Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services

Contraception Clinical Trial

— PPFP-IZ  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01115361
• Other study ID #: 890028
• Status: Completed
• Phase: N/A
• First received: April 28, 2010
• Last updated: March 28, 2012
• Start date: February 2010
• Est. completion date: December 2011

Study information

• Verified date: March 2012
• Source: FHI 360
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardRwanda: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: December 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Contraception

Intervention

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.

Locations

Country	Name	City	State
Rwanda	Rwanda health care facilities	Kigali

Sponsors (2)

Lead Sponsor	Collaborator
FHI 360	Ministry of Health, Rwanda

Country where clinical trial is conducted

Rwanda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of a modern contraceptive method among postpartum women	The outcome variable is a dichotomous variable - use of modern FP method: yes/no	1 year	No