Abortion Seekers
Conditions
Keywords
medical abortion, mifepristone, misoprostol
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%.
Interventions
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
pregnancy equal to or less than 63 days at enrollment -
Exclusion criteria
abnormal pregnancy diagnosed by ultrasound \-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete abortion rate | 5 weeks after treatment |
Secondary
| Measure | Time frame |
|---|---|
| compare acceptability of the two regimens | 2 weeks after treatment |
| 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 |
| measure time to first ovulation | up to 10 weeks after treatment |
| compare bleeding and side effect profiles | up to 5 weeks after treatment |
| evaluate continuation rates of combined hormonal contraceptives in women with immediate initiation versus traditional Sunday start | up to 12 weeks after treatment |
| to compare complete abortion rates by gestational age | 5 weeks after treatment |
| describe the prevalence of domestic violence in a medical abortion research population | at time of enrollment |
| compare elapsed time to ovulation between treatment regimens | up to 10 weeks after treatment |
Countries
United States
Outcome results
None listed