Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens
Information source: University of Pennsylvania
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Post Partum
Intervention: Plan B (Levonorgestrel) (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: University of Pennsylvania
Official(s) and/or principal investigator(s):
Courtney Schreiber, MD, MPH, Principal Investigator, Affiliation: University of Pennsylvania
This is a pilot randomized controlled trial to asses 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.
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: Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment
Primary outcome: 1. ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.
2. PREGNACY RATES
3. PLAN B USE
4. CONTRACEPTIVE USE/CONTINUATION
Minimum age: 14 Years.
Maximum age: 19 Years.
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
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
Starting date: February 2007
Ending date: February 2009
Last updated: January 3, 2008