Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services (PPFP-IZ)

March 28, 2012 updated by: FHI 360

Improving Access to and Uptake of Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services

The purpose of this study is to determine the effectiveness of an intervention, which is designed to increase contraceptive prevalence among postpartum women attending vaccination services who desire to either space or limit their pregnancies, thus reducing unmet contraceptive need in this population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study Goal:

To determine the effectiveness of an intervention, which is designed to increase contraceptive prevalence among postpartum women attending vaccination services who desire to either space or limit their pregnancies, thus reducing unmet contraceptive need in this population.

The Intervention:

A. Brief, concise messages conveyed to women during group education sessions regarding pregnancy risk, benefits of FP, and family planning options during the postpartum period.

B.IEC materials such as posters and brochures that deliver messages about the benefits of spacing pregnancies by at least 2 years, LAM, return to fecundity and pregnancy risk during the postpartum period and contraceptive options for postpartum women.

C.Use of a screening tool (Appendix A) to assess pregnancy risk for postpartum women coupled with a brief counseling message depending upon risk classification which includes referral to FP services for those currently or soon-to-be at-risk of pregnancy.

D.Convenient offer of FP services to women attending vaccination services for their infants either concurrently with vaccination services, or at the same facility and on the same day, but at a different time from vaccination services.

Study Design:

Experimental, two-group (intervention/control) pretest (pre-intervention) /posttest (post-intervention) design 12 month intervention period. A mid-course collection of process data will also be conducted at 6 months to assess the degree to which the intervention is being implemented as intended and to provide an opportunity for corrective action if needed.

Participants: Women attending vaccination services for their infants, and vaccination and FP providers

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Rwanda
      • Kigali, Rwanda
        • Rwanda health care facilities

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Clients:

  • adult women, aged 21 years and older, or married women ages 18 to 20 who have achieved legal majority status by emancipation due to marriage,
  • bring their infants between the ages 6-12 months to immunization services at study sites

Providers:

  • all health care providers who currently provide immunization services to infants and/or family planning services within the selected facilities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PPFP in child immunization
Women attending immunization services for their infant will receive educational brochures, group education and individual counseling on the benefits of the health timing and spacing of births,, pregnancy risk and return to fertility during the extended postpartum period (12 months), and referral to family planning services for those who are interested.
Behavioral: Family planning for postpartum women

A.Group education sessions regarding pregnancy risk, benefits of FP, and family planning options during the postpartum period.

B. IEC materials that deliver messages about the benefits of spacing pregnancies by at least 2 years, LAM, return to fecundity and pregnancy risk during the postpartum period and contraceptive options for postpartum women.

C. Use of a screening tool to assess pregnancy risk for postpartum women coupled with a brief counseling message and referral to FP services.

D.Convenient offer of FP services to women attending vaccination services for their infants.
No Intervention: Control - Standard of care
The control arm will receive standard of care infant immunization services.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of a modern contraceptive method among postpartum women
Time Frame: 1 year
The outcome variable is a dichotomous variable - use of modern FP method: yes/no
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FHI 360

Collaborators

Ministry of Health, Rwanda

Investigators

  • Principal Investigator: Lisa S Dulli, PhD, MHS, FHI 360
  • Study Director: Steve Sortijas, MPH, FHI 360
  • Principal Investigator: Fidèle Ngabo, MD, MPH, Ministry of Health, Rwanda

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

May 3, 2010

First Posted (Estimate)

May 4, 2010

Study Record Updates

Last Update Posted (Estimate)

March 29, 2012

Last Update Submitted That Met QC Criteria

March 28, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 890028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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