Prevention of preterm birth (PTB) is a key factor for a positive short-term and long-term outcome of the newborn children as mortality and morbidity are inversely related to gestational age at delivery. Consequently every week of prolonged pregnancy will have a tremendous effect concerning the outcome of the new-borns, subsequently for their parents and society as well. The proposed RCT aims to evaluate the impact of a preventive pessary treatment on the prevention of preterm birth in women with a singleton pregnancy who are at high risk of spontaneous preterm birth (sPTB) due to a history of at least one previous preterm delivery and/or a history of previous cervical surgery. In accordance with the results by "van´t Hooft et al. 2016" an approximately 20% higher percentage of children's long-term survival without neurodevelopmental disability is expected for the pessary group in comparison with usual management (=control group) on basis of a reduction of prematurity \< 34 week of gestation (WoG). The primary outcome measure for the effect of the pessary treatment in comparison to expectant management will be the children's long-term survival (3yrs) without neurodevelopmental disability. Secondary endpoints assess the impact of a preventive pessary placement on the prevention of preterm birth and its resulting risk on mortality and morbidity for the neonates.
Age range
18 Years – 45 Years
Sex
FEMALE
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Children's survival without neurodevelopmental disability at the age of 3 years
Timeframe: assessment of the newborn at age of 3 years (corrected age for prematurity)