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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00433004
First Posted: February 9, 2007
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Pennsylvania
  Purpose
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.

Condition Intervention Phase
Post Partum Drug: Plan B (Levonorgestrel) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. [ Time Frame: 1 year ]
  • PREGNANCY RATES [ Time Frame: 1 year ]
  • PLAN B USE [ Time Frame: 1 year ]

Enrollment: 50
Study Start Date: February 2007
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
No advance supply of emergency contraception
Active Comparator: 2
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. QUESTIONNAIRES ON HEALTH STATUS, SEXUAL HISTORY, AND CONTRACEPTIVE USE ARE COMPLETED AT STATED INTERVALS.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00433004     History of Changes
Other Study ID Numbers: 805358
First Submitted: February 8, 2007
First Posted: February 9, 2007
Results First Submitted: May 11, 2017
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017
Last Verified: August 2017

Keywords provided by University of Pennsylvania:
Teen
Plan B
Post Partum
Emergency Contraception

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Synthetic
Contraceptives, Oral