Abortion Failure
Conditions
Keywords
mifepristone, misoprostol, medical abortion
Brief summary
The primary outcome of this study is to compare the effectiveness of a second complete course of 200 mg mifepristone and 800 mcg misoprostol for ongoing pregnancy following mifepristone-misoprostol medical abortion.
Detailed description
This is a multi-site double-blind, randomized controlled trial to assess treatment with a repeat mifepristone-misoprostol regimen and with a two-dose misoprostol-alone regimen in women who are diagnosed with ongoing pregnancy ≤77 days gestational age at 1-week follow-up after medical abortion. The sample will be stratified in two cohorts: women with ongoing pregnancies \<= 56 days of gestation and women with ongoing pregnancies 57-77 days of gestation. Eligible women who agree to participate in the study will be randomly assigned to either Group 1 for treatment with 200 mg mifepristone followed in 24-48 hours by 800 mcg buccal misoprostol, followed by 4 misoprostol placebo pills 3-12 hours later, or to Group 2 for treatment with one mifepristone placebo pill, followed by 800 mcg buccal misoprostol 24-48 hours later and another 800 mcg dose repeated in 3-12 hours. The study will also assess the acceptability of additional medication for ongoing pregnancy following an initial course of mifepristone-misoprostol medical abortion.
Interventions
DRUGMifepristone
200mg oral mifepristone
DRUGMisoprostol
800mcg buccal misoprostol
DRUGPlacebo mifepristone
Matching placebo pill of 200mg mifepristone
DRUGPlacebo misoprostol
Matching placebo pills of 800mcg misoprostol
Sponsors
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Have ultrasound evidence of an ongoing pregnancy (embryo with cardiac activity) \<= 77 days gestational age at follow-up after using a mifepristone-misoprostol regimen for termination of pregnancy * Agree to comply with study procedures * Able to consent to study participation
Exclusion criteria
* Have an ongoing pregnancy but did not take an initial course of mifepristone and misoprostol at the study site * Are \< 18 years old in US and Canadian sites * Present with other medical abortion outcomes including persistent non-viable pregnancies or empty sac * Are unable to provide contact information for follow-up purposes
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of women in each study group, by gestational age cohort, who have a successful abortion without recourse to surgical intervention for any reason. | One week after taking first study medication |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of women in each arm by gestational age cohort with resolved ongoing pregnancies following study treatment, regardless of surgical intervention | One week after taking first study medication |
| The proportion of women who found medical treatment to be an acceptable method to treat ongoing pregnancy, as measured by a follow up questionnaire | One week after taking first study medication |
Countries
United States
Outcome results
None listed