Quadruple P

Preterm birth is in quantity and in severity the most important issue in obstetric care in the developed world. Progestagens and cervical pessaries are both considered as potential preventive treatments. We aim to compare the effectiveness of vaginal progesterone and cervical pessary in the prevention of preterm birth in women with singleton and twin pregnancies with a short cervix. This study is a nationwide open-label multicenter randomized clinical trial with an economic analysis alongside it. Women with a singleton or twin pregnancy undergoing foetal assessment, at 18-22 weeks for singleton pregnancy and 16-22 weeks for multiple pregnancies, will be offered cervical length measurement. Women with a short cervix (singleton pregnancy 35 mm or less (11.5th percentile), multiple pregnancy less than 38 mm (25th percentile), will be invited to participate in a randomized clinical trial. Intervention are either daily progesterone 200mg which will be self-administered vaginally from time of randomization or the silicone cervical pessary which will be placed between 18-22 weeks for singletons or between 16-22 weeks for multiples. Both interventions will be applied until 36 weeks gestation or until delivery, whatever comes first. Primary outcome will be composite adverse neonatal outcome including both morbidity and mortality rate of children in the two groups. Secondary outcomes will be time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and cost.

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We will need a run-in period of 3 months for the study set up, and 36 months for inclusion. After inclusion of the last patient, 9 months (additional pregnancy + post-partum period) will be needed for data collection and report of results. The first report on the primary outcome is expected at 4 years after the start of the study.

Pessary vs. Progesterone