Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235547
Status:
COMPLETED
Last Update Posted:
2019-08-29
First Post:
2005-10-06
Brief Title:
Trial of Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2019-08
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:
This is a randomized controlled trial investigating whether immediate versus standard Sunday Start initiation of transdermal hormonal contraception the patch in post-abortion subjects can improve compliance and the continuation of contraception Immediate initiation of the patch has been studied in women seeking contraception when they are not immediately post-abortion and this Quick Start method has been shown to improve the continuation of the patch into a second month The primary hypothesis of this study is that immediate initiation of the patch in post-abortal women will improve the continuation of contraception over delayed initiation on the first Sunday after an abortion
Detailed Description:
The United States has a higher rate of unintended pregnancy than Canada or any other developed nation in Europe Hormonal contraception is the most common method of contraception used in this country Perfect use can lead to failure rates as low as 01 per year Actual failure rates are much higher often due to non-compliance with contraception use Several recent studies have examined the Quick Start or initiation of hormonal contraception OCPs and patch in front of the provider while still at the clinic regardless of time in the cycle These studies have shown that women who placed the first patch in the clinic were more likely to continue the patch into the second month Women who are seen in clinics for a therapeutic abortion TAB are often at extremely high risk for another unintendedunwanted pregnancy If compliance in patch use could be improved in this group of women unintendedunwanted pregnancy rates could be reduced One concern about the Quick Start technique is that women may have already ovulated or conceived when the patch is initiated mid-cycle In the post-abortal setting this is not a concern Applying the Quick Start technique to post-abortion patients and having women place the first patch while still in the clinic after their abortion may improve compliance and continuation of patch use
This is a prospective randomized controlled trial in post-abortal women and will last approximately 24 months All of the study subjects will receive a months worth of the patch and a one-year prescription after their TAB The women in the immediate start arm will then place their first patch in the clinic observed by clinic staff before leaving The controls will be instructed to place the first patch on the first Sunday following their abortion All subjects will receive the same medication with the only difference being the timing of initiation of the patch Measurements of continuation will be determined by telephone interviews administered at two and six months after the subjects abortion
This is a prospective randomized controlled trial in post-abortal women and will last approximately 24 months All of the study subjects will receive a months worth of the patch and a one-year prescription after their TAB The women in the immediate start arm will then place their first patch in the clinic observed by clinic staff before leaving The controls will be instructed to place the first patch on the first Sunday following their abortion All subjects will receive the same medication with the only difference being the timing of initiation of the patch Measurements of continuation will be determined by telephone interviews administered at two and six months after the subjects abortion
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