Abortion, Induced
Conditions
Keywords
Pregnancy termination, abortion, medical abortion, 2nd trimester, mifepristone, misoprostol
Brief summary
The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized controlled double-blinded trial of 120 women in each country comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
Interventions
single dose of 200 mg mifepristone followed 24 hours later by 800 mcg misoprostol administered buccally and repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
DRUGmisoprostol+placebo
placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours for a maximum of 5 doses per 24 hours up to 48 hours.
Sponsors
Gynuity Health Projects
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* 14 to 21 weeks gestation, based on menstrual history and clinical exam (with or without ultrasound) * Meet legal criteria to obtain abortion * Present with closed cervical os and no vaginal bleeding * Live fetus at time of presentation for service * Have no contraindications to study procedures, according to provider * Be able to consent to procedure, either by reading consent document or by having consent document read to her * Be willing to follow study procedures
Exclusion criteria
* Known previous transmural uterine incision * Known allergy to mifepristone or misoprostol/prostaglandin or other contraindications to the use of mifepristone or misoprostol * Any contraindications to vaginal delivery, including placenta previa * Presentation in active labor (defined as moderate to severe contractions every 10 minutes or less)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention. | 48 hours |
| Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus. | 48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Total dose of misoprostol. | Assessed at time of complete abortion with study drug alone or when total maximum dose given. |
| Provision of additional interventions to manage excessive blood loss | from start of treatment until discharge |
| Women's acceptability of the assigned method | Assessed at exit interview |
| Pain experienced by the woman as self-reported. | Assessed during exit interview. |
| Any heavy bleeding, uterine rupture, or infection requiring additional treatment | start of treatment until discharge |
Countries
Moldova, Tunisia
Outcome results
None listed