Early vaginal progesterone for the prevention of spontaneous preterm birth in twins: A randomised, placebo controlled, double-blinded trial – ‘EVENTS’
This is a multicentre trial in Spain, Belgium, Bulgaria, France, Italy and the UK. In all the participating centres, all eligible women with dichorionic diamniotic (DCDA) or monochorionic diamniotic (MCDA) twin pregnancy attending for their routine first hospital visit in pregnancy at 11-13 weeks’ gestation will be invited to participate in this randomized trial. The aim of the trial is to examine if the prophylactic use of vaginal Utrogestan from the first-trimester of pregnancy in women with twin pregnancy can reduce the incidence of spontaneous delivery before 34 weeks.
It is assumed that progesterone will reduce the incidence of spontaneous delivery between 24+0 and 33+6 weeks’ gestation by 40% from an anticipated 13% in the placebo group to 7.8% in the treatment group. A total sample of 1,080 participants has 80% power of detecting this difference at a (two-tailed) significance level of 5%.
Randomised controlled trial with pravastatin versus placebo for prevention of preeclampsia (STATIN trial)
This is a double-blind randomised placebo-controlled trial for which the eligible participants will be identified by a screening study. In the participating centres, in Spain, Italy, Belgium, Romania and the UK, all women attending for their routine hospital visit in pregnancy at 35+0-36+6 weeks’ gestation will be screened to identify a high-risk group for development of preeclampsia (PE). In this visit we will record maternal characteristics and medical history, measure the maternal MAP and serum PLGF and sFLT-1 and on the basis of these results estimate the risk for PE. Women that are screened positive for PE will be invited to participate in the randomised trial of pravastatin. The aim of the trial is to examine if the prophylactic use of pravastatin from 35-37 weeks’ gestation in women at increased risk for PE can reduce the incidence and severity of the disease.
The trial is powered for a 50% reduction in incidence of term-PE from 12% in the placebo group to 6% in the pravastatin group. For a power of 90%, using a two sided test at the 5% level of significance, it is necessary to randomise 1,020 high-risk pregnancies.