Viewing Study NCT01115361


Ignite Creation Date: 2025-12-24 @ 12:36 PM
Ignite Modification Date: 2025-12-27 @ 4:15 PM
Study NCT ID: NCT01115361
Status: COMPLETED
Last Update Posted: 2012-03-29
First Post: 2010-04-28
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services
Sponsor: FHI 360
Organization:

Study Overview

Official Title: Improving Access to and Uptake of Postpartum Family Planning Service Through Enhanced Family Planning in Immunization Services
Status: COMPLETED
Status Verified Date: 2012-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: PPFP-IZ
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

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: