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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
238
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.
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.
Municipal Clinical Hospital
Chishinau, Moldova
La Rabta Maternity Hospital
Tunis, Tunisia
Rate of successful abortion: defined as complete evacuation using study drug without recourse to any additional intervention.
Time frame: 48 hours
Induction-to-abortion interval: defined as time elapsed between administration of the first misoprostol dose until expulsion of the fetus.
Time frame: 48 hours
Provision of additional interventions to manage excessive blood loss
Time frame: from start of treatment until discharge
Any heavy bleeding, uterine rupture, or infection requiring additional treatment
Time frame: start of treatment until discharge
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.
Women's acceptability of the assigned method
Time frame: Assessed at exit interview
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