Emergency Contraception (ECP): Reducing Unintended Pregnancies

Sponsor

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

Overall Status

Completed

CT.gov ID

NCT00067509

Collaborator

(none)

1,100

Enrollment

Locations

Duration (Months)

550

Patients Per Site

15.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception Pregnancy	Drug: emergency contraception (estrogen/progesterone)	Phase 4

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Jun 1, 2001

Study Completion Date :

May 1, 2004

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 39 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Family Planning Council	Philadelphia	Pennsylvania	United States	19102
2	Family Health Council	Pittsburgh	Pennsylvania	United States	15222

Sponsors and Collaborators

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

Investigators

Principal Investigator: Paul G Whittaker, D.Phil.,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00067509

Other Study ID Numbers:

HD38515

First Posted:

Aug 25, 2003

Last Update Posted:

Jun 24, 2005

Last Verified:

Jul 1, 2003

Keywords provided by , ,

Female

Additional relevant MeSH terms:

Emergencies

Progesterone

Estrogens

Study Results

No Results Posted as of Jun 24, 2005