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Emergency Contraception (ECP): Reducing Unintended Pregnancies



Emergency Contraception (ECP): Reducing Unintended Pregnancies

For Condition: Pregnancy,Contraception
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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.
Details: 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:
Study Type:
  Interventional,Prevention,Non-Randomized,Open Label,Active Control,Factorial Assignment,Efficacy Study
Minimum Age/Maximum Age: 15 Years/39 Years
Genders: Female
Protocol Entry 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
Total Enrollment: 1100

Location and Contact Information:

Overall Study Official:
PaulWhittaker,  Principal Investigator, 

Family Health Council
Pittsburgh,  Pennsylvania,  15222
United States
 

Family Planning Council
Philadelphia,  Pennsylvania,  19102
United States
 


Additional Information:
Study ID Numbers:
  HD38515; 
Study Start Date: June 2001
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00067509

Other Contraception Studies:
1. Fortovase (Saquinavir) Given with Low-Dose Ritonavir, Zidovudine, and Lamivudine to HIV-Positive Pregnant Women During and After Pregnancy and to Their Newborns

2. Maternal glucose measurement in pregnancy using a continuous ambulatory subcutaneous monitor

3. Study for Future Families

4. Study of Perinatal Transmission of Zidovudine-Resistant HIV Among Pregnant Women Treated with Zidovudine

5. Active Immunization of HIV-1 Infected, Pregnant Women With CD4 Lymphocyte Counts >= 400/mm3: A Phase I Study of Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine (NOTE: Some Patients Receive Placebo)

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Emergency Contraception (ECP): Reducing Unintended Pregnancies

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