Emergency Contraception (ECP): Reducing Unintended Pregnancies

Pregnancy Clinical Trial

Official title:

A Second Chance With Emergency Contraception (ECP): Reducing Unintended Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067509
• Other study ID #: HD38515
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2003
• Last updated: June 23, 2005
• Start date: June 2001
• Est. completion date: May 2004

Study information

• Verified date: July 2003
• Source: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

Emergency contraception is a method of birth control that can be used up to three days after sexual intercourse. Emergency contraceptive pills (ECPs) can be given to a woman before she needs them (advance provision) or when she needs them (emergency provision). This study will compare these two methods of providing ECPs.

Description:

ECPs can give women a “second chance” to prevent an unintended pregnancy that might arise because of lack or improper/defective use of contraceptives. By using ECP, a woman can reduce her risk of pregnancy by at least 75%; however, there is little information on what distribution patterns and other factors are most likely to encourage ECP use. This study will compare the use and cost of two ECP distribution patterns: advance provision and emergency provision. It will also identify environmental, situational, and behavioral factors associated with ECP acceptance and use.

Participants in this study will be recruited from four family planning clinics in the Philadelphia area and five family planning clinics in the Pittsburgh area. Participants from the Philadelphia clinics will be given ECPs as part of a regular clinic visit (advance provision); participants from the Pittsburgh clinics will be given ECPs on an emergency basis (emergent provision). Each participant will complete a short intake form and will be issued a pager. Participants will be paged every month over an 18-month period as a reminder to respond to a short automated telephone survey on ECP, contraceptives, and pregnancy status. Approximately half of the participants will be randomly selected to participate in in-depth interviews at study entry and Months 9 and 18. Clinic visit data will augment the surveys to verify use of the clinic and contraceptive method and to develop cost data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1100
• Est. completion date: May 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 39 Years

Eligibility

Inclusion Criteria

• Patient at a participating clinic

Exclusion Criteria

• Pregnant

• Medical or surgical procedure preventing pregnancy (e.g., tubal ligation, hysterectomy)

• Norplant or IUDs

• Desires to become pregnant

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception
• Pregnancy

Intervention

Drug:
• emergency contraception (estrogen/progesterone)

Locations

Country	Name	City	State
United States	Family Planning Council	Philadelphia	Pennsylvania
United States	Family Health Council	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States,