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

Bouchra Koullali*, Liselotte E. M. van Kempen, Maud D. van Zijl, Christiana A. Naaktgeboren, Ewoud Schuit, Dick J. Bekedam, Maureen T. M. Franssen, Sebastiaan W. A. Nij Bijvank, Marieke Sueters, Marchien van Baal, Marjon A. de Boer, Angelo B. Hooker, Brenda B. J. Hermsen, Toon A. A. M. Toolenaar, Joost J. Zwart, David P. van der Ham, Flip W. van der Made, Federico Prefumo, Begona Martinez de Tejada, Dimitri N. M. PapatsonisAnjoke J. M. Huisjes, Liesbeth H. C. J. Scheepers, Marion E. van Hoorn, Tom H. M. Hasaart, Nico W. E. Schuitemaker, Karlijn C. Vollebregt, Moira A. Mueller, Inge M. Evers, Marinka S. Post, Karin de Boer, Henricus Visser, Nico A. Mensing van Charante, Josje Langenveld, Nicole Y. C. Steemers, Ben W. J. Mol, Martijn A. Oudijk, Eva Pajkrt

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review


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 are eligible in case of previous preterm birth based on cervical insufficiency (primary intervention,

Discussion: The outcome of this study will indicate the effectiveness and the cost-effectiveness of a cervical cerclage and of a cervical pessary.

Original languageEnglish
Article number215
Number of pages9
JournalBMC Pregnancy and Childbirth
Publication statusPublished - 6 Jul 2017


  • Preterm birth
  • Prevention
  • Cerclage
  • Pessary
  • Morbidity

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