The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP.
The primary aim of this trial is to compare the efficacy of mifepristone-misoprostol versus misoprostol alone for treatment of intrauterine fetal demise between 14 and 28 weeks LMP. This will be a randomized controlled double-blinded trial of 150 women comparing misoprostol alone to mifepristone plus misoprostol for evacuation of the uterus after fetal demise in the second and third trimester. All women in the trial will undergo routine screening and pre-medical induction care per standard practice at the hospital. All eligible women agreeing to participate in the study will be randomized to receive one of the following regimens: 1. STUDY GROUP ONE: 200mg mifepristone followed in 24 hours by repeated doses of 200mcg buccal misoprostol given every 3 hours; 2. STUDY GROUP TWO: placebo followed in 24 hours by 200mcg buccal misoprostol given every three hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
Buccal misoprostol 200mcg
Hospital General "Enrique Cabrera"
Mexico City, Mexico
National Institute of Perinatology (INPer)
Mexico City, Mexico
National Ob-Gyn Hospital
Hanoi, Vietnam
Complete uterine evacuation of the fetus and placenta without surgical intervention
Complete uterine evacuation of fetus and placenta using study drug alone without recourse to any additional surgical intervention
Time frame: 48 hours
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