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

Lissa Van Gils; Marjon A. De Boer; Judith Bosmans; Ruben Duijnhoven; Sam Schoenmakers; Jan B. Derks; Jelmer R. Prins; Salwan Al-Nasiry; Margo Lutke Holzik; Enrico Lopriore; Joris Van Drongelen; Marieke H. Knol; Judith O.E.H. Van Laar; Yves Jacquemyn; Caroline Van Holsbeke; Isabelle Dehaene; Liesbeth Lewi; Hannes Van Der Merwe; Wilfried Gyselaers; Sylvia A. Obermann-Borst; Mayella Holthuis; Ben W. Mol; Eva Pajkrt; Martijn A. Oudijk

doi:10.1136/bmjopen-2023-081561

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

Lissa Van Gils^*
, Marjon A. De Boer
, Judith Bosmans
, Ruben Duijnhoven
, Sam Schoenmakers
, Jan B. Derks
, Jelmer R. Prins
, Salwan Al-Nasiry
, Margo Lutke Holzik
, Enrico Lopriore
, Joris Van Drongelen
, Marieke H. Knol
, Judith O.E.H. Van Laar
, Yves Jacquemyn
, Caroline Van Holsbeke
, Isabelle Dehaene
, Liesbeth Lewi
, Hannes Van Der Merwe
, Wilfried Gyselaers
, Sylvia A. Obermann-Borst

Mayella Holthuis, Ben W. Mol, Eva Pajkrt, Martijn A. Oudijk

^*Corresponding author for this work

Obstetrics & Gynecology

Amsterdam UMC
Utrecht University
University Medical Centre Groningen
Maastricht University
Leiden University
Radboud University Nijmegen
Isala Clinics
Maxima Medical Centre
Antwerp University Hospital
AZ Sint-Lucas (Bruges)
Ghent University Hospital
University Hospitals Leuven
East Limburg Hospital
Patient organization 'Extreme Vroeggeboorte'
Monash University

Research output: Contribution to journal › Article › Academic › peer-review

3 Citations (Scopus)

29 Downloads (Pure)

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.

Original language	English
Article number	e081561
Journal	BMJ open
Volume	14
Issue number	5
Early online date	10 May 2024
DOIs	https://doi.org/10.1136/bmjopen-2023-081561
Publication status	Published - May 2024

Bibliographical note

Publisher Copyright:
© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Access to Document

10.1136/bmjopen-2023-081561Licence: CC BY-NC

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 dilatationFinal published version, 400 KBLicence: CC BY-NC

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this

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., ... 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, 14(5), Article e081561. https://doi.org/10.1136/bmjopen-2023-081561

@article{81e495832f94491dbb1c5a1983a6bd63,

title = "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",

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.",

author = "\{Van Gils\}, Lissa and \{De Boer\}, \{Marjon A.\} and Judith Bosmans and Ruben Duijnhoven and Sam Schoenmakers and Derks, \{Jan B.\} and Prins, \{Jelmer R.\} and Salwan Al-Nasiry and \{Lutke Holzik\}, Margo and Enrico Lopriore and \{Van Drongelen\}, Joris and Knol, \{Marieke H.\} and \{Van Laar\}, \{Judith O.E.H.\} and Yves Jacquemyn and \{Van Holsbeke\}, Caroline and Isabelle Dehaene and Liesbeth Lewi and \{Van Der Merwe\}, Hannes and Wilfried Gyselaers and Obermann-Borst, \{Sylvia A.\} and Mayella Holthuis and Mol, \{Ben W.\} and Eva Pajkrt and Oudijk, \{Martijn A.\}",

note = "Publisher Copyright: {\textcopyright} Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.",

year = "2024",

month = may,

doi = "10.1136/bmjopen-2023-081561",

language = "English",

volume = "14",

journal = "BMJ open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "5",

}

Van Gils, L, De Boer, MA, Bosmans, J, Duijnhoven, R, Schoenmakers, S, Derks, JB, Prins, JR, Al-Nasiry, S, Lutke Holzik, M, Lopriore, E, Van Drongelen, J, Knol, MH, Van Laar, JOEH, Jacquemyn, Y, Van Holsbeke, C, Dehaene, I, Lewi, L, Van Der Merwe, H, Gyselaers, W, Obermann-Borst, SA, Holthuis, M, Mol, BW, Pajkrt, E & Oudijk, MA 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. https://doi.org/10.1136/bmjopen-2023-081561

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. / Van Gils, Lissa; De Boer, Marjon A.; Bosmans, Judith et al.
In: BMJ open, Vol. 14, No. 5, e081561, 05.2024.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - 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

T2 - The TWIN Cerclage studies

AU - Van Gils, Lissa

AU - De Boer, Marjon A.

AU - Bosmans, Judith

AU - Duijnhoven, Ruben

AU - Schoenmakers, Sam

AU - Derks, Jan B.

AU - Prins, Jelmer R.

AU - Al-Nasiry, Salwan

AU - Lutke Holzik, Margo

AU - Lopriore, Enrico

AU - Van Drongelen, Joris

AU - Knol, Marieke H.

AU - Van Laar, Judith O.E.H.

AU - Jacquemyn, Yves

AU - Van Holsbeke, Caroline

AU - Dehaene, Isabelle

AU - Lewi, Liesbeth

AU - Van Der Merwe, Hannes

AU - Gyselaers, Wilfried

AU - Obermann-Borst, Sylvia A.

AU - Holthuis, Mayella

AU - Mol, Ben W.

AU - Pajkrt, Eva

AU - Oudijk, Martijn A.

PY - 2024/5

Y1 - 2024/5

N2 - 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.

AB - 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.

UR - https://www.scopus.com/pages/publications/85192902538

U2 - 10.1136/bmjopen-2023-081561

DO - 10.1136/bmjopen-2023-081561

M3 - Article

C2 - 38729756

AN - SCOPUS:85192902538

SN - 2044-6055

VL - 14

JO - BMJ open

JF - BMJ open

IS - 5

M1 - e081561

ER -

Van Gils L, De Boer MA, Bosmans J, Duijnhoven R, Schoenmakers S, Derks JB et al. 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. 2024 May;14(5):e081561. Epub 2024 May 10. doi: 10.1136/bmjopen-2023-081561

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

Abstract

Bibliographical note

Access to Document

Other files and links

Fingerprint

Cite this