Emergency Contraception (ECP): Reducing Unintended Pregnancies - Tabular View

Tracking Information

First Received Date ^ICMJE

August 21, 2003

Last Updated Date

June 23, 2005

Start Date ^ICMJE

June 2001

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00067509 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Emergency Contraception (ECP): Reducing Unintended Pregnancies

Official Title ^ICMJE

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

Brief 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.

Detailed 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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Non-Randomized, Open Label, Active Control, Factorial Assignment, Efficacy Study

Condition ^ICMJE

Contraception
Pregnancy

Intervention ^ICMJE

Drug: emergency contraception (estrogen/progesterone)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1100

Completion Date

May 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

15 Years to 39 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00067509

Responsible Party

Study ID Numbers ^ICMJE

HD38515

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Paul G Whittaker, D.Phil.

Information Provided By

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

Verification Date

July 2003

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP