Medical Abortion
Conditions
Keywords
mifepristone, misoprostol, first trimester, abortion
Brief summary
This study seeks to evaluate the efficacy, side effect profile and acceptability of a medical abortion regimen with mifepristone and two doses of 800 mcg misoprostol buccally at 71-77 and 78-84 days of gestation to further expand the evidence base for the most effective regimens in the late first trimester of pregnancy.
Interventions
DRUGMifepristone + 2 doses of misoprostol 800 mcg
Will use a mifepristone-misoprostol regimen of: 200 mg mifepristone followed in 24-48 hours by a first dose of 800 µg misoprostol buccally and then in another 4 hours by a second dose of 800 µg misoprostol buccally. For buccal administration of misoprostol, participants will place 2 misoprostol tablets in each cheek and hold them for 20-30 minutes, after which they will swallow any remnants.
Sponsors
Society of Family Planning
Gynuity Health Projects
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
11 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Seeking medical abortion services at one of the enrolling clinics * Have an intrauterine pregnancy 71-77 days of gestation or 78-84 days * Meet standard eligibility criteria for medical abortion * Be able to return to clinic for in-person follow up * Speak/read/write English or Spanish * Have access to a mobile phone with texting capability * Be in general good health * Be willing and able to sign consent forms * Agree to comply with the study procedures and follow up.
Exclusion criteria
* Not eligible to consent on their own to being in a study (Age criteria may vary by site according to state law.) * With known allergies or other contraindications to mifepristone or misoprostol * Desiring to start depot medroxyprogesterone acetate (DMPA) as contraception method immediately because of potential interaction with mifepristone. Those who wish to wait until abortion completion to start DMPA will be eligible for enrollment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy as determined by the proportion of successful abortions without aspiration or D&E for any reason | 7-36 days after initial visit | Proportion of women who achieve complete abortion with medication only and without aspiration or D&E |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who report each individual side effect | 7-14 days after initial visit | Side effects include diarrhea, nausea, vomiting, fever, chills |
| Proportion of complications experienced by participants that warrant visits to emergency room and/or hospitalization | 7-14 days after initial visit | Complications could include abnormal bleeding, severe pain, retained tissue |
| Proportion of participants who determine method acceptable | 7-36 days after initial visit | Overall acceptability, time to complete abortion, bleeding, side effects, pain |
Countries
United States
Outcome results
None listed