PC-study

Preterm birth (PTB) is in quantity and in severity the most important pregnancy complication in

obstetric care in the developed world. A cervical pessary and a cervical cerclage are both considered

as potential preventive treatments for spontaneous PTB in women at increase risk due to a history

of preterm birth or a short cervical length. This study evaluates the hypothesis that a cervical pessary

is non-inferior to a cervical cerclage in women who are scheduled for cerclage based on their risk

profile for spontaneous PTB.

The study is a nationwide open-label multicenter randomized clinical trial. Eligible women will be

randomized <24weeks in case of previous preterm delivery and short cervical

length to either a cervical pessary or cervical cerclage or before 16 weeks in case a primary cerclage

is required. Both cervical pessary and cervical cerclage will be removed at 36 weeks of GA or until

delivery, whatever comes first.

The primary outcome will be delivery before 32 weeks (<32 weeks). Secondary outcomes will

be preterm rate birth before 24, 28, 34 and 37 weeks, time from intervention to delivery, (early)

premature rupture of membranes, maternal infection, maternal side effects and composite bad

neonatal outcome including both morbidity and mortality rate of children as well as costs.

NA

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, 6 months (additional pregnancy) 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

Cerclage