NCT04780243

Brief Summary

This study is aimed to enhance postpartum family planning by integrating family planning information with infant immunization services, which is the most widely utilized health services globally.

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
1,474

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

January 30, 2021

Last Update Submit

March 1, 2021

Conditions

Contraceptive Usage

Outcome Measures

Primary Outcomes (1)

  • After the initiation of the intervention, improved Contraceptive prevalence rate will be expected as an outcome

    After counseling of the postpartum mothers for family planning, their informed decision making capacity to use contraceptives will be increased.

    the outcome is measured two months after the initiation of the intervention

Study Arms (2)

Pre-intervention group

NO INTERVENTION

Pre-intervention group: women participated during the base line assessment will be labeled as Pre-intervention group

postintervention group

EXPERIMENTAL

Postintervention group: women participated after the intervention was initiated will be labeled as postintervention group.

Other: counseling

Interventions

counselingOTHER

Mothers presented to infant immunization units are going to be counseled for family planning services and if decide to take any method, they will be linked to family planning services

postintervention group

Eligibility Criteria

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

You may qualify if:

  • all women visiting health facilities for infant immunization for at least two times will be included.

You may not qualify if:

  • Women who are in difficulty of communicating during the study period will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidama regional health bureau

Awasa, Sidama Region, Ethiopia

Location

MeSH Terms

Conditions

Contraception Behavior

Interventions

Counseling

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Abebaw Muluneh

    Hawassa University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Mr.

Study Record Dates

First Submitted

January 30, 2021

First Posted

March 3, 2021

Study Start

February 1, 2020

Primary Completion

August 30, 2020

Study Completion

March 17, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

ET(1)