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
|