Clinical trial NCT01115361: Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services
Official title: Improving Access to and Uptake of Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Contraception
Keywords: family planning
postpartum
immunization
integration
Contraceptive behavior
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Rwanda
First posted: 2010-05-04
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

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 criteria: 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.

Primary outcomes:
measure: Use of a modern contraceptive method among postpartum women
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kigali
country: Rwanda
facility: Rwanda health care facilities
Study officials:
affiliation: FHI 360
name: Lisa S Dulli, PhD, MHS
role: PRINCIPAL_INVESTIGATOR
affiliation: FHI 360
name: Steve Sortijas, MPH
role: STUDY_DIRECTOR
affiliation: Ministry of Health, Rwanda
name: Fidèle Ngabo, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: