NCT05385380

Brief Summary

Despite the efforts from the government, maternal healthcare services utilization is far below the recommended level in Ethiopia with a high urban-rural disparity. Currently, two-thirds of pregnant women do not receive the recommended number of antenatal care, more than 50% of births are not attended by skilled birth attendants, and two-thirds of postpartum women do not receive postnatal checks, according to the 2019 EDHS report. There is also evidence that the rate of continuity of maternity care completion is low, implying that pregnant women are not getting the most out of the existing healthcare services. In Ethiopia, the rural communities are scattered over a wide geographic area some with difficult mountains and valleys. Hence, geographic barriers and limited information sources are likely to influence women's access to skilled birth attendance. As part of improving access and overcoming physical or geographical inaccessibility in rural areas, maternity waiting homes; residential lodgings built near healthcare facilities where expectant women near or at term would stay till the onset of labor is one of the measures taken by the Ethiopian government. The majority of the rural populations commonly have a lower perception of health services in general, and many traditional practices support behaviors that are inconsistent with effective health interventions. Thus, there is a challenge concerning behavior (social norms, beliefs, and culture) from the demand side related to utilizing maternity services on top of non/partial functionality of existing waiting homes. Therefore, this research project aimed at promoting access to and utilization of maternal healthcare services utilization in southern Ethiopia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
727

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 14, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2020

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

May 10, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 23, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

May 10, 2022

Last Update Submit

May 26, 2022

Conditions

Keywords

Antenatal careBirths attended by skilled health providersBirth Preparedness PlanPostnatal care

Outcome Measures

Primary Outcomes (2)

  • the location of the delivery (home vs. health facility)

    institutional birth was used to indicate skilled birth attendance as trained health workers do not conduct deliveries outside of health facilities in these areas.

    through study completion, an average of 9 months

  • health facility visits after childbirth (postnatal care use)

    Having visited postnatal clinic after delivery

    through study completion, an average of 9 months

Secondary Outcomes (2)

  • knowledge of obstetric danger signs

    through study completion, an average of 9 months

  • birth preparedness practice

    through study completion, an average of 9 months

Study Arms (2)

Safe motherhood Promotion(Educational, Counselling & Training) and maternity waiting homes upgrading

EXPERIMENTAL

1. Improving the quality of maternal health services in health centers (training for midwives in basic emergency obstetric care and upgrading maternity waiting homes to the level to provide basic accommodation to address access-related barriers 2. Training community health workers with the aim of improving their knowledge about safe motherhood and about how to prepare a birth plan, including stays in maternity waiting homes 3. Training pregnant women

Behavioral: Safe motherhood Promotion

Comparison

NO INTERVENTION

The current standard service package

Interventions

Interventions included the training of community members, who subsequently led participatory educational sessions on safe motherhood topics with pregnant females. The project staff identified 2 community health workers and 15 female volunteers from each kebele cluster and trained them as research implementers. The implementers received 2 days of training led by the project team. The project staff and research implementers conducted safe-motherhood training comprising 2 h of information presentations and discussions with pregnant females in the intervention clusters. In addition to the pregnant-female intervention strategy, we also conducted a four-day training programme on clinical skills for local maternal and child healthcare providers in the study area. MWH intervention was also implemented in the intervention group, including upgrades to existing MWH services per national guidelines to standardize services and create a homelike environment for pregnant females.

Also known as: improving maternity waiting homes
Safe motherhood Promotion(Educational, Counselling & Training) and maternity waiting homes upgrading

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe intervention is planned to be delivered to pregnant female.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MEKDES KONDALE Gurara

Arba Minch, Southern Nations Nationalities Regional State, 21, Ethiopia

Location

Related Publications (1)

  • Gurara MK, Draulans V, Jacquemyn Y, Van Geertruyden JP. Evaluation of a community-based intervention package to improve knowledge of obstetric danger signs, birth preparedness, and institutional delivery care utilization in Arba Minch Zuria District, Ethiopia: a cluster-randomized trial. Reprod Health. 2023 Nov 18;20(1):169. doi: 10.1186/s12978-023-01713-w.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: A total of 727 pregnant women were recruited and followed up to six months after delivery in this quasi-experimental, two-arm, controlled study. In the intervention group, eligible pregnant women received training to promote safe motherhood, supported by the story "Why Did Mr. X Die, Retold?" and a booklet on working with individuals, families and communities to promote maternal and neonatal health. Pregnant women received counselling (12 sessions/4 sessions per cluster) and biweekly check-ins were performed by community health workers. Pregnant women are encouraged to stay in maternity waiting homes, which have been upgraded to accommodate pregnant women while they wait for their baby to arrive. The control group received standard maternal health information and services as part of the standard health care system.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 10, 2022

First Posted

May 23, 2022

Study Start

September 14, 2019

Primary Completion

October 17, 2020

Study Completion

November 20, 2020

Last Updated

June 1, 2022

Record last verified: 2022-05

Locations