Study protocol for two randomised controlled trials evaluating the effects of Cerclage in the reduction of extreme preterm birth and perinatal mortality in twin pregnancies with a short cervix or dilatation: the TWIN Cerclage studies
BMJ Open, vol. 14, pp. e081561
Abstract
INTRODUCTION: Twin pregnancies have a high risk of extreme preterm birth (PTB) at less than 28 weeks of gestation, which is associated with increased risk of neonatal morbidity and mortality. Currently there is a lack of effective treatments for women with a twin pregnancy and a short cervix or cervical dilatation. A possible effective surgical method to reduce extreme PTB in twin pregnancies with an asymptomatic short cervix or dilatation at midpregnancy is the placement of a vaginal cerclage. METHODS AND ANALYSIS: We designed two multicentre randomised trials involving eight hospitals in the Netherlands (sites in other countries may be added at a later date). Women older than 16 years with a twin pregnancy at <24 weeks of gestation and an asymptomatic short cervix of ≤25 mm or cervical dilatation will be randomly allocated (1:1) to both trials on vaginal cerclage and standard treatment according to the current Dutch Society of Obstetrics and Gynaecology guideline (no cerclage). Permuted blocks sized 2 and 4 will be used to minimise the risk of disbalance. The primary outcome measure is PTB of <28 weeks. Analyses will be by intention to treat. The first trial is to demonstrate a risk reduction from 25% to 10% in the short cervix group, for which 194 patients need to be recruited. The second trial is to demonstrate a risk reduction from 80% to 35% in the dilatation group and will recruit 44 women. A cost-effectiveness analysis will be performed from a societal perspective. ETHICS AND DISSEMINATION: This study has been approved by the Research Ethics Committees in the Netherlands on 3/30/2023. Participants will be required to sign an informed consent form. The results will be presented at conferences and published in a peer-reviewed journal. Participants will be informed about the results. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov, NCT05968794.
Authors 24
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Lissa van Gils corresponding
Amsterdam University Medical Centers
Affiliation as printed
Department of Obstetrics and Gynaecology, Amsterdam UMC, Amsterdam, The Netherlands
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Amsterdam University Medical Centers
Affiliation as printed
Department of Obstetrics and Gynaecology, Amsterdam UMC, Amsterdam, The Netherlands
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Amsterdam UMC Location University of Amsterdam · Amsterdam University Medical Centers
Affiliation as printed
Department of Health Sciences, Amsterdam UMC Location AMC, Amsterdam, Noord-Holland, The Netherlands
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Amsterdam University Medical Centers
Affiliation as printed
Department of Obstetrics and Gynaecology, Amsterdam UMC, Amsterdam, The Netherlands
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Affiliation as printed
Department of Obstetrics and Gynaecology, Erasmus Medical Center, Rotterdam, The Netherlands
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University Medical Center Utrecht
Affiliation as printed
Department of Obstetrics, University Medical Centre Utrecht, Utrecht, The Netherlands
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University Medical Center Groningen
Affiliation as printed
Department of Obstetrics and Gynaecology, University Medical Center Groningen, Groningen, The Netherlands
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Maastricht University Medical Centre
Affiliation as printed
Department of Obstetrics and Gynaecology, Maastricht UMC+, Maastricht, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Obstetrics and Gynecology, Leiden Universitair Medisch Centrum, Leiden, The Netherlands
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Leiden University Medical Center
Affiliation as printed
Department of Neonatology and Fetal Medicine, Leiden University Medical Center, Leiden, The Netherlands
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Affiliation as printed
Department of Obstetrics and Gynecology, Radboud Universiteit, Nijmegen, The Netherlands
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Affiliation as printed
Department of Obstetrics and Gynaecology, Isala Zwolle, Zwolle, The Netherlands
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Affiliation as printed
Department of Obstetrics & Gynaecology, Máxima Medical Center, Veldhoven, The Netherlands
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Affiliation as printed
University Hospital Antwerp, Antwerpen, Belgium
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Affiliation as printed
AZ Sint-Lucas Brugge, Brugge, West-Vlaanderen, Belgium
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Affiliation as printed
University Hospital Ghent, Gent, Belgium
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Universitair Ziekenhuis Leuven · KU Leuven
Affiliation as printed
Fetal Medicine Unit, KU Leuven University Hospitals Leuven, Leuven, Flanders, Belgium
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Universitair Ziekenhuis Leuven · KU Leuven
Affiliation as printed
Fetal Medicine Unit, KU Leuven University Hospitals Leuven, Leuven, Flanders, Belgium
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Affiliation as printed
Department of Obstetrics and Gynecology, Hospital Oost-Limburg, Genk, Belgium
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Affiliation as printed
Care4Neo, Neonatal patient and parent advocacy organization, Rotterdam, The Netherlands
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Affiliation as printed
Patient organization 'Extreme Vroeggeboorte', Amsterdam, The Netherlands
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Affiliation as printed
department of obstetrics and gynaecology, school of medicine, Monash University, Melbourne, Victoria, Australia
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Amsterdam University Medical Centers
Affiliation as printed
Department of Obstetrics and Gynaecology, Amsterdam UMC, Amsterdam, The Netherlands
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Amsterdam University Medical Centers
Affiliation as printed
Department of Obstetrics and Gynaecology, Amsterdam UMC, Amsterdam, The Netherlands
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