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 260 women comparing misoprostol alone to mifepristone plus misoprostol for second trimester (14-21 weeks' LMP) medical abortion.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
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.
placebo resembling mifepristone followed 24 hours later by 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
placebo resembling mifepristone taken 24 hours before 800 mcg buccal misoprostol repeated every 3 hours until complete abortion or maximum of 5 doses.
National Ob-Gyn Hospital
Hanoi, Vietnam
Hung Vuong Hospital
Ho Chi Minh City, Vietnam
Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention.
Time frame: 24 hours
Rate of fetal expulsion: defined as fetal expulsion with study drug alone.
Time frame: 24 hours
Induction-to-abortion interval
Time frame: Time elapsed between administration of the first misoprostol dose until expulsion of the fetus.
Total dose of misoprostol.
Time frame: Assessed at time of complete abortion with study drug alone or when total maximum dose given.
Pain experienced by the woman as self-reported.
Time frame: Assessed during exit interview.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.