CompletedNot Applicable

Trial of Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion

United States298 participantsStarted 2005-08

Plain-language 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.

Who can participate

Age range

13 Years – 45 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any woman aged 13-45 who presents to the Women's Options Clinic and desires to use the patch for post-abortion contraception. Exclusion Criteria: * Gestational age above 23 weeks and 1 day. * Any absolute contraindication for patch use (smoking \> 20 cigarettes a day over age 35, history of venous thromboembolic event or pulmonary embolism, history of or current ischemic heart disease, history of stroke, vascular disease, complicated valvular heart disease \[pulmonary hypertension, atrial fibrillation, history of subacute bacterial endocarditis\], severe hypertension with blood pressure \>160/100, migraines with focal neurologic symptoms, current breast cancer, active viral hepatitis, severe cirrhosis, or benign or malignant liver tumors). * Patients who speak languages other than English or Spanish. * Patients who do not have a phone or who have a phone where any contact might compromise the confidentiality of their abortions.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Who Use Patch After Abortion, by Study Arm

Timeframe: six months after enrollment/abortion

Trial details

NCT IDNCT00235547

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-05

Results submitted2019-03-06

View on ClinicalTrials.gov More Abortion trials