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

Post Partum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00433004
• Other study ID #: 805358
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2007
• Last updated: December 1, 2016
• Start date: February 2007
• Est. completion date: October 2010

Study information

• Verified date: December 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 14 Years to 19 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Emergencies
• Post Partum

Intervention

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.

Locations

Country	Name	City	State
United States	Hospital of University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. 2. PREGNACY RATES 3. PLAN B USE 4. CONTRACEPTIVE USE/CONTINUATION		1 year	No