Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services

NCT ID: NCT01115361

Last Updated: 2012-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-12-31

Brief Summary

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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

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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

Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Family planning for postpartum women

Intervention Type BEHAVIORAL

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.

Control - Standard of care

The control arm will receive standard of care infant immunization services.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, Rwanda

OTHER_GOV

Sponsor Role collaborator

FHI 360

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lisa S Dulli, PhD, MHS

Role: PRINCIPAL_INVESTIGATOR

FHI 360

Steve Sortijas, MPH

Role: STUDY_DIRECTOR

FHI 360

Fidèle Ngabo, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Ministry of Health, Rwanda

Locations

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Rwanda health care facilities

Kigali, , Rwanda

Site Status

Countries

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Rwanda

Other Identifiers

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890028

Identifier Type: -

Identifier Source: org_study_id

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