Abortion in Second Trimester
Conditions
Brief summary
This study seeks to evaluate the safety, acceptability and feasibility of an outpatient day procedure for medical abortion at 13-18 weeks gestation. The study regimen will consist of a single dose of 200 mg mifepristone to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally every three hours until the abortion is achieved.
Interventions
A single dose of 200 mg mifepristone (one tablet) to be taken orally either at home or at the hospital, followed 24-48 hours later with 400mcg misoprostol (buccal) at home. The participant will return to the hospital one to two hours after taking the initial dose of misoprostol to receive repeated doses of 400 mcg misoprostol until the abortion occurs.
Sponsors
CREHPA
Kathmandu Medical College and Teaching Hospital
Kathmandu Model Hospital
KIST Medical College
Gynuity Health Projects
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* Have an ongoing pregnancy of 13-18 weeks gestation * Meet legal criteria to obtain an abortion at 13-18 weeks gestation (legal criteria include pregnancy resulting from rape or incest, fetal malformation and/or if the pregnancy affects the physical or mental health of the woman) * Has access to a phone where she can be reached at the 2-week follow-up * Be willing to follow study procedures
Exclusion criteria
* Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol * Any contraindications to vaginal delivery * More than one prior cesarean delivery * Living more than 2 hours away from the hospital
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful medical abortion | 0 - 48 hours after first dose of mifepristone | Proportion of women who have a successful medical abortion without recourse to surgical intervention and return home on the same day as misoprostol induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total dose of misoprostol | 0 - 48 hours after first misoprostol dose | Average number of doses of misoprostol |
| Safety - Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications | 2 weeks after initial visit | Proportion of participants who experience at least one of the following: extramural delivery, hemorrhage requiring transfusion, infection, uterine rupture, prolonged hospitalization, any complications |
| Tasks performed by certified staff | 0 - 72 hours after receipt of mifepristone | Type of task performed (i.e. counseling, monitoring vital signs, administering drugs, monitoring woman's condition, post-abortion contraception, managing discharge) |
| Induction-to-abortion interval | 0 - 48 hours after first misoprostol dose | Median time elapsed between administration of the first misoprostol dose until expulsion of both fetus and placenta |
| Side Effects | 0 - 48 hours after first dose of misoprostol | Proportion of participants experiencing side effects (severity incidence, and severity of pain based on a 0-10 point scale) |
| Initiation-to-abortion interval | 0 - 72 hours after receipt of mifepristone | Median time elapsed between administration of the mifepristone dose until expulsion of both fetus and placenta |
| Hospital admission time | Within 0 - 48 hours after the second dose of misoprostol | Average total hospital admission time |
Countries
Nepal
Outcome results
None listed