NCT01115361

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 28, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 4, 2010

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

March 29, 2012

Status Verified

March 1, 2012

Enrollment Period

1.7 years

First QC Date

April 28, 2010

Last Update Submit

March 28, 2012

Conditions

Keywords

family planningpostpartumimmunizationintegrationContraceptive behavior

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

PPFP in child immunization

EXPERIMENTAL

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

Control - Standard of care

NO INTERVENTION

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

Interventions

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.

PPFP in child immunization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rwanda health care facilities

Kigali, Rwanda

Location

MeSH Terms

Conditions

Contraception Behavior

Interventions

Family Planning ServicesPostpartum Period

Condition Hierarchy (Ancestors)

Reproductive BehaviorBehavior

Intervention Hierarchy (Ancestors)

Community Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesReproductive Health ServicesReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Officials

  • Lisa S Dulli, PhD, MHS

    FHI 360

    PRINCIPAL INVESTIGATOR
  • Steve Sortijas, MPH

    FHI 360

    STUDY DIRECTOR
  • Fidèle Ngabo, MD, MPH

    Ministry of Health, Rwanda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2010

First Posted

May 4, 2010

Study Start

February 1, 2010

Primary Completion

October 1, 2011

Study Completion

December 1, 2011

Last Updated

March 29, 2012

Record last verified: 2012-03

Locations