Cervical pessary to prevent preterm birth and poor neonatal outcome: An integrity meta-analysis of randomized controlled trials focusing on adherence to the European Medical Device Regulation.
Ioannis KyvernitakisAhmet A BaschatMarcel MalanWerner RathRichard BergerWolfgang HenrichEkkehard SchleussnerBahareh YousefiNina TimmesfeldHolger MaulPublished in: International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics (2023)
Non-audited RCTs and meta-analyses mixing studies of different clinical quality as pre-defined by a CEP and the MDR pose the risk for erroneous conclusions.