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Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services (PPFP-IZ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01115361
First Posted: May 4, 2010
Last Update Posted: March 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Ministry of Health, Rwanda
Information provided by (Responsible Party):
FHI 360
  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: None (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

Resource links provided by NLM:


Further study details as provided by FHI 360:

Primary Outcome Measures:
  • Use of a modern contraceptive method among postpartum women [ Time Frame: 1 year ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01115361


Locations
Rwanda
Rwanda health care facilities
Kigali, Rwanda
Sponsors and Collaborators
FHI 360
Ministry of Health, Rwanda
Investigators
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

Responsible Party: FHI 360
ClinicalTrials.gov Identifier: NCT01115361     History of Changes
Other Study ID Numbers: 890028
First Submitted: April 28, 2010
First Posted: May 4, 2010
Last Update Posted: March 29, 2012
Last Verified: March 2012

Keywords provided by FHI 360:
family planning
postpartum
immunization
integration
Contraceptive behavior

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs