Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens
A Pilot Randomized Control Trial of Advanced Supply of Levonorgestrel Emergency Contraception vs. Routine Postpartum Contraceptive Care in the Teenage Population
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2007
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 8, 2007
CompletedFirst Posted
Study publicly available on registry
February 9, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
September 15, 2017
CompletedSeptember 15, 2017
August 1, 2017
3.7 years
February 8, 2007
May 11, 2017
August 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.
1 year
PREGNANCY RATES
1 year
PLAN B USE
1 year
Study Arms (2)
1
NO INTERVENTIONNo advance supply of emergency contraception
2
ACTIVE COMPARATORAdvance supply of emergency contraception is given
Interventions
PP TEENS ARE RANDOMIZED TO PLAN B + ROUTINE CONTRACETIVE CARE VS. ROUTINE CARE ALONE. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Allergy to levonorgestrel
- Current substance abuse
- Plans for relocation outside of Philadelphia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Arden McAllister
- Organization
- University of Pennsylvania
Study Officials
- PRINCIPAL INVESTIGATOR
Courtney Schreiber, MD, MPH
University of Pennsylvania
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2007
First Posted
February 9, 2007
Study Start
February 1, 2007
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
September 15, 2017
Results First Posted
September 15, 2017
Record last verified: 2017-08