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Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens

Information source: University of Pennsylvania
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Post Partum

Intervention: Plan B (Levonorgestrel) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of Pennsylvania

Official(s) and/or principal investigator(s):
Courtney Schreiber, MD, MPH, Principal Investigator, Affiliation: University of Pennsylvania

Summary

This is a pilot randomized controlled trial to assess the effects of advanced supply of emergency contraception versus routine care in a teen postpartum population. The goals are to assess feasibility of recruiting and retaining postpartum teens; to obtain estimates of the prevalence of (use of Plan B, primary contraceptive continuation, unprotected intercourse exposure, and pregnancy rates), in postpartum teens given advanced supply of Plan B; to assess whether or not (lack of use of Plan B, contraceptive method non-continuation, and unprotected intercourse exposure), are surrogate markers for risk of unintended pregnancy.

Clinical Details

Official title: A Pilot Randomized Control Trial of Advanced Supply of Levonorgestrel Emergency Contraception vs. Routine Postpartum Contraceptive Care in the Teenage Population

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Primary outcome: 1. ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. 2. PREGNACY RATES 3. PLAN B USE 4. CONTRACEPTIVE USE/CONTINUATION

Eligibility

Minimum age: 14 Years. Maximum age: 19 Years. Gender(s): Female.

Criteria:

Inclusion Criteria: 1. Female 2. English speaking 3. Aged 14-19 at enrollment 4. Immediately postpartum of a live infant 5. Planning to parent the baby 6. Desiring to delay another pregnancy for at least one year 7. General good health 8. Willing and able to follow the study protocol Exclusion Criteria 1. Allergy to levonorgestrel 2. Current substance abuse 3. Plans for relocation outside of Philadelphia

Locations and Contacts

Hospital of University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States
Additional Information

Starting date: February 2007
Last updated: August 8, 2011

Page last updated: August 23, 2015

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