Second Trimester Abortion
Conditions
Keywords
medical abortion, mifepristone
Brief summary
This pilot study seeks to evaluate the safety, acceptability and feasibility of a shortened outpatient procedure for medical abortion at 13-18 weeks gestation. It also seeks to document the roles of health workers in providing services related to later abortion care. Participants will take a single dose of 200 mg mifepristone orally, followed 24-48 hours later with 400 mcg misoprostol sublingually prior to arriving at the study clinic. Repeat doses of 400 mcg misoprostol will be administered sublingually every three hours at the clinic until the abortion is achieved. If expulsion does not occur by a certain time prior to the clinic closing that day, D&E will be performed to complete the abortion.
Interventions
DRUGMifepristone
One 200 mg pill (oral)
DRUGMisoprostol
Two 400 mcg pills (sublingual)
Sponsors
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Have an intrauterine pregnancy of 13-18 weeks gestation according to ultrasound 2. Meet legal criteria to obtain abortion 3. Be at least 18 years old 4. Have access to a phone where she can be reached for the 2-week follow up 5. Be willing to follow pilot study procedures
Exclusion criteria
1. Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol 2. Any contraindications to vaginal delivery 3. More than one prior cesarean delivery 4. Staying more than 2 hours away from the clinic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful medical abortion | 0-60 hours after mifepristone | Proportion of women who have a successful abortion with medication only and are discharged from care on the same day as misoprostol induction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Initiation-to-abortion interval | 0-60 hours after mifepristone | Time (median min/hrs) from mifepristone administration until fetal and placental expulsion |
| Total dose of misoprostol administered | 0-12 hours after misoprostol | Mean number of misoprostol doses administered to achieve abortion |
| Method safety | Two weeks after mifepristone | Proportion of participants who experience: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications |
| Tasks performed by clinic staff | From enrollment through discharge from care (approx. 3 days) | Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge) per cadre of provider |
| Induction-to-abortion interval | 0-12 hours after misoprostol | Time (median min/hrs) from first misoprostol dose until fetal and placental expulsion |
| Pain with procedure | 0-12 hours after first misoprostol dose | Mean pain score (scale 0-10) |
| Side effects | 0-12 hours after first misoprostol dose | Report of side effects and proportion of participants who experienced each one |
| Satisfaction with procedure | Prior to discharge from care on day of abortion, up to 12 hours after first misoprostol dose | Proportion of participants who reported the procedure as satisfactory or very satisfactory |
| Total clinic time | 0-12 hours from arrival at clinic on day of induction with misoprostol | Time (median hrs) since arrival to clinic on day of misoprostol dosing to discharge from care that same day |
Countries
Colombia
Outcome results
None listed