Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00433004
Other study ID # 805358
Secondary ID
Status Completed
Phase Phase 4
First received February 8, 2007
Last updated December 1, 2016
Start date February 2007
Est. completion date October 2010

Study information

Verified date December 2016
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date October 2010
Est. primary completion date October 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 14 Years to 19 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
United States Hospital of University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1. ABILITY TO FOLLOW POSTPARTUM TEENS FOR 1 YEAR. 2. PREGNACY RATES 3. PLAN B USE 4. CONTRACEPTIVE USE/CONTINUATION 1 year No
See also
  Status Clinical Trial Phase
Recruiting NCT05521646 - Implementing Best Practice Postpartum Contraceptive Services Through a Quality Improvement Initiative N/A
Completed NCT04488276 - Effects of Second-hand Smoke on a Pregnant Woman
Completed NCT03247660 - Perineal Physiotherapy in Postpartum N/A
Not yet recruiting NCT04160273 - Evaluation of Postpartum Posttraumatic Stress Disorder at Angers University Hospital (ESPT-PP) N/A
Completed NCT00730704 - Acceptance of Human Papillomavirus Vaccination in Postpartum Women N/A
Completed NCT04550364 - MUMMIBODIES. Eating Disorders, Pregnancy and Post Partum Period.
Recruiting NCT05236023 - Family Centred Healthcare - Zero Separation and Couplet Care N/A
Completed NCT03353012 - Acceptability & Tolerance of Immediate Versus Delayed Postpartum Contraceptive Implant Phase 4
Active, not recruiting NCT04244279 - The Efficacy of Ergonomic Intervention in Preventing Musculoskeletal Disorders Among Women After Giving Birth N/A