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

BMC Pregnancy and Childbirth. 2017;17(1):1-8 DOI 10.1186/s12884-017-1454-x

 

Journal Homepage

Journal Title: BMC Pregnancy and Childbirth

ISSN: 1471-2393 (Online)

Publisher: BMC

LCC Subject Category: Medicine: Gynecology and obstetrics

Country of publisher: United Kingdom

Language of fulltext: English

Full-text formats available: PDF, HTML

 

AUTHORS

Maud D. van Zijl (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))
Bouchra Koullali (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))
Christiana A. Naaktgeboren (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))
Ewoud Schuit (Julius Centre for General Practice and Health Sciences, University Medical Centre Utrecht (UMCU))
Dick J. Bekedam (Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis (OLVG) Oost)
Etelka Moll (Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis (OLVG) West)
Martijn A. Oudijk (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))
Wilhelmina M. van Baal (Department of Obstetrics and Gynaecology, Flevoziekenhuis)
Marjon A. de Boer (Department of Obstetrics and Gynaecology, VU Medical Centre (VUmc))
Henricus Visser (Department of Obstetrics and Gynaecology, Tergooi Hospital)
Joris van Drongelen (Department of Obstetrics and Gynaecology, Radboud University Medical Center)
Flip W. van de Made (Department of Obstetrics and Gynaecology, Sint Franciscus Gasthuis)
Karlijn C. Vollebregt (Department of Obstetrics and Gynaecology, Spaarne Gasthuis)
Moira A. Muller (Department of Obstetrics and Gynaecology, Spaarne Gasthuis)
Mireille N. Bekker (Department of Obstetrics and Gynaecology, University Medical Centre Utrecht (UMCU))
Jozien T. J. Brons (Department of Obstetrics and Gynaecology, Medisch Spectrum Twente)
Marieke Sueters (Department of Obstetrics and Gynaecology, Leiden University Medical Centre (LUMC))
Josje Langenveld (Department of Obstetrics and Gynaecology, Zuyderland Hospital)
Maureen T. Franssen (Department of Obstetrics and Gynaecology, University Medical Centre Groningen (UMCG))
Nico W. Schuitemaker (Department of Obstetrics and Gynaecology, Diakonessenhuis)
Erik van Beek (Department of Obstetrics and Gynaecology, Antonius Hospital)
Hubertina C. J. Scheepers (Department of Obstetrics and Gynaecology, Maastricht University Medical Centre (MUMC))
Karin de Boer (Department of Obstetrics and Gynaecology, Rijnstate Hospital)
Eveline M. Tepe (Department of Obstetrics and Gynaecology, Slingeland Hospital)
Anjoke J. M. Huisjes (Department of Obstetrics and Gynaecology, Gelre Hospital)
Angelo B. Hooker (Department of Obstetrics and Gynaecology, Zaans Medical Centre (ZMC))
Evelyn C. J. Verheijen (Department of Obstetrics and Gynaecology, Maasziekenhuis Pantein)
Dimitri N. Papatsonis (Department of Obstetrics and Gynaecology, Amphia Hospital)
Ben Willem J. Mol (Robinson Research Institute, School of Paediatrics and Reproductive Health, University of Adelaide)
Brenda M. Kazemier (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))
Eva Pajkrt (Department of Obstetrics and Gynaecology, Academic Medical Center (AMC))

EDITORIAL INFORMATION

Open peer review

Editorial Board

Instructions for authors

Time From Submission to Publication: 21 weeks

 

Abstract | Full Text

Abstract Background Preterm 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/design The 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. Discussion This 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 registration Trial registration number: NTR 4414 . Date of registration January 29th 2014.