lilongwe Malawi: a qualitative study. BMC Pregnancy Childbirth. 2018 May 31;18(1):197. doi: 10.1186/s12884-018-1835-9.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UNCPM 21416
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
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