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

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... Mehr ...

Verfasser: van Gils, Lissa
de Boer, Marjon A
Bosmans, Judith
Duijnhoven, Ruben
Schoenmakers, Sam
Derks, Jan B
Prins, Jelmer R
Al-Nasiry, Salwan
Lutke Holzik, Margo
Lopriore, Enrico
van Drongelen, Joris
Knol, Marieke H
van Laar, Judith O E H
Jacquemyn, Yves
van Holsbeke, Caroline
Dehaene, Isabelle
Lewi, Liesbeth
van der Merwe, Hannes
Gyselaers, Wilfried
Obermann-Borst, Sylvia A
Holthuis, Mayella
Mol, Ben W
Pajkrt, Eva
Oudijk, Martijn A
Dokumenttyp: Artikel
Erscheinungsdatum: 2024
Reihe/Periodikum: van Gils , L , de Boer , M A , Bosmans , J , Duijnhoven , R , Schoenmakers , S , Derks , J B , Prins , J R , Al-Nasiry , S , Lutke Holzik , M , Lopriore , E , van Drongelen , J , Knol , M H , van Laar , J O E H , Jacquemyn , Y , van Holsbeke , C , Dehaene , I , Lewi , L , van der Merwe , H , Gyselaers , W , Obermann-Borst , S A , Holthuis , M , Mol , B W , Pajkrt , E & Oudijk , M A 2024 , ' 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 , no. 5 , e081561 , pp. 081561 . https://doi.org/10.1136/bmjopen-2023-081561
Schlagwörter: fetal medicine / maternal medicine / obstetrics / Humans / Female / Pregnancy / Cerclage / Cervical/methods / Twin / Premature Birth/prevention & control / Randomized Controlled Trials as Topic / Perinatal Mortality / Netherlands / Infant / Newborn / Multicenter Studies as Topic / Cervix Uteri/surgery / Adult
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-29187838
Datenquelle: BASE; Originalkatalog
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Link(s) : https://cris.maastrichtuniversity.nl/en/publications/e41e5b63-7131-46ad-8e50-ff3e2922b10d

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.