Abortion Seekers Clinical Trial
— MASTOfficial title:
A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days
| Verified date | January 2016 |
| Source | University of Pittsburgh |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
This is a multicenter, randomized study. 564 healthy women, age 18 years or older, with an intrauterine pregnancy, and requesting a medical abortion, will be recruited to participate in this prospective clinical trial. This study will provide an evaluation of oral mifepristone 200 mg and vaginal misoprostol 800 mcg administered simultaneously in women up to 63 days gestation. The aims of the study are to compare the complete abortion rates, at 7 and 14 days after misoprostol administration, when using mifepristone 200 mg orally and misoprostol 800 mcg vaginally are administered simultaneously and 24 hours apart in women up to 63 days gestation. Assessment of side effects (nausea, vomiting, pain) as well as acceptability will be done using pre and post-study questionnaires, and visual analogue scales. Complete abortion rate within 24 hours is expected to be 90%
| Status | Completed |
| Enrollment | 1128 |
| Est. completion date | April 2006 |
| Est. primary completion date | April 2006 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria:pregnancy equal to or less than 63 days at enrollment - Exclusion Criteria:abnormal pregnancy diagnosed by ultrasound |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Northwestern University | Chicago | Illinois |
| United States | University of Southern California | Los Angeles | California |
| United States | Magee-Womens Hospital | Pittsburgh | Pennsylvania |
| United States | Oregon Health Sciences University | Portland | Oregon |
| Lead Sponsor | Collaborator |
|---|---|
| University of Pittsburgh |
United States,
Bednarek PH, Nichols MD, Carlson N, Edelman AB, Creinin MD, Truitt S, Jensen JT. Effect of "observed start" vs. traditional "Sunday start" on hormonal contraceptive continuation rates after medical abortion. Contraception. 2008 Jul;78(1):26-30. doi: 10.10 — View Citation
Creinin MD, Schreiber CA, Bednarek P, Lintu H, Wagner MS, Meyn LA; Medical Abortion at the Same Time (MAST) Study Trial Group. Mifepristone and misoprostol administered simultaneously versus 24 hours apart for abortion: a randomized controlled trial. Obst — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | complete abortion rate | 5 weeks after treatment | No | |
| Secondary | to compare complete abortion rates by gestational age | 5 weeks after treatment | No | |
| Secondary | compare bleeding and side effect profiles | up to 5 weeks after treatment | Yes | |
| Secondary | compare acceptability of the two regimens | 2 weeks after treatment | No | |
| Secondary | compare the expression of EP3 receptor mRNA in cervical tissue 2 and 24 hours after mifepristone treatment to pretreatment control | up to 24 hours after treatment | No | |
| Secondary | measure time to first ovulation | up to 10 weeks after treatment | No | |
| Secondary | compare elapsed time to ovulation between treatment regimens | up to 10 weeks after treatment | No | |
| Secondary | evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start | up to 12 weeks after treatment | No | |
| Secondary | describe the prevalence of domestic violence in a medical abortion research population | at time of enrollment | No |