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; Begona 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. Mueller; 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

doi: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

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, Begona Martinez de Tejada, Dimitri N. M. PapatsonisAnjoke 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. Mueller, 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

^*Corresponding author for this work

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

Discussion: The outcome of this study will indicate the effectiveness and the cost-effectiveness of a cervical cerclage and of a cervical pessary.

Original language	English
Article number	215
Number of pages	9
Journal	BMC Pregnancy and Childbirth
Volume	17
DOIs	https://doi.org/10.1186/s12884-017-1393-6
Publication status	Published - 6 Jul 2017

Keywords

Preterm birth
Prevention
Cerclage
Pessary
Morbidity
INCOMPETENCE
RECURRENCE
PREGNANCY
PECEP

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Cite this

Koullali, B., van Kempen, L. E. M., van Zijl, M. D., Naaktgeboren, C. A., Schuit, E., Bekedam, D. J., Franssen, M. T. M., Bijvank, S. W. A. N., Sueters, M., van Baal, M., de Boer, M. A., Hooker, A. B., Hermsen, B. B. J., Toolenaar, T. A. A. M., Zwart, J. J., van der Ham, D. P., van der Made, F. W., Prefumo, F., de Tejada, B. M., ... 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, 17, Article 215. https://doi.org/10.1186/s12884-017-1393-6

@article{1e38e0a3b3e94f9aa0ae672a33e9608e,

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,Discussion: The outcome of this study will indicate the effectiveness and the cost-effectiveness of a cervical cerclage and of a cervical pessary.",

keywords = "Preterm birth, Prevention, Cerclage, Pessary, Morbidity, INCOMPETENCE, RECURRENCE, PREGNANCY, PECEP",

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 Bijvank, {Sebastiaan W. A. Nij} 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 {de Tejada}, {Begona Martinez} 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 Mueller, {Moira A.} and Evers, {Inge M.} and Post, {Marinka S.} and {de Boer}, Karin and Henricus Visser and {van Charante}, {Nico A. Mensing} and Josje Langenveld and Steemers, {Nicole Y. C.} and Mol, {Ben W. J.} and Oudijk, {Martijn A.} and Eva Pajkrt",

year = "2017",

month = jul,

day = "6",

doi = "10.1186/s12884-017-1393-6",

language = "English",

volume = "17",

journal = "BMC Pregnancy and Childbirth",

issn = "1471-2393",

publisher = "BioMed Central Ltd",

}

Koullali, B, van Kempen, LEM, van Zijl, MD, Naaktgeboren, CA, Schuit, E, Bekedam, DJ, Franssen, MTM, Bijvank, SWAN, 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, de Tejada, BM, Papatsonis, DNM, Huisjes, AJM, Scheepers, LHCJ, van Hoorn, ME, Hasaart, THM, Schuitemaker, NWE, Vollebregt, KC, Mueller, MA, Evers, IM, Post, MS, de Boer, K, Visser, H, van Charante, NAM, 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, 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. et al.
In: BMC Pregnancy and Childbirth, Vol. 17, 215, 06.07.2017.

Research output: Contribution to journal › Article › Academic › peer-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 - Bijvank, Sebastiaan W. A. Nij

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 - de Tejada, Begona Martinez

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 - Mueller, Moira A.

AU - Evers, Inge M.

AU - Post, Marinka S.

AU - de Boer, Karin

AU - Visser, Henricus

AU - van Charante, Nico A. Mensing

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,Discussion: The outcome of this study will indicate the effectiveness and the cost-effectiveness of a cervical cerclage and of a cervical pessary.

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,Discussion: The outcome of this study will indicate the effectiveness and the cost-effectiveness of a cervical cerclage and of a cervical pessary.

KW - Preterm birth

KW - Prevention

KW - Cerclage

KW - Pessary

KW - Morbidity

KW - INCOMPETENCE

KW - RECURRENCE

KW - PREGNANCY

KW - PECEP

U2 - 10.1186/s12884-017-1393-6

DO - 10.1186/s12884-017-1393-6

M3 - Article

C2 - 28683739

SN - 1471-2393

VL - 17

JO - BMC Pregnancy and Childbirth

JF - BMC Pregnancy and Childbirth

M1 - 215

ER -

Koullali B, van Kempen LEM, van Zijl MD, Naaktgeboren CA, Schuit E, Bekedam DJ et al. 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. 2017 Jul 6;17:215. doi: 10.1186/s12884-017-1393-6