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

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ClinicalTrials.gov Identifier: NCT00433004
Recruitment Status : Completed
First Posted : February 9, 2007
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment Phase
Post Partum Drug: Plan B (Levonorgestrel) Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
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
Study Start Date : February 2007
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Arms and Interventions
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Arm Intervention/treatment
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.


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

Eligibility Criteria
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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
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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
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United States, Pennsylvania
Hospital of University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Courtney Schreiber, MD, MPH University of Pennsylvania
More Information
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00433004    
Other Study ID Numbers: 805358
First Posted: February 9, 2007    Key Record Dates
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:
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Emergencies
Disease Attributes
Pathologic Processes
Levonorgestrel
Contraceptive Agents, Hormonal
Contraceptive Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic
Contraceptives, Oral