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

3 november 2020 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

3784

Fase

  • Niet toepasbaar

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

15 jaar en ouder (Kind, Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Geen tussenkomst: Controle
Experimenteel: MWA+IEC intervention
Ander: 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.
Ander: 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.
Experimenteel: IEC intervention
Ander: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Facility-based birth coverage
Tijdsspanne: 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)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Antenatal care coverage
Tijdsspanne: 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
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Ottawa

Medewerkers

Jimma University
Ethiopian Ministry of Health, Jimma Zone

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 oktober 2016

Primaire voltooiing (Werkelijk)

1 mei 2019

Studie voltooiing (Werkelijk)

1 oktober 2020

Studieregistratiedata

Eerst ingediend

27 september 2017

Eerst ingediend dat voldeed aan de QC-criteria

27 september 2017

Eerst geplaatst (Werkelijk)

3 oktober 2017

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 november 2020

Laatste update ingediend die voldeed aan QC-criteria

3 november 2020

Laatst geverifieerd

1 november 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 108028-002

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

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