Clinical trial NCT00269568: Mifepristone at Same Time Multicenter Study
Official title: A Multicenter, Randomized Comparison of Mifepristone and Misoprostol Administered Simultaneously Versus 24 Hours Apart for Abortion Through 63 Days
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Abortion Seekers
Keywords: medical abortion
mifepristone
misoprostol
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2005-12-23
Enrollment: 1128
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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%

Detailed description: 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%.

Eligibility criteria: Inclusion Criteria:pregnancy equal to or less than 63 days at enrollment -

Exclusion Criteria:abnormal pregnancy diagnosed by ultrasound

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Primary outcomes:
measure: complete abortion rate
timeFrame: 5 weeks after treatment
Secondary outcomes:
measure: to compare complete abortion rates by gestational age
timeFrame: 5 weeks after treatment
measure: compare bleeding and side effect profiles
timeFrame: up to 5 weeks after treatment
measure: compare acceptability of the two regimens
timeFrame: 2 weeks after treatment
measure: compare the expression of EP3 receptor mRNA in cervical tissue 2 and 24 hours after mifepristone treatment to pretreatment control
timeFrame: up to 24 hours after treatment
measure: measure time to first ovulation
timeFrame: up to 10 weeks after treatment
measure: compare elapsed time to ovulation between treatment regimens
timeFrame: up to 10 weeks after treatment
measure: evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start
timeFrame: up to 12 weeks after treatment
measure: describe the prevalence of domestic violence in a medical abortion research population
timeFrame: at time of enrollment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital
state: Pennsylvania
Study officials:
affiliation: Universtity of Pittsburgh
name: Mitchell D Creinin, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. Obstet Gynecol. 2007 Apr;109(4):885-94. doi: 10.1097/01.AOG.0000258298.35143.d2.
citation: 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: 10.1016/j.contraception.2008.02.012. Epub 2008 May 6.