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
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 ai...
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BMC
2017-07-01
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| Series: | BMC Pregnancy and Childbirth |
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| Online Access: | http://link.springer.com/article/10.1186/s12884-017-1393-6 |
| _version_ | 1819264855077552128 |
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| author | Bouchra Koullali Liselotte E.M. van Kempen Maud D. van Zijl Christiana A. Naaktgeboren Ewoud Schuit Dick J. Bekedam Maureen T.M. Franssen Sebastiaan W.A. Nij Bijvank Marieke Sueters Marchien van Baal Marjon A. de Boer Angelo B. Hooker Brenda B.J. Hermsen Toon A.A.M. Toolenaar Joost J. Zwart David P. van der Ham Flip W. van der Made Federico Prefumo Begoña Martinez de Tejada Dimitri N.M. Papatsonis Anjoke J.M. Huisjes Liesbeth H.C.J. Scheepers Marion E. van Hoorn Tom H.M. Hasaart Nico W.E. Schuitemaker Karlijn C. Vollebregt Moira A. Müller Inge M. Evers Marinka S. Post Karin de Boer Henricus Visser Nico A. Mensing van Charante Josje Langenveld Nicole Y.C. Steemers Ben W.J. Mol Martijn A. Oudijk Eva Pajkrt |
| author_facet | Bouchra Koullali Liselotte E.M. van Kempen Maud D. van Zijl Christiana A. Naaktgeboren Ewoud Schuit Dick J. Bekedam Maureen T.M. Franssen Sebastiaan W.A. Nij Bijvank Marieke Sueters Marchien van Baal Marjon A. de Boer Angelo B. Hooker Brenda B.J. Hermsen Toon A.A.M. Toolenaar Joost J. Zwart David P. van der Ham Flip W. van der Made Federico Prefumo Begoña Martinez de Tejada Dimitri N.M. Papatsonis Anjoke J.M. Huisjes Liesbeth H.C.J. Scheepers Marion E. van Hoorn Tom H.M. Hasaart Nico W.E. Schuitemaker Karlijn C. Vollebregt Moira A. Müller Inge M. Evers Marinka S. Post Karin de Boer Henricus Visser Nico A. Mensing van Charante Josje Langenveld Nicole Y.C. Steemers Ben W.J. Mol Martijn A. Oudijk Eva Pajkrt |
| author_sort | Bouchra Koullali |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-23T20:36:07Z |
| format | Article |
| id | doaj.art-7db4923c8afb42f480d0e53a6e6ee295 |
| institution | Directory Open Access Journal |
| issn | 1471-2393 |
| language | English |
| last_indexed | 2024-12-23T20:36:07Z |
| publishDate | 2017-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pregnancy and Childbirth |
| spelling | doaj.art-7db4923c8afb42f480d0e53a6e6ee2952022-12-21T17:32:05ZengBMCBMC Pregnancy and Childbirth1471-23932017-07-011711910.1186/s12884-017-1393-6A 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 studyBouchra Koullali0Liselotte E.M. van Kempen1Maud D. van Zijl2Christiana A. Naaktgeboren3Ewoud Schuit4Dick J. Bekedam5Maureen T.M. Franssen6Sebastiaan W.A. Nij Bijvank7Marieke Sueters8Marchien van Baal9Marjon A. de Boer10Angelo B. Hooker11Brenda B.J. Hermsen12Toon A.A.M. Toolenaar13Joost J. Zwart14David P. van der Ham15Flip W. van der Made16Federico Prefumo17Begoña Martinez de Tejada18Dimitri N.M. Papatsonis19Anjoke J.M. Huisjes20Liesbeth H.C.J. Scheepers21Marion E. van Hoorn22Tom H.M. Hasaart23Nico W.E. Schuitemaker24Karlijn C. Vollebregt25Moira A. Müller26Inge M. Evers27Marinka S. Post28Karin de Boer29Henricus Visser30Nico A. Mensing van Charante31Josje Langenveld32Nicole Y.C. Steemers33Ben W.J. Mol34Martijn A. Oudijk35Eva Pajkrt36Department of Obstetrics and Gynaecology, Academic Medical Center (AMC)Department of Obstetrics and Gynaecology, Academic Medical Center (AMC)Department of Obstetrics and Gynaecology, Academic Medical Center (AMC)Julius Center for General Practice and Health Sciences, University Medical Center Utrecht (UMCU)Julius Center for General Practice and Health Sciences, University Medical Center Utrecht (UMCU)Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis (OLVG) OostDepartment of Obstetrics and Gynaecology, University Medical Center Groningen (UMCG)Department of Obstetrics and Gynaecology, Isala HospitalDepartment of Obstetrics and Gynaecology, Leiden University Medical Center (LUMC)Department of Obstetrics and Gynaecology, FlevoziekenhuisDepartment of Obstetrics and Gynaecology, VU Medical Center (VUmc)Department of Obstetrics and Gynaecology, Zaans Medical Center (ZMC)Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis (OLVG) WestDepartment of Obstetrics and Gynaecology, Albert Schweitzer HospitalDepartment of Obstetrics and Gynaecology, Deventer HospitalDepartment of Obstetrics and Gynaecology, Martini HospitalDepartment of Obstetrics and Gynaecology, Sint Franciscus GasthuisDepartment of Obstetrics and Gynaecology, Spedali Civili di Brescia and University of BresciaDepartment of Obstetrics and Gynaecology, University Hospitals of Geneva and Faculty of MedicineDepartment of Obstetrics and Gynaecology, Amphia HospitalDepartment of Obstetrics and Gynaecology, Gelre HospitalDepartment of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC)Department of Obstetrics and Gynaecology, HagaZiekenhuisDepartment of Obstetrics and Gynaecology, Catharina HospitalDepartment of Obstetrics and Gynaecology, DiakonessenhuisDepartment of Obstetrics and Gynaecology, Spaarne GasthuisDepartment of Obstetrics and Gynaecology, Spaarne GasthuisDepartment of Obstetrics and Gynaecology, Meander Medical CenterDepartment of Obstetrics and Gynaecology, Medical Center LeeuwardenDepartment of Obstetrics and Gynaecology, Rijnstate HospitalDepartment of Obstetrics and Gynaecology, Tergooi HospitalDepartment of Obstetrics and Gynaecology, Westfries GasthuisDepartment of Obstetrics and Gynaecology, Zuyderland HospitalDepartment of Obstetrics and Gynaecology, Elizabeth TweeSteden HospitalRobinson Research Institute, School of Paediatrics and Reproductive Health, University of AdelaideDepartment of Obstetrics and Gynaecology, Academic Medical Center (AMC)Department of Obstetrics and Gynaecology, Academic Medical Center (AMC)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.http://link.springer.com/article/10.1186/s12884-017-1393-6Preterm birthPreventionCerclagePessaryMorbidity |
| spellingShingle | Bouchra Koullali Liselotte E.M. van Kempen Maud D. van Zijl Christiana A. Naaktgeboren Ewoud Schuit Dick J. Bekedam Maureen T.M. Franssen Sebastiaan W.A. Nij Bijvank Marieke Sueters Marchien van Baal Marjon A. de Boer Angelo B. Hooker Brenda B.J. Hermsen Toon A.A.M. Toolenaar Joost J. Zwart David P. van der Ham Flip W. van der Made Federico Prefumo Begoña Martinez de Tejada Dimitri N.M. Papatsonis Anjoke J.M. Huisjes Liesbeth H.C.J. Scheepers Marion E. van Hoorn Tom H.M. Hasaart Nico W.E. Schuitemaker Karlijn C. Vollebregt Moira A. Müller Inge M. Evers Marinka S. Post Karin de Boer Henricus Visser Nico A. Mensing van Charante Josje Langenveld Nicole Y.C. Steemers Ben W.J. Mol Martijn A. Oudijk Eva Pajkrt 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 Preterm birth Prevention Cerclage Pessary Morbidity |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Preterm birth Prevention Cerclage Pessary Morbidity |
| url | http://link.springer.com/article/10.1186/s12884-017-1393-6 |
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multicentrenoninferiorityrandomisedcontrolledtrialtocompareacervicalpessarywithacervicalcerclageinthepreventionofpretermdeliveryinwomenwithshortcervicallengthandahistoryofpretermbirthpcstudy AT marinkaspost multicentrenoninferiorityrandomisedcontrolledtrialtocompareacervicalpessarywithacervicalcerclageinthepreventionofpretermdeliveryinwomenwithshortcervicallengthandahistoryofpretermbirthpcstudy AT karindeboer multicentrenoninferiorityrandomisedcontrolledtrialtocompareacervicalpessarywithacervicalcerclageinthepreventionofpretermdeliveryinwomenwithshortcervicallengthandahistoryofpretermbirthpcstudy AT henricusvisser multicentrenoninferiorityrandomisedcontrolledtrialtocompareacervicalpessarywithacervicalcerclageinthepreventionofpretermdeliveryinwomenwithshortcervicallengthandahistoryofpretermbirthpcstudy AT nicoamensingvancharante multicentrenoninferiorityrandomisedcontrolledtrialtocompareacervicalpessarywithacervicalcerclageinthepreventionofpretermdeliveryinwomenwithshortcervicallengthandahistoryofpretermbirthpcstudy AT josjelangenveld multicentrenoninferiorityrandomisedcontrolledtrialtocompareacervicalpessarywithacervicalcerclageinthepreventionofpretermdeliveryinwomenwithshortcervicallengthandahistoryofpretermbirthpcstudy AT nicoleycsteemers multicentrenoninferiorityrandomisedcontrolledtrialtocompareacervicalpessarywithacervicalcerclageinthepreventionofpretermdeliveryinwomenwithshortcervicallengthandahistoryofpretermbirthpcstudy AT benwjmol multicentrenoninferiorityrandomisedcontrolledtrialtocompareacervicalpessarywithacervicalcerclageinthepreventionofpretermdeliveryinwomenwithshortcervicallengthandahistoryofpretermbirthpcstudy AT martijnaoudijk multicentrenoninferiorityrandomisedcontrolledtrialtocompareacervicalpessarywithacervicalcerclageinthepreventionofpretermdeliveryinwomenwithshortcervicallengthandahistoryofpretermbirthpcstudy AT evapajkrt multicentrenoninferiorityrandomisedcontrolledtrialtocompareacervicalpessarywithacervicalcerclageinthepreventionofpretermdeliveryinwomenwithshortcervicallengthandahistoryofpretermbirthpcstudy |