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

Sponsor:	University of Pennsylvania
Information provided by:	University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00433004

Purpose

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.

Condition	Intervention	Phase
Post Partum	Drug: Plan B (Levonorgestrel)	Phase IV

Study Type:	Interventional
Study Design:	Health Services Research, Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	A Pilot Randomized Control Trial of Advanced Supply of Levonorgestrel Emergency Contraception vs. Routine Postpartum Contraceptive Care in the Teenage Population

Resource links provided by NLM:

MedlinePlus related topics: Birth Control Postpartum Care

Drug Information available for: Levonorgestrel

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:

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 ]

Estimated Enrollment:	50
Study Start Date:	February 2007
Estimated Study Completion Date:	February 2009
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: No Intervention No advance supply of emergency contraception
2: Active Comparator Advance supply of emergency contraception is given	Drug: Plan B (Levonorgestrel) PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRS ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.

Eligibility

Ages Eligible for Study:	14 Years to 19 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00433004

Locations

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

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator:

Courtney Schreiber, MD, MPH

University of Pennsylvania

More Information

No publications provided

Responsible Party:	University of Pennsylvania ( Courtney Schreiber, MD, MPH )
Study ID Numbers:	805358
Study First Received:	February 8, 2007
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00433004 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pennsylvania:

Teen
Plan B
Post Partum
Emergency Contraception

Additional relevant MeSH terms:

Disease Attributes
Pathologic Processes
Contraceptive Agents
Therapeutic Uses
Levonorgestrel
Contraceptives, Oral

Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Emergencies
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009