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
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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 |