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

Tracking Information

First Received Date ^ICMJE

February 8, 2007

Last Updated Date

February 20, 2009

Start Date ^ICMJE

February 2007

Estimated Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

1. ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. 2. PREGNACY RATES 3. PLAN B USE 4. CONTRACEPTIVE USE/CONTINUATION [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00433004 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment

Condition ^ICMJE

Post Partum

Intervention ^ICMJE

Drug: Plan B (Levonorgestrel)

Study Arms / Comparison Groups

No Intervention: No advance supply of emergency contraception
Active Comparator: Advance supply of emergency contraception is given

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

February 2009

Estimated Primary Completion Date

June 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

female
English speaking
Aged 14-19 at enrollment
Immediately postpartum of a live infant
Planning to parent the baby
Desiring to delay another pregnancy for at least one year
General good health
Willing and able to follow the study protocol

Exclusion Criteria

allergy to levonorgestrel
current substance abuse
plans for relocation outside of Philadelphia

Gender

Female

Ages

14 Years to 19 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00433004

Responsible Party

Courtney Schreiber, MD, MPH, University of Pennsylvania

Study ID Numbers ^ICMJE

805358

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Courtney Schreiber, MD, MPH

University of Pennsylvania

Information Provided By

University of Pennsylvania

Verification Date

February 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP