Quadruple-P follow-up

Vaginal progesterone and a cervical pessary are both interventions to prevent preterm birth in high risk pregnancies. Thus far, beneficial or harmful effects of these interventions on long-term child health and development are not described, but number of literature is scarce. With this follow-up study, we intent to investigate if progesterone or a pessary is superior for the prevention of preterm birth considering child’s health on the long term. This study is a follow-up study of the Quadruple-P trial; a multicentre, randomised clinical trial (NL42926.018.13, Eudractnumber 2013-002884-24) which randomises women with an asymptomatic midtrimester short cervix to daily progesterone or a pessary for the prevention of preterm birth. All children born to mothers who participated in the Quadruple-P study (n=628 singletons and n=332 multiples) will be eligible for follow-up at 4-6 years of corrected age. Children will be assessed using parental questionnaires. Primary outcomes are child (neuro)development and behavior. Secondary outcomes include child mortality, growth and general health. A composite of adverse child outcome will be compared between progesterone and pessary group reporting odds ratio and the corresponding 95% Confidence Interval. Analyses will be performed by intention to treat.

To assess the long-term effects of in utero exposure to progesterone or a pessary on child (neuro)development and behaviour at 6 years of corrected age

questionnaires will be filled in when children are 4 till 7 years of age