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

Primary Purpose

Post Partum

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Plan B (Levonorgestrel)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Post Partum focused on measuring Teen, Plan B, Post Partum, Emergency Contraception

Eligibility Criteria

14 Years - 19 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital of University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

1

2

Arm Description

No advance supply of emergency contraception

Advance supply of emergency contraception is given

Outcomes

Primary Outcome Measures

ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.
PREGNANCY RATES
PLAN B USE

Secondary Outcome Measures

Full Information

First Posted
February 8, 2007
Last Updated
August 17, 2017
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00433004
Brief Title
Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens
Official Title
A Pilot Randomized Control Trial of Advanced Supply of Levonorgestrel Emergency Contraception vs. Routine Postpartum Contraceptive Care in the Teenage Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Partum
Keywords
Teen, Plan B, Post Partum, Emergency Contraception

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
No advance supply of emergency contraception
Arm Title
2
Arm Type
Active Comparator
Arm Description
Advance supply of emergency contraception is given
Intervention Type
Drug
Intervention Name(s)
Plan B (Levonorgestrel)
Intervention Description
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 Outcome Measure Information:
Title
ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.
Time Frame
1 year
Title
PREGNANCY RATES
Time Frame
1 year
Title
PLAN B USE
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Courtney Schreiber, MD, MPH
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital of University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

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

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