Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00067509
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-08-21
Brief Title:
Emergency Contraception ECP Reducing Unintended Pregnancies
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Study Overview
Official Title:
A Second Chance With Emergency Contraception ECP Reducing Unintended Pregnancy
Status:
COMPLETED
Status Verified Date:
2003-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
ECPs can give women a second chance to prevent an unintended pregnancy that might arise because of lack or improperdefective 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None