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

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 & 17 others 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

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageEnglish
Article number215
JournalBMC Pregnancy and Childbirth
Volume17
Issue number1
DOIs
Publication statusPublished - 6 Jul 2017

Cite this

Koullali, Bouchra ; van Kempen, Liselotte E.M. ; van Zijl, Maud D. ; Naaktgeboren, Christiana A. ; Schuit, Ewoud ; Bekedam, Dick J. ; Franssen, Maureen T.M. ; Nij Bijvank, Sebastiaan W.A. ; Sueters, Marieke ; van Baal, Marchien ; de Boer, Marjon A. ; Hooker, Angelo B. ; Hermsen, Brenda B.J. ; Toolenaar, Toon A.A.M. ; Zwart, Joost J. ; van der Ham, David P. ; van der Made, Flip W. ; Prefumo, Federico ; Martinez de Tejada, Begoña ; Papatsonis, Dimitri N.M. ; Huisjes, Anjoke J.M. ; Scheepers, Liesbeth H.C.J. ; van Hoorn, Marion E. ; Hasaart, Tom H.M. ; Schuitemaker, Nico W.E. ; Vollebregt, Karlijn C. ; Müller, Moira A. ; Evers, Inge M. ; Post, Marinka S. ; de Boer, Karin ; Visser, Henricus ; Mensing van Charante, Nico A. ; Langenveld, Josje ; Steemers, Nicole Y.C. ; Mol, Ben W.J. ; Oudijk, Martijn A. ; Pajkrt, Eva. / 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. In: BMC Pregnancy and Childbirth. 2017 ; Vol. 17, No. 1.
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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",
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.",
keywords = "Cerclage, Morbidity, Pessary, Preterm birth, Prevention",
author = "Bouchra Koullali and {van Kempen}, {Liselotte E.M.} and {van Zijl}, {Maud D.} and Naaktgeboren, {Christiana A.} and Ewoud Schuit and Bekedam, {Dick J.} and Franssen, {Maureen T.M.} and {Nij Bijvank}, {Sebastiaan W.A.} and Marieke Sueters and {van Baal}, Marchien and {de Boer}, {Marjon A.} and Hooker, {Angelo B.} and Hermsen, {Brenda B.J.} and Toolenaar, {Toon A.A.M.} and Zwart, {Joost J.} and {van der Ham}, {David P.} and {van der Made}, {Flip W.} and Federico Prefumo and {Martinez de Tejada}, Bego{\~n}a and Papatsonis, {Dimitri N.M.} and Huisjes, {Anjoke J.M.} and Scheepers, {Liesbeth H.C.J.} and {van Hoorn}, {Marion E.} and Hasaart, {Tom H.M.} and Schuitemaker, {Nico W.E.} and Vollebregt, {Karlijn C.} and M{\"u}ller, {Moira A.} and Evers, {Inge M.} and Post, {Marinka S.} and {de Boer}, Karin and Henricus Visser and {Mensing van Charante}, {Nico A.} and Josje Langenveld and Steemers, {Nicole Y.C.} and Mol, {Ben W.J.} and Oudijk, {Martijn A.} and Eva Pajkrt",
year = "2017",
month = "7",
day = "6",
doi = "10.1186/s12884-017-1393-6",
language = "English",
volume = "17",
journal = "BMC Pregnancy and Childbirth",
issn = "1471-2393",
publisher = "BioMed Central",
number = "1",

}

Koullali, B, van Kempen, LEM, van Zijl, MD, Naaktgeboren, CA, Schuit, E, Bekedam, DJ, Franssen, MTM, Nij Bijvank, SWA, Sueters, M, van Baal, M, de Boer, MA, Hooker, AB, Hermsen, BBJ, Toolenaar, TAAM, Zwart, JJ, van der Ham, DP, van der Made, FW, Prefumo, F, Martinez de Tejada, B, Papatsonis, DNM, Huisjes, AJM, Scheepers, LHCJ, van Hoorn, ME, Hasaart, THM, Schuitemaker, NWE, Vollebregt, KC, Müller, MA, Evers, IM, Post, MS, de Boer, K, Visser, H, Mensing van Charante, NA, Langenveld, J, Steemers, NYC, Mol, BWJ, Oudijk, MA & Pajkrt, E 2017, '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, vol. 17, no. 1, 215. https://doi.org/10.1186/s12884-017-1393-6

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

In: BMC Pregnancy and Childbirth, Vol. 17, No. 1, 215, 06.07.2017.

Research output: Contribution to journalArticleAcademicpeer-review

TY - JOUR

T1 - 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

AU - Koullali, Bouchra

AU - van Kempen, Liselotte E.M.

AU - van Zijl, Maud D.

AU - Naaktgeboren, Christiana A.

AU - Schuit, Ewoud

AU - Bekedam, Dick J.

AU - Franssen, Maureen T.M.

AU - Nij Bijvank, Sebastiaan W.A.

AU - Sueters, Marieke

AU - van Baal, Marchien

AU - de Boer, Marjon A.

AU - Hooker, Angelo B.

AU - Hermsen, Brenda B.J.

AU - Toolenaar, Toon A.A.M.

AU - Zwart, Joost J.

AU - van der Ham, David P.

AU - van der Made, Flip W.

AU - Prefumo, Federico

AU - Martinez de Tejada, Begoña

AU - Papatsonis, Dimitri N.M.

AU - Huisjes, Anjoke J.M.

AU - Scheepers, Liesbeth H.C.J.

AU - van Hoorn, Marion E.

AU - Hasaart, Tom H.M.

AU - Schuitemaker, Nico W.E.

AU - Vollebregt, Karlijn C.

AU - Müller, Moira A.

AU - Evers, Inge M.

AU - Post, Marinka S.

AU - de Boer, Karin

AU - Visser, Henricus

AU - Mensing van Charante, Nico A.

AU - Langenveld, Josje

AU - Steemers, Nicole Y.C.

AU - Mol, Ben W.J.

AU - Oudijk, Martijn A.

AU - Pajkrt, Eva

PY - 2017/7/6

Y1 - 2017/7/6

N2 - 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.

AB - 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.

KW - Cerclage

KW - Morbidity

KW - Pessary

KW - Preterm birth

KW - Prevention

UR - http://www.scopus.com/inward/record.url?scp=85021778206&partnerID=8YFLogxK

U2 - 10.1186/s12884-017-1393-6

DO - 10.1186/s12884-017-1393-6

M3 - Article

VL - 17

JO - BMC Pregnancy and Childbirth

JF - BMC Pregnancy and Childbirth

SN - 1471-2393

IS - 1

M1 - 215

ER -