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Emergency Contraception (ECP): Reducing Unintended Pregnancies

This study has been completed.
Sponsor:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00067509
First received: August 21, 2003
Last updated: June 23, 2005
Last verified: July 2003
History of Changes

August 21, 2003
June 23, 2005
June 2001
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Complete list of historical versions of study NCT00067509 on ClinicalTrials.gov Archive Site
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Emergency Contraception (ECP): Reducing Unintended Pregnancies
A Second Chance With Emergency Contraception (ECP): Reducing Unintended Pregnancy

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.

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.
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Contraception
  • Pregnancy
Drug: emergency contraception (estrogen/progesterone)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1100
May 2004
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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
Female
15 Years to 39 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00067509
HD38515
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Paul G Whittaker, D.Phil.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
July 2003

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