Emergency Contraception (ECP): Reducing Unintended Pregnancies
Primary Purpose
Contraception, Pregnancy
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
emergency contraception (estrogen/progesterone)
Sponsored by

About this trial
This is an interventional prevention trial for Contraception focused on measuring Female
Eligibility Criteria
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
Sites / Locations
- Family Planning Council
- Family Health Council
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00067509
First Posted
August 21, 2003
Last Updated
June 23, 2005
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT00067509
Brief Title
Emergency Contraception (ECP): Reducing Unintended Pregnancies
Official Title
A Second Chance With Emergency Contraception (ECP): Reducing Unintended Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2003
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Contraception, Pregnancy
Keywords
Female
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1100 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
emergency contraception (estrogen/progesterone)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul G Whittaker, D.Phil.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Planning Council
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Family Health Council
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15222
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Emergency Contraception (ECP): Reducing Unintended Pregnancies
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