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Emergency Contraception (ECP): Reducing Unintended Pregnancies

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00067509
First Posted: August 25, 2003
Last Update Posted: December 9, 2005
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.
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  Purpose
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 Intervention Phase
Contraception Pregnancy Drug: emergency contraception (estrogen/progesterone) Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment: 1100
Study Start Date: June 2001
Estimated Study Completion Date: May 2004
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00067509


Locations
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)
Investigators
Principal Investigator: Paul G Whittaker, D.Phil.
  More Information

ClinicalTrials.gov Identifier: NCT00067509     History of Changes
Other Study ID Numbers: HD38515
First Submitted: August 21, 2003
First Posted: August 25, 2003
Last Update Posted: December 9, 2005
Last Verified: July 2003

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Female

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes
Progesterone
Estrogens
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs