Faith Leaders Advocating for Maternal Empowerment (FLAME)

Prenatal Care Clinical Trial

Official title:

Faith Leaders Advocating for Maternal Empowerment (FLAME)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04039932
• Other study ID #: STUDY00001662
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: October 2021
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In 2015, the average Ethiopian woman had a 1 in 64 lifetime risk of death due to complications of childbirth and 87,414 newborns died before their 28th day of life. Demand for MNCH services, however, remains low in Ethiopia's rural communities most at risk with only 16% of women delivering in a health facility.

The investigator's project responds to the challenge of creating demand for existing MNCH services in rural Ethiopia, which fell short of reaching Millennium Development Goal targets for reducing preventable maternal and neonatal deaths. This study addresses two strategic drivers to prevent maternal mortality identified by USAID including improving individual, household, and community behaviors and norms and increasing equity of access and use of services by the most vulnerable.

The primary objective of the study is to determine the impact of a behavior change intervention that partners Ethiopian Orthodox priests with members of the Health Development Army (HDA) and trains them to conduct maternal health outreach to increase births attended by skilled health personnel among women who attend ≥1 ANC visits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Pregnant women

• Willing to receive intervention counseling

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Maternal Health Services
• Perinatal Care
• Prenatal Care

Intervention

Behavioral:
• FLAME
The FLAME intervention trains pairs of faith leaders and community health workers and deploys them to conduct behavior change outreach in their communities.

Locations

Country	Name	City	State
Ethiopia	University of Gondar	Gondar	Amhara

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	University of Gondar

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facility delivery	The proportion of births attended by skilled health personnel among the women who attended =1 ANC visits	Through study completion, an average of 18 months
Secondary	Any ANC	Number of women who attended =1 ANC visits	Through study completion, an average of 18 months
Secondary	Complete ANC	Number of women who attended ANC 4	Through study completion, an average of 18 months