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

BMC Pregnancy and Childbirth. 2017;17(1):1-9 DOI 10.1186/s12884-017-1393-6

 

Journal Homepage

Journal Title: BMC Pregnancy and Childbirth

ISSN: 1471-2393 (Online)

Publisher: BMC

LCC Subject Category: Medicine: Gynecology and obstetrics

Country of publisher: United Kingdom

Language of fulltext: English

Full-text formats available: PDF, HTML

 

AUTHORS

Bouchra Koullali (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))
Liselotte E.M. van Kempen (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))
Maud D. van Zijl (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))
Christiana A. Naaktgeboren (Julius Center for General Practice and Health Sciences, University Medical Center Utrecht (UMCU))
Ewoud Schuit (Julius Center for General Practice and Health Sciences, University Medical Center Utrecht (UMCU))
Dick J. Bekedam (Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis (OLVG) Oost)
Maureen T.M. Franssen (Department of Obstetrics and Gynaecology, University Medical Center Groningen (UMCG))
Sebastiaan W.A. Nij Bijvank (Department of Obstetrics and Gynaecology, Isala Hospital)
Marieke Sueters (Department of Obstetrics and Gynaecology, Leiden University Medical Center (LUMC))
Marchien van Baal (Department of Obstetrics and Gynaecology, Flevoziekenhuis)
Marjon A. de Boer (Department of Obstetrics and Gynaecology, VU Medical Center (VUmc))
Angelo B. Hooker (Department of Obstetrics and Gynaecology, Zaans Medical Center (ZMC))
Brenda B.J. Hermsen (Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis (OLVG) West)
Toon A.A.M. Toolenaar (Department of Obstetrics and Gynaecology, Albert Schweitzer Hospital)
Joost J. Zwart (Department of Obstetrics and Gynaecology, Deventer Hospital)
David P. van der Ham (Department of Obstetrics and Gynaecology, Martini Hospital)
Flip W. van der Made (Department of Obstetrics and Gynaecology, Sint Franciscus Gasthuis)
Federico Prefumo (Department of Obstetrics and Gynaecology, Spedali Civili di Brescia and University of Brescia)
Begoña Martinez de Tejada (Department of Obstetrics and Gynaecology, University Hospitals of Geneva and Faculty of Medicine)
Dimitri N.M. Papatsonis (Department of Obstetrics and Gynaecology, Amphia Hospital)
Anjoke J.M. Huisjes (Department of Obstetrics and Gynaecology, Gelre Hospital)
Liesbeth H.C.J. Scheepers (Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC))
Marion E. van Hoorn (Department of Obstetrics and Gynaecology, HagaZiekenhuis)
Tom H.M. Hasaart (Department of Obstetrics and Gynaecology, Catharina Hospital)
Nico W.E. Schuitemaker (Department of Obstetrics and Gynaecology, Diakonessenhuis)
Karlijn C. Vollebregt (Department of Obstetrics and Gynaecology, Spaarne Gasthuis)
Moira A. Müller (Department of Obstetrics and Gynaecology, Spaarne Gasthuis)
Inge M. Evers (Department of Obstetrics and Gynaecology, Meander Medical Center)
Marinka S. Post (Department of Obstetrics and Gynaecology, Medical Center Leeuwarden)
Karin de Boer (Department of Obstetrics and Gynaecology, Rijnstate Hospital)
Henricus Visser (Department of Obstetrics and Gynaecology, Tergooi Hospital)
Nico A. Mensing van Charante (Department of Obstetrics and Gynaecology, Westfries Gasthuis)
Josje Langenveld (Department of Obstetrics and Gynaecology, Zuyderland Hospital)
Nicole Y.C. Steemers (Department of Obstetrics and Gynaecology, Elizabeth TweeSteden Hospital)
Ben W.J. Mol (Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide)
Martijn A. Oudijk (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))
Eva Pajkrt (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))

EDITORIAL INFORMATION

Open peer review

Editorial Board

Instructions for authors

Time From Submission to Publication: 21 weeks

 

Abstract | Full Text

Abstract 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, <16 weeks) or in case of previous preterm birth and a short cervical length in current pregnancy ≤25 mm (secondary intervention, <24 weeks). Eligible women will be randomised to either cervical pessary or cervical cerclage. Both interventions will be removed at labour or at 36 weeks of gestational age, whatever comes first. The primary outcome will be delivery before 32 weeks. Secondary outcomes will be gestational age at birth, preterm birth rate before 24, 28, 34 and 37 weeks of gestation (overall and stratified by spontaneous or indicated delivery), premature rupture of membranes, use of tocolysis and/or corticosteroids during pregnancy, mode of delivery, maternal infections, maternal side effects, neonatal and maternal hospital admissions, and a composite of adverse perinatal outcomes including both morbidity and mortality. We assume an event rate of 20% preterm birth before 32 weeks for cerclage and use a non-inferiority margin of 10% for the cervical pessary. Using an alpha of 0.05 and power of 0.80 we need 2 groups of 200 women each. Discussion The outcome of this study will indicate the effectiveness and the cost-effectiveness of a cervical cerclage and of a cervical pessary. Trial registration Netherlands Trial Registry, NTR 4415 . Date registered: 29th of January 2014.