Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) in Ethiopia

Pregnancy Clinical Trial

Official title:

Utilizing All Health System Contacts to Offer Postpartum Family Planning (PPFP) to Pregnant Women and Women Within Twelve Months Postpartum in Ethiopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03585361
• Other study ID #: IRB00007143
• Status: Completed
• Phase: N/A
• Start date: February 20, 2017
• Est. completion date: May 30, 2018

Study information

• Verified date: July 2018
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This implementation research study used a quasi-experimental, mixed method design with two arms. Two districts in Arsi Zone in Ethiopia's Oromia Region (Hitosa and Lode Hitosa) were selected for the study. In each district, one primary health care unit (PHCU) - a public health center and its satellite health posts - was randomly assigned to the intervention arm and one to the comparison arm.

PPFP counseling, services, and documentation were strengthened through training and supervision at health centers in both intervention and comparison PHCUs, consistent with Government of Ethiopia policies and guidelines. Only the intervention arm received the community-based intervention. The community-based intervention involved training Health Extension Workers (HEWs) who staff health posts, make outreach home visits, and support volunteers under the government's Development Army. HEWs were trained on PPFP with a refresher on implant insertion. The community invention also involved giving tools to HEWs and volunteers to help them track women's PPFP preferences and pregnancy risk.

The study objectives are to:

1. Assess the effect of systematically integrating PPFP messages into contacts with the health system on uptake of PPFP through 12 months postpartum using a 'dose-response' analysis based on the number of contacts

2. Estimate the added effect of the community-based intervention by comparing uptake of PPFP through 12 months postpartum in intervention and comparison sites

3. Explore the acceptability and feasibility of tracking PPFP and reviewing data at health centers and HEWs and volunteers using record keeping and review processes to track women's decision-making and contraceptive use from pregnancy through 12 months postpartum

4. Explore factors influencing women's/couples' adoption of PPFP during the first 12 months postpartum.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 776
• Est. completion date: May 30, 2018
• Est. primary completion date: May 30, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Women

• Pregnant at time of enrollment

• Willing to give informed consent

2. Provider interviews

• Providers providing PPFP messages or services in study area

• Willing to give informed consent

Exclusion Criteria:

1. Women

• Not pregnant at time of enrollment

• Living outside study area

2. Provider interviews

• Not working in antenatal, labor & delivery, postnatal, or immunization care

Related Conditions & MeSH terms

• Contraception
• Contraceptive Usage
• Postpartum Family Planning
• Pregnancy
• Prenatal Care

Intervention

Behavioral:
• Health centers provide PPFP counseling and services
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.
• HEWs provide PPFP counseling and services
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.
• Volunteers (Development Army) promote PPFP
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.
• Health centers conduct data reviews
Health center staff document PPFP counseling, provision, and referrals in registers and use a facility dashboard to display and track aggregate PPFP data.
• HEWs and volunteers track PPFP
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.

Locations

Country	Name	City	State
Ethiopia	Boru PHCU	Hitosa	Oromia
Ethiopia	Sibu PHCU	Hitosa	Oromia
Ethiopia	Aleko PHCU	Lode Hitosa	Oromia
Ethiopia	Huruta PHCU	Lode Hitosa	Oromia
Ethiopia	Ligaba PHCU	Lode Hitosa	Oromia
Ethiopia	Lode Jimata	Lode Hitosa	Oromia

Sponsors (3)

Lead Sponsor	Collaborator
Jhpiego	Bill and Melinda Gates Foundation, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Ethiopia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Method choice	Proportion of interviewed postpartum women who chose a method prior to delivery	12 months after birth