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. 2019 Jun 17;2019(6):CD002253. doi: 10.1002/14651858.CD002253.pub4

NCT02633761.

Trial name or title Mifepristone and misoprostol versus misoprostol alone for treatment of fetal death at 14‐28 weeks of pregnancy: a randomised, placebo‐controlled double‐blinded trial
Methods Allocation: randomised
Intervention model: parallel assignment
Masking: quadruple (participant, care provider, investigator, outcomes assessor)
Primary purpose: treatment
Participants Inclusion criteria
  1. Demised fetus of between 14 to 28 weeks duration confirmed by ultrasound

  2. Have no contraindications to study procedure, according to provider

  3. Be able to consent to procedure, either by reading consent document or by having consent document read to her

  4. Be willing to follow study procedures

Interventions Active comparator group 1: 200 mg mifepristone followed in 24 hours by repeated doses of 200 μg: buccal misoprostol given every 3 hours
Placebo comparator group 2: placebo followed in 24 hours by 200 μg: buccal misoprostol given every 3 hours.
Outcomes Complete uterine evacuation of the fetus and placenta without surgical intervention [time frame: 48 hours]
Complete uterine evacuation of fetus and placenta using study drug alone without recourse to any additional surgical intervention
Starting date April 2015
Contact information Hillary Bracken, PhD; hbracken@gynuity.org
Notes