Pessary or Progesterone to Prevent Preterm delivery in women with short cervical length: the Quadruple P randomised controlled trial

BMC Pregnancy and Childbirth

Study Protocol

Brenda M. Kazemier¹  Maud D. van Zijl¹  Eva Pajkrt¹  Martijn A. Oudijk¹  Bouchra Koullali¹  Christiana A. Naaktgeboren²  Dimitri N. Papatsonis³  Erik van Beek⁴  Nico W. Schuitemaker⁵  Wilhelmina M. van Baal⁶  Anjoke J. M. Huisjes⁷  Marieke Sueters⁸  Hubertina C. J. Scheepers⁹  Evelyn C. J. Verheijen^1,10  Jozien T. J. Brons^1,11  Dick J. Bekedam^1,12  Etelka Moll^1,13  Joris van Drongelen^1,14  Karin de Boer^1,15  Flip W. van de Made^1,16  Eveline M. Tepe^1,17  Karlijn C. Vollebregt^1,18  Moira A. Muller^1,19  Henricus Visser^2,20  Maureen T. Franssen^2,21  Mireille N. Bekker^2,22  Marjon A. de Boer^2,23  Angelo B. Hooker^2,24  Josje Langenveld^2,25  Ewoud Schuit^2,26  Ben Willem J. Mol^2,27 

[1] Department of Obstetrics and Gynaecology, Academic Medical Center (AMC), Meibergdreef 9, 1105, Amsterdam, AZ, The Netherlands;Department of Obstetrics and Gynaecology, Academic Medical Center (AMC), Meibergdreef 9, 1105, Amsterdam, AZ, The Netherlands;Julius Centre for General Practice and Health Sciences, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands;Department of Obstetrics and Gynaecology, Amphia Hospital, Breda, The Netherlands;Department of Obstetrics and Gynaecology, Antonius Hospital, Nieuwegein, The Netherlands;Department of Obstetrics and Gynaecology, Diakonessenhuis, Utrecht, The Netherlands;Department of Obstetrics and Gynaecology, Flevoziekenhuis, Almere, The Netherlands;Department of Obstetrics and Gynaecology, Gelre Hospital, Apeldoorn, The Netherlands;Department of Obstetrics and Gynaecology, Leiden University Medical Centre (LUMC), Leiden, The Netherlands;Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC), Maastricht, The Netherlands;Department of Obstetrics and Gynaecology, Maasziekenhuis Pantein, Boxmeer, The Netherlands;Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, The Netherlands;Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis (OLVG) Oost, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis (OLVG) West, Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, The Netherlands;Department of Obstetrics and Gynaecology, Rijnstate Hospital, Arnhem, The Netherlands;Department of Obstetrics and Gynaecology, Sint Franciscus Gasthuis, Rotterdam, The Netherlands;Department of Obstetrics and Gynaecology, Slingeland Hospital, Doetinchem, The Netherlands;Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, The Netherlands;Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Hoofddorp, The Netherlands;Department of Obstetrics and Gynaecology, Tergooi Hospital, Hilversum, The Netherlands;Department of Obstetrics and Gynaecology, University Medical Centre Groningen (UMCG), Groningen, The Netherlands;Department of Obstetrics and Gynaecology, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands;Department of Obstetrics and Gynaecology, VU Medical Centre (VUmc), Amsterdam, The Netherlands;Department of Obstetrics and Gynaecology, Zaans Medical Centre (ZMC), Zaandam, The Netherlands;Department of Obstetrics and Gynaecology, Zuyderland Hospital, Heerlen, The Netherlands;Julius Centre for General Practice and Health Sciences, University Medical Centre Utrecht (UMCU), Utrecht, The Netherlands;Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia;

关键词: Preterm birth;    Singletons;    Multiples;    Prevention;    Pessary;    Progesterone;   

DOI  :  10.1186/s12884-017-1454-x

 received in 2017-06-07, accepted in 2017-08-15,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundPreterm birth is in quantity and in severity the most important topic in obstetric care in the developed world. Progestogens and cervical pessaries have been studied as potential preventive treatments with conflicting results. So far, no study has compared both treatments.Methods/designThe Quadruple P study aims to compare the efficacy of vaginal progesterone and cervical pessary in the prevention of adverse perinatal outcome associated with preterm birth in asymptomatic women with a short cervix, in singleton and multiple pregnancies separately. It is a nationwide open-label multicentre randomized clinical trial (RCT) with a superiority design and will be accompanied by an economic analysis. Pregnant women undergoing the routine anomaly scan will be offered cervical length measurement between 18 and 22 weeks in a singleton and at 16–22 weeks in a multiple pregnancy. Women with a short cervix, defined as less than, or equal to 35 mm in a singleton and less than 38 mm in a multiple pregnancy, will be invited to participate in the study.Eligible women will be randomly allocated to receive either progesterone or a cervical pessary. Following randomization, the silicone cervical pessary will be placed during vaginal examination or 200 mg progesterone capsules will be daily self-administered vaginally. Both interventions will be continued until 36 weeks gestation or until delivery, whichever comes first.Primary outcome will be composite adverse perinatal outcome of perinatal mortality and perinatal morbidity including bronchopulmonary dysplasia, intraventricular haemorrhage grade III and IV, periventricular leukomalacia higher than grade I, necrotizing enterocolitis higher than stage I, Retinopathy of prematurity (ROP) or culture proven sepsis. These outcomes will be measured up until 10 weeks after the expected due date. Secondary outcomes will be, among others, time to delivery, preterm birth rate before 28, 32, 34 and 37 weeks, admission to neonatal intensive care unit, maternal morbidity, maternal admission days for threatened preterm labour and costs.DiscussionThis trial will provide evidence on whether vaginal progesterone or a cervical pessary is more effective in decreasing adverse perinatal outcome in both singletons and multiples.Trial registrationTrial registration number: NTR 4414. Date of registration January 29th 2014.

【 授权许可】

CC BY   
© The Author(s). 2017