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.
Brief Title
Non-surgical Alternatives to Treatment of Failed 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.
The study will also assess the acceptability of additional medication for ongoing pregnancy following an initial course of mifepristone-misoprostol medical abortion.
Completion Date
Completion Date Type
Actual
Conditions
Abortion Failure
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
Female
Gender Based
false
Keywords
mifepristone
misoprostol
medical abortion
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT02704481
Org Class
Other
Org Full Name
Gynuity Health Projects
Org Study Id
1035
Overall Status
Terminated
Phases
Phase 4
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Non-surgical Alternatives to Treatment of Failed Medical Abortion: A Randomized Controlled Double-blind Trial
Primary Outcomes
Outcome Measure
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.
Outcome Time Frame
One week after taking first study medication
Secondary Outcomes
Outcome Time Frame
One week after taking first study medication
Outcome Measure
The proportion of women in each arm by gestational age cohort with resolved ongoing pregnancies following study treatment, regardless of surgical intervention
Outcome Time Frame
One week after taking first study medication
Outcome Measure
The proportion of women who found medical treatment to be an acceptable method to treat ongoing pregnancy, as measured by a follow up questionnaire
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Marji Gold
Investigator Email
MGOLD@montefiore.org
Investigator Phone
212-366-9320
MeSH Terms
MIFEPRISTONE
MISOPROSTOL
ESTRENES
ESTRANES
STEROIDS
FUSED-RING COMPOUNDS
POLYCYCLIC COMPOUNDS
PROSTAGLANDINS E, SYNTHETIC
PROSTAGLANDINS, SYNTHETIC
PROSTAGLANDINS
EICOSANOIDS
FATTY ACIDS, UNSATURATED
FATTY ACIDS
LIPIDS
AUTACOIDS
INFLAMMATION MEDIATORS
BIOLOGICAL FACTORS