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An Implementation Study of Interventions to Promote Safe Motherhood in Jimma Zone Ethiopia

3 de novembro de 2020 atualizado por: Manisha Kulkarni, PhD, University of Ottawa
Ethiopia has one of the highest rates of maternal mortality among all countries in Africa and indeed worldwide, with a maternal mortality ratio of 676 per 100,000 live births in 2011 (UNFPA, 2012). The majority of maternal deaths are preventable through early detection and management of complications, and access to adequate obstetric care (Say et al, 2014). However, in 2011 only 34% of women received antenatal care, 10% of births were delivered at a health facility and 7% of women received postnatal care during the first two days after delivery (Ethiopian DHS, 2011). Large distances and poor access to transport are two major obstacles that women face when trying to access services. In order to facilitate timely access to obstetric care, the Ethiopian Government introduced Maternity Waiting Areas (MWAs) at health centres to enable women to stay close to health facilities as they await delivery. Utilization of MWAs has generally been low due to the poor state of the homes and lack of adequate community support. This study aims to evaluate the effectiveness of two interventions to promote safe motherhood in increasing coverage of maternal health care services: (i) upgraded MWAs (ii) community and religious leader sensitization using information, education and communication (IEC) materials. The IEC materials are expected to increase leader awareness and support of antenatal care, facility deliveries, postnatal care and MWA use. Together with increased use of functional MWAs, improved support from leaders is expected to increase the proportion of facility-based births in interventions area. The interventions are also expected to positively impact antenatal care and postnatal care use in the study districts.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

A three-arm cluster trial design will be used to measure the impact of the intervention packages in three districts (Gomma, Seka Chekorsa, Kersa) in Jimma Zone, Ethiopia. Twenty-four clusters with 160 individuals each are required to detect a 17% change in the primary outcome (proportion of facility-based births) with 80% power,assuming a cluster autocorrelation of 0.8 and an intra-cluster correlation coefficient of 0.1. Primary health care units (PHCU) which consist of a health centre and several community-based health posts will serve as trial clusters. All PHCUs with maternity waiting areas (MWAs) constructed will be eligible for selection. Eligible women will be randomly selected from PHCU catchment areas stratified by MWA functionality and health centre basic emergency obstetric care (BEmOC) capacity. This is to ensure balanced distribution of poorly functioning MWAs and facilities with diminished BEmOC capacity between trial arms.

Cross-sectional household surveys will be conducted with eligible women to collect information on socio-demographics, knowledge, attitudes and practices regarding maternal health services, reproductive history and maternal health service utilization. Surveys will be administered by trained interviewers on tablet computers programmed using Open Data Kit at baseline prior to intervention roll out and at endline. Multilevel regression models will be used to quantify the effect of the intervention packages on outcomes of interest. Random effect terms for PHCUs will be included to account for the clustered nature of the data.

Tipo de estudo

Intervencional

Inscrição (Real)

3784

Estágio

  • Não aplicável

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

15 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Fêmea

Descrição

Inclusion Criteria:

  • Women who were pregnant up to one year prior to the baseline survey and had a live birth, stillbirth or abortion (spontaneous or induced) and are residents in the study districts during the survey period are eligible to take part in the study.

Exclusion Criteria:

  • Women who are not able to provide informed consent due to severe illness or mental health conditions.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: Ao controle
Experimental: MWA+IEC intervention
Outro: MWA intervention
The MWA intervention will involve upgrading existing maternity waiting areas to ensure that essential supplies and services are available to create a comfortable environment for women to temporarily reside in and have easy access to skilled obstetric services.
Outro: IEC intervention

Community and religious leaders will each attend one-day workshops designed using participatory, adult learning methods to help participants better understand the importance of maternal health care services, identify barriers to accessing care and to strategize how to promote utilization of services. Half-day workshops will conducted in subsequent years to build on shared experiences.

Health extension workers will attend 3-day workshops to identify enablers and barriers to implementation of the safe motherhood components of the health extension program and strategize on how to engage community and religious leaders to support access to maternal health care services in their communities.

Half-day workshops will conducted in subsequent years for each of the participant groups to build on shared experiences.
Experimental: IEC intervention
Outro: IEC intervention

Community and religious leaders will each attend one-day workshops designed using participatory, adult learning methods to help participants better understand the importance of maternal health care services, identify barriers to accessing care and to strategize how to promote utilization of services. Half-day workshops will conducted in subsequent years to build on shared experiences.

Health extension workers will attend 3-day workshops to identify enablers and barriers to implementation of the safe motherhood components of the health extension program and strategize on how to engage community and religious leaders to support access to maternal health care services in their communities.

Half-day workshops will conducted in subsequent years for each of the participant groups to build on shared experiences.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Facility-based birth coverage
Prazo: Information on the primary outcome will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
Proportion of women who report giving birth to their last child at a health facility (health centre or hospital) which has skilled birth attendants present (doctor, midwife, clinical nurse).
Information on the primary outcome will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Antenatal care coverage
Prazo: Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
Proportion of women who report making at least one antenatal care visit to a health facility during their last pregnancy.
Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
Postnatal care coverage
Prazo: Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)
Proportion of women who report receiving a checkup from a healthcare worker at least once during the 42 days after delivery of their last child.
Information on secondary outcomes will be collected through surveys at baseline (prior to intervention roll out) and endline (approximately one and a half years after intervention roll out has commenced)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

University of Ottawa

Colaboradores

Jimma University
Ethiopian Ministry of Health, Jimma Zone

Investigadores

  • Investigador principal: Manisha Kulkarni, PhD, University of Ottawa
  • Investigador principal: Lakew Abebe, MPH, Jimma University

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de outubro de 2016

Conclusão Primária (Real)

1 de maio de 2019

Conclusão do estudo (Real)

1 de outubro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

27 de setembro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de setembro de 2017

Primeira postagem (Real)

3 de outubro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de novembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de novembro de 2020

Última verificação

1 de novembro de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 108028-002

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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