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Emergency Contraception (ECP): Reducing Unintended Pregnancies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00067509
Recruitment Status : Completed
First Posted : August 25, 2003
Last Update Posted : June 24, 2005
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1100 participants
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 : June 2001
Study Completion Date : May 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Birth Control

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 39 Years   (Child, Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00067509

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United States, Pennsylvania
Family Planning Council
Philadelphia, Pennsylvania, United States, 19102
Family Health Council
Pittsburgh, Pennsylvania, United States, 15222
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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Principal Investigator: Paul G Whittaker, D.Phil.
Layout table for additonal information Identifier: NCT00067509    
Other Study ID Numbers: HD38515
First Posted: August 25, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: July 2003
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Additional relevant MeSH terms:
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Disease Attributes
Pathologic Processes
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs