NCT05015023

Brief Summary

Maternity waiting homes (MWHs) were identified as a solution to improve pregnancy outcomes by bringing women living in geographically isolated areas closer to a healthcare facility. Literature shows that MWHs contribute significantly to the reduction of maternal death and stillbirth among users. Despite its importance in improving maternal \& neonatal health outcomes, the utilization of MWHs is very low in Ethiopia. It is important to investigate what strategies could be effective in improving MWH utilization. Therefore, in this study cluster-randomized controlled trials will be conducted to evaluate the effect of male partner involvement intervention on MWH utilization in Ethiopia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 3, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

February 8, 2023

Status Verified

February 1, 2023

Enrollment Period

6 months

First QC Date

August 3, 2021

Last Update Submit

February 3, 2023

Conditions

Keywords

maternity waiting home, male partner, Ethiopia

Outcome Measures

Primary Outcomes (1)

  • Utilization of MWH

    Utilization of MWH is the use of MWHs by pregnant women in their final weeks of pregnancy to bridge the geographic gap in obstetric care. It is the proportion of pregnant women who use MWHs in the final weeks of pregnancy among the eligible women who are study participants.

    up to six months

Secondary Outcomes (1)

  • Level of Maternal Knowledge and Attitude

    up to six months

Study Arms (2)

Intervention

EXPERIMENTAL

The behavioral intervention will be conducted on the experimental group for consecutive six months. The components of the intervention will be group health education, provision of IEC materials/Leaflets, and home visits.

Behavioral: Behavioral intervention

Control

NO INTERVENTION

The routine care will be continued in the control group.

Interventions

A cluster-randomized controlled trial will be conducted.

Intervention

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women at the beginning of second trimesters (14-16 weeks of gestation)
  • Pregnant women currently live with their male partners
  • Pregnant women permanent residents of the study area
  • Pregnant women live in a place ≥2 hours of walking distance from the nearest health facility and/or have no access to public transportation
  • Pregnant women whose husbands/male partners will be willing to participate in the study

You may not qualify if:

  • Pregnant women ≤ 13 weeks of gestation
  • Pregnant women not living with their male partners at the time of the study
  • Pregnant women who are not permanent residents of the study area
  • Pregnant women live in a place \< 2 hours of walking distance from the nearest health facility or have access to transportation
  • Pregnant women whose husbands are not willing to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jimma University

Jimma, Oromiya, 378, Ethiopia

RECRUITING

Related Publications (2)

  • Yarinbab TE, Gesesew HA, Belachew T. Effect of health education provided to couples on maternal knowledge, attitude and use of maternity waiting homes in rural Ethiopia: A cluster-randomized trial. Midwifery. 2024 Nov;138:104153. doi: 10.1016/j.midw.2024.104153. Epub 2024 Aug 22.

  • Yarinbab TE, Gesesew HA, Harrison MS, Belachew T. Effect of couple-based health education on male-partners knowledge and attitude towards maternity waiting homes in rural Ethiopia: a cluster-randomized trial. Sci Rep. 2023 Oct 27;13(1):18446. doi: 10.1038/s41598-023-45681-4.

MeSH Terms

Conditions

Maternal Death

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Parental DeathDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Teklemariam E Yarinbab, MPH

    Mizan Tepi University

    PRINCIPAL INVESTIGATOR
  • Hailay A Gesesew, PhD

    Torrens University Australia

    PRINCIPAL INVESTIGATOR
  • Tefera Belachew, PhD

    Jimma University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Teklemariam E Yarinbab, MPH

CONTACT

Tefera Belachew, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcome assessors will be masked.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: The study will have two arms, i.e., intervention and control groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 3, 2021

First Posted

August 20, 2021

Study Start

November 1, 2022

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

February 8, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

There is no plan to make IPD available.

Locations