NCT02145767.
Study name | Progesterone for the prevention of miscarriage and preterm birth in women with first trimester bleeding: PREEMPT Trial |
Methods | 2‐arm placebo‐controlled randomised trial. |
Participants | Women aged between 18 and 45 years with a live intrauterine singleton pregnancy of <14 weeks by crown‐rump length on ultrasound with documented fetal cardiac activity, and presence of a perigestational (subchorionic) haemorrhage on ultrasound. Exclusion criteria include contraindication to progesterone and any indication for progesterone. |
Interventions | Progesterone 200 mg suppository administered vaginally at bedtime until 34 completed weeks of pregnancy versus placebo |
Outcomes | Miscarriage (< 20 weeks); preterm birth (< 37 weeks); maternal outcomes; neonatal outcomes; healthcare outcomes |
Starting date | December 2014 |
Contact information | preempttrial@gmail.com |
Notes |