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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-10-31

Brief Summary

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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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Detailed Description

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Conditions

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Post Partum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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1

No advance supply of emergency contraception

Group Type NO_INTERVENTION

No interventions assigned to this group

2

Advance supply of emergency contraception is given

Group Type ACTIVE_COMPARATOR

Plan B (Levonorgestrel)

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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