A multi-centre, non-inferiority, randomised controlled trial to compare a cervical pessary with a cervical cerclage in the prevention of preterm delivery in women with short cervical length and a history of preterm birth - PC study
- Koullali, Bouchra
- van Kempen, Liselotte E.M.
- van Zijl, Maud D.
- Naaktgeboren, Christiana A.
- Schuit, Ewoud
- Bekedam, Dick J.
- Franssen, Maureen T.M.
- Nij Bijvank, Sebastiaan W.A.
- Sueters, Marieke
- van Baal, Marchien
- de Boer, Marjon A.
- Hooker, Angelo B.
- Hermsen, Brenda B.J.
- Toolenaar, Toon A.A.M.
- Zwart, Joost J.
- van der Ham, David P.
- van der Made, Flip W.
- Prefumo, Federico
- Martinez de Tejada, Begoña
- Papatsonis, Dimitri N.M.
- Huisjes, Anjoke J.M.
- Scheepers, Liesbeth H.C.J.
- van Hoorn, Marion E.
- Hasaart, Tom H.M.
- Schuitemaker, Nico W.E.
- Vollebregt, Karlijn C.
- Müller, Moira A.
- Evers, Inge M.
- Post, Marinka S.
- de Boer, Karin
- Visser, Henricus
- Mensing van Charante, Nico A.
- Langenveld, Josje
- Steemers, Nicole Y.C.
- Mol, Ben W.J.
- Oudijk, Martijn A.
- Pajkrt, Eva
DOIAbstract
Background: Preterm birth is in quantity and in severity the most important contributor of perinatal morbidity and mortality both in well- and low-resource countries. Cervical pessary and cervical cerclage are both considered as preventive treatments in women at risk for preterm birth. We aim to evaluate whether a cervical pessary can replace cervical cerclage for preventing recurrent preterm birth in women with a prior preterm birth due to cervical insufficiency or in women with a prior preterm birth and a short cervix in the current pregnancy. Methods/design: A nationwide open-label multicentre randomised clinical trial will be set up to study women with a singleton pregnancy and a prior preterm birth before 34 weeks of gestation. Women a...
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