Emergency Contraception (ECP): Reducing Unintended Pregnancies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2004-05-31

Brief Summary

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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

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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.

Conditions

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Contraception Pregnancy

Keywords

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Female

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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emergency contraception (estrogen/progesterone)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Paul G Whittaker, D.Phil.

Role: PRINCIPAL_INVESTIGATOR

Locations

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Family Planning Council

Philadelphia, Pennsylvania, United States

Site Status

Family Health Council

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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HD38515

Identifier Type: -

Identifier Source: org_study_id