Emergency Contraception (ECP): Reducing Unintended Pregnancies
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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 Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | A Second Chance With Emergency Contraception (ECP): Reducing Unintended Pregnancy |
| Estimated Enrollment: | 1100 |
| Study Start Date: | June 2001 |
| Estimated Study Completion Date: | May 2004 |
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| Ages Eligible for Study: | 15 Years to 39 Years |
| Genders 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
Contacts and Locations| United States, Pennsylvania | |
| Family Planning Council | |
| Philadelphia, Pennsylvania, United States, 19102 | |
| Family Health Council | |
| Pittsburgh, Pennsylvania, United States, 15222 | |
| Principal Investigator: | Paul G Whittaker, D.Phil. |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00067509 History of Changes |
| Other Study ID Numbers: | HD38515 |
| Study First Received: | August 21, 2003 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
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 Estrogens Progesterone |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Progestins |
ClinicalTrials.gov processed this record on June 18, 2013