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Phase 4 N=50 Randomized Health Services Research

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

Post Partum

Bottom Line

View on ClinicalTrials.gov: NCT00433004 ↗
Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. — 22; 16 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Plan B (Levonorgestrel) (Drug)
Age
Pediatric, Adult · 14+ yrs
Sex
Female
Sponsor
University of Pennsylvania
Primary completion
Oct 2010

Outcome Measures

OutcomeResultp-value
PRIMARY
ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR.		 22; 16 —
PRIMARY
PREGNANCY RATES		 8; 3 —
PRIMARY
PLAN B USE		 8; 12 —

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.

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
View full record on ClinicalTrials.gov →

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.

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