Phase 4
Completed N=50
Advance Supply of Emergency Contraception Compared to Routine Postpartum Care in Teens
Post Partum
Source: ClinicalTrials.gov NCT00433004 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcomePrimary: ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. — 22; 16 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. |
22; 16 | — |
| PRIMARY PREGNANCY RATES |
8; 3 | — |
| PRIMARY PLAN B USE |
8; 12 | — |
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
Data sourced from ClinicalTrials.gov (NCT00433004). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.