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Completed

NCT Number: NCT00433004

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

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.

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Key information

Conditions

Post Partum

Age range

14 year–19 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Hospital of University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plan B (Levonorgestrel)

Drug

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.

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Feb 9, 2007
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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