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

University of Pennsylvania

Status and phase: Completed; Phase 4

Conditions: Post Partum

Treatments: Drug: Plan B (Levonorgestrel)

Study type: Interventional

Funder types: Other

Identifiers

NCT00433004

805358

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: Female

Ages: 14 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1

No Intervention group

Description:

No advance supply of emergency contraception

2

Active Comparator group

Description:

Advance supply of emergency contraception is given

Treatment:

Drug: Plan B (Levonorgestrel)