Pessaries in multiple pregnancy as a prevention of preterm birth: the ProTwin Trial

We aim to investigate the hypothesis that prophylactic use of a cervical pessary will be effective in the prevention of preterm delivery and the neonatal mortality and morbidity resulting from preterm delivery in multiple pregnancy. We will evaluate the costs and effects of this intervention. At study entry, cervical length will be measured. Eligible women will be randomly allocated to receive either a cervical pessary or no intervention. The cervical pessary will be placed in situ at 16 to 20 weeks, and will stay in situ up to 36 weeks gestation or until delivery, whatever comes first.The primary outcome is composite bad neonatal condition (perinatal death or severe morbidity). Secondary outcome measures are time to delivery, preterm birth rate before 32 and 37 weeks, days of admission in neonatal intensive care unit, maternal morbidity, maternal admission days for preterm labour and costs. We need to include 660 women to indicate a reduction in bad neonatal outcome from 7.2% without to 3.9% with a cervical pessary, using a two-sided test with an alpha of 0.05 and a power of 0.80.This trial will provide evidence on whether a cervical pessary will decrease the incidence of early preterm birth and its concomitant bad neonatal outcome in multiple pregnancies.Current Controlled Trials: NTR 1858Twin pregnancies are at high risk for preterm birth. In The Netherlands 15% of the women with a multiple pregnancy deliver before 34 weeks of gestation[1]. About 1 in 60 pregnancies is a twin pregnancy, and about 30% of the preterm born children admitted in a neonatal care (NICU) are from twin pregnancies. [2,3]. The incidence of twin pregnancies remains high due to an increase in the age of pregnant women. Prevention of preterm birth is therefore a major goal of obstetric care. However, strategies to prevent preterm birth have been largely unsuccessful.Bad neonatal outcome includes respiratory distress syndrome (RDS), bronchopulmonary dysplasia (BPD), intraventricular haemorrhag