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 \u2013 PC study

Bouchra Koullali,Flip W Van Der Made,Sebastiaan W.A Nij Bijvank,Henricus Visser,Marion E Van Hoorn,Angelo B Hooker,Christiana A Naaktgeboren,Marieke Sueters,Karlijn C Vollebregt,Maureen Franssen ,Karin Boer ,Toon Toolenaar ,Liesbeth Scheepers ,D.j Bekedam ,Nico A Mensing Van Charante ,M Van Baal ,T H M Hasaart ,Liselotte E M Van Kempen ,Ben Willem J Mol ,Begoña Martínez De Tejada ,Brenda Hermsen ,Anjoke Huisjes ,Nico Schuitemaker ,Dimitri Papatsonis ,M A Müller ,Josje Langenveld,Maud D Van Zijl,Ewoud Schuit,Nicole Y.C Steemers,Marinka S Post,Joost J Zwart,Marjon A De Boer,Federico Prefumo,Martijn A Oudijk,David P Van Der Ham,Inge M Evers,Eva Pajkrt

doi:10.1186/s12884-017-1393-6

Abstract

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, 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.

Highlights

Preterm birth is in quantity and in severity the most important contributor of perinatal morbidity and mortality both in well- and low-resource countries
We propose to compare the cervical pessary and cervical cerclage in a head-to-head comparison and hypothesise that the use of a cervical pessary will be effective in preventing preterm birth as cervical cerclage
To our knowledge there are no other registered on-going trials comparing the effect of a cervical pessary and a cervical cerclage in women at high risk for preterm birth

Summary

Introduction

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. Preterm birth is a major contributor to perinatal mortality. 50–70% is associated with preterm birth [1]. Preterm birth is the leading cause of neonatal morbidity, mostly due to respiratory immaturity, intracranial haemorrhages and infections. These conditions can result in long-term neurodevelopmental sequelae such as intellectual impairment, cerebral palsy, chronic lung disease, deafness and blindness [2]. Prevention of spontaneous preterm birth remains one of the biggest challenges in obstetric care

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