NCT03585361

Brief Summary

This study is investigating whether use of postpartum family planning (PPFP) increases if messages on PPFP and, if desired, PPFP services are integrated into as many contacts as possible between women/couples and the health system during pregnancy and the first year after birth. Health system contacts may be at health facilities (including antenatal, labor and delivery, postnatal, and child immunization visits) or, with Ethiopia's Health Extension Program, at households or health posts in the community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
776

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

6 active sites

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

February 20, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 29, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 13, 2018

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.3 years

First QC Date

June 29, 2018

Last Update Submit

July 16, 2018

Conditions

Keywords

Contraceptive UsagePregnancyPostpartum Family PlanningContraceptionPrenatal CarePostnatal CarePostpartum CareFamily PlanningEthiopiaCommunity Health WorkersCommunity Based CareHealth Extension Workers

Outcome Measures

Primary Outcomes (1)

  • PPFP uptake

    Proportion of interviewed postpartum women who used a modern family planning method within 12 months after giving birth

    12 months after birth

Secondary Outcomes (1)

  • Method choice

    12 months after birth

Study Arms (2)

Intervention

EXPERIMENTAL

Health centers provide PPFP counseling and services, implementing current Government of Ethiopia policy and standard of care (including still experimental screening and intra-facility referrals of women bringing infants for immunization). Also, health centers conduct data reviews of PPFP counseling, intra-facility referrals and uptake data. At community level, HEWs provide PPFP counseling and services throughout continuum of care, volunteers (Development Army) promote PPFP, and HEWs and volunteers track PPFP method choice and uptake.

Behavioral: Health centers provide PPFP counseling and servicesBehavioral: HEWs provide PPFP counseling and servicesBehavioral: Volunteers (Development Army) promote PPFPBehavioral: Health centers conduct data reviewsBehavioral: HEWs and volunteers track PPFP

Comparison

ACTIVE COMPARATOR

Health centers provide PPFP counseling and services, implementing current Government of Ethiopia policy and standard of care (including still experimental screening and intra-facility referrals of women bringing infants for immunization). Health centers conduct data reviews.

Behavioral: Health centers provide PPFP counseling and servicesBehavioral: Health centers conduct data reviews

Interventions

Providers trained on PPFP counseling skills and insertion technique for placing intrauterine devices (IUDs) immediately after birth with a refresher on insertion techniques for IUDs and implants. Training also included how to use tools to document PPFP services and referrals. Follow up supervision ensured skill mastery and retention.

ComparisonIntervention

HEWs trained in PPFP counseling with a refresher on implant insertion skills. Training also included how to use tools to document PPFP services, method choice, and pregnancy risk at every contact during pregnancy and up to 12 months after birth. Follow up supervision ensured skill improvement and retention.

Intervention

HEWs orient volunteers on promoting PPFP and how to use a pictoral tool to remind women to access ANC, immunization, and PPFP services and to document women's method preferences and pregnancy risk at every contact during pregnancy and up to 12 months after birth.

Intervention

Health center staff document PPFP counseling, provision, and referrals in registers and use a facility dashboard to display and track aggregate PPFP data.

ComparisonIntervention

HEWs and volunteers track PPFP counseling, choice of method, receipt of methods, and pregnancy risk starting in pregnancy through 12 months postpartum. HEWs and volunteers meet and review data.

Intervention

Eligibility Criteria

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

You may qualify if:

  • Women
  • Pregnant at time of enrollment
  • Willing to give informed consent
  • Provider interviews
  • Providers providing PPFP messages or services in study area
  • Willing to give informed consent

You may not qualify if:

  • Women
  • Not pregnant at time of enrollment
  • Living outside study area
  • Provider interviews
  • Not working in antenatal, labor \& delivery, postnatal, or immunization care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Boru PHCU

Hitosa, Oromiya, Ethiopia

Location

Sibu PHCU

Hitosa, Oromiya, Ethiopia

Location

Aleko PHCU

Lode Hitosa, Oromiya, Ethiopia

Location

Huruta PHCU

Lode Hitosa, Oromiya, Ethiopia

Location

Ligaba PHCU

Lode Hitosa, Oromiya, Ethiopia

Location

Lode Jimata

Lode Hitosa, Oromiya, Ethiopia

Location

Related Publications (1)

  • Pfitzer A, Jima GH, Sitrin D, Ayalew F, Ahmed S. Effect of multiple counselling contacts along the continuum of care on use of postpartum family planning in a cohort of Ethiopian women: a dose-response analysis. BMJ Open. 2024 Dec 20;14(12):e084247. doi: 10.1136/bmjopen-2024-084247.

MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2018

First Posted

July 13, 2018

Study Start

February 20, 2017

Primary Completion

May 30, 2018

Study Completion

May 30, 2018

Last Updated

July 18, 2018

Record last verified: 2018-07

Locations