Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services (PPFP-IZ)
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Contraception |
Behavioral: Family planning for postpartum women |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
| Official Title: | Improving Access to and Uptake of Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services |
- Use of a modern contraceptive method among postpartum women [ Time Frame: 1 year ] [ Designated as safety issue: No ]The outcome variable is a dichotomous variable - use of modern FP method: yes/no
| Estimated Enrollment: | 800 |
| Study Start Date: | February 2010 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| Rwanda | |
| Rwanda health care facilities | |
| Kigali, Rwanda | |
| Principal Investigator: | Lisa S Dulli, PhD, MHS | FHI 360 |
| Study Director: | Steve Sortijas, MPH | FHI 360 |
| Principal Investigator: | Fidèle Ngabo, MD, MPH | Rwanda Ministry of Health |
More Information
No publications provided
| Responsible Party: | FHI 360 |
| ClinicalTrials.gov Identifier: | NCT01115361 History of Changes |
| Other Study ID Numbers: | 890028 |
| Study First Received: | April 28, 2010 |
| Last Updated: | March 28, 2012 |
| Health Authority: | United States: Institutional Review Board Rwanda: Ethics Committee |
Keywords provided by FHI 360:
|
family planning postpartum immunization integration Contraceptive behavior |
ClinicalTrials.gov processed this record on May 19, 2013