- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01115361
Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services (PPFP-IZ)
Improving Access to and Uptake of Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Study Goal:
To determine the effectiveness of an intervention, which is designed to increase contraceptive prevalence among postpartum women attending vaccination services who desire to either space or limit their pregnancies, thus reducing unmet contraceptive need in this population.
The Intervention:
A. Brief, concise messages conveyed to women during group education sessions regarding pregnancy risk, benefits of FP, and family planning options during the postpartum period.
B.IEC materials such as posters and brochures that deliver messages about the benefits of spacing pregnancies by at least 2 years, LAM, return to fecundity and pregnancy risk during the postpartum period and contraceptive options for postpartum women.
C.Use of a screening tool (Appendix A) to assess pregnancy risk for postpartum women coupled with a brief counseling message depending upon risk classification which includes referral to FP services for those currently or soon-to-be at-risk of pregnancy.
D.Convenient offer of FP services to women attending vaccination services for their infants either concurrently with vaccination services, or at the same facility and on the same day, but at a different time from vaccination services.
Study Design:
Experimental, two-group (intervention/control) pretest (pre-intervention) /posttest (post-intervention) design 12 month intervention period. A mid-course collection of process data will also be conducted at 6 months to assess the degree to which the intervention is being implemented as intended and to provide an opportunity for corrective action if needed.
Participants: Women attending vaccination services for their infants, and vaccination and FP providers
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Kigali, Ruanda
- Rwanda health care facilities
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Clients:
- adult women, aged 21 years and older, or married women ages 18 to 20 who have achieved legal majority status by emancipation due to marriage,
- bring their infants between the ages 6-12 months to immunization services at study sites
Providers:
- all health care providers who currently provide immunization services to infants and/or family planning services within the selected facilities.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: PPFP in child immunization
Women attending immunization services for their infant will receive educational brochures, group education and individual counseling on the benefits of the health timing and spacing of births,, pregnancy risk and return to fertility during the extended postpartum period (12 months), and referral to family planning services for those who are interested.
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A.Group education sessions regarding pregnancy risk, benefits of FP, and family planning options during the postpartum period. B. IEC materials that deliver messages about the benefits of spacing pregnancies by at least 2 years, LAM, return to fecundity and pregnancy risk during the postpartum period and contraceptive options for postpartum women. C. Use of a screening tool to assess pregnancy risk for postpartum women coupled with a brief counseling message and referral to FP services. D.Convenient offer of FP services to women attending vaccination services for their infants. |
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Sem intervenção: Control - Standard of care
The control arm will receive standard of care infant immunization services.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Use of a modern contraceptive method among postpartum women
Prazo: 1 year
|
The outcome variable is a dichotomous variable - use of modern FP method: yes/no
|
1 year
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Lisa S Dulli, PhD, MHS, FHI 360
- Diretor de estudo: Steve Sortijas, MPH, FHI 360
- Investigador principal: Fidèle Ngabo, MD, MPH, Ministry of Health, Rwanda
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 (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 890028
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