N/A
N=298
Trial of Immediate Versus Delayed Initiation of Transdermal Hormonal Contraception After Therapeutic Abortion
Abortion
Bottom Line
View on ClinicalTrials.gov: NCT00235547 ↗Enrolled (actual)
298
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants Who Use Patch After Abortion, by Study Arm — 36; 42 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- timing of initiation of transdermal patch after an abortion (Behavioral)
- Age
- Pediatric, Adult · 13+ yrs
- Sex
- Female
- Sponsor
- University of California, San Francisco
- Primary completion
- May 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Use Patch After Abortion, by Study Arm |
36; 42 | — |
| SECONDARY Number of Participants Who Were Using Effective Method at 6 Months Post-enrollment |
46; 49 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00235547). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.