title: Immediate delivery versus expectant monitoring for hypertensive disorders of pregnancy between 34 and 37 weeks of gestation (HYPITAT-II): an open-label, randomised controlled trial.
abstract: BACKGROUND
  There is little evidence to guide the management of women with hypertensive disorders in late preterm pregnancy. We investigated the effect of immediate delivery versus expectant monitoring on maternal and neonatal outcomes in such women.
  
  
  METHODS
  We did an open-label, randomised controlled trial, in seven academic hospitals and 44 non-academic hospitals in the Netherlands. Women with non-severe hypertensive disorders of pregnancy between 34 and 37 weeks of gestation were randomly allocated to either induction of labour or caesarean section within 24 h (immediate delivery) or a strategy aimed at prolonging pregnancy until 37 weeks of gestation (expectant monitoring). The primary outcomes were a composite of adverse maternal outcomes (thromboembolic disease, pulmonary oedema, eclampsia, HELLP syndrome, placental abruption, or maternal death), and neonatal respiratory distress syndrome, both analysed by intention-to-treat. This study is registered with the Netherlands Trial Register (NTR1792).
  
  
  RESULTS
  Between March 1, 2009, and Feb 21, 2013, 897 women were invited to participate, of whom 703 were enrolled and randomly assigned to immediate delivery (n=352) or expectant monitoring (n=351). The composite adverse maternal outcome occurred in four (1·1%) of 352 women allocated to immediate delivery versus 11 (3·1%) of 351 women allocated to expectant monitoring (relative risk [RR] 0·36, 95% CI 0·12-1·11; p=0·069). Respiratory distress syndrome was diagnosed in 20 (5·7%) of 352 neonates in the immediate delivery group versus six (1·7%) of 351 neonates in the expectant monitoring group (RR 3·3, 95% CI 1·4-8·2; p=0·005). No maternal or perinatal deaths occurred.
  
  
  CONCLUSIONS
  For women with non-severe hypertensive disorders at 34-37 weeks of gestation, immediate delivery might reduce the already small risk of adverse maternal outcomes. However, it significantly increases the risk of neonatal respiratory distress syndrome, therefore, routine immediate delivery does not seem justified and a strategy of expectant monitoring until the clinical situation deteriorates can be considered.
  
  
  BACKGROUND
  ZonMw.
authors: Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands. Electronic address: k.broekhuijsen@gmail.com.
authors: Kim
authors: K
authors: Broekhuijsen
authors: Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.
authors: Gert-Jan
authors: GJ
authors: van Baaren
authors: Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.
authors: Maria G
authors: MG
authors: van Pampus
authors: Department of Obstetrics and Gynaecology, Academic Medical Centre, Amsterdam, Netherlands.
authors: Wessel
authors: W
authors: Ganzevoort
authors: Department of Obstetrics and Gynaecology, ZGT Almelo, Almelo, Netherlands.
authors: J Marko
authors: JM
authors: Sikkema
authors: Department of Obstetrics and Gynaecology, Radboud University Medical Center, Nijmegen, Netherlands.
authors: Mallory D
authors: MD
authors: Woiski
authors: Department of Obstetrics, University Medical Center Utrecht, Utrecht, Netherlands.
authors: Martijn A
authors: MA
authors: Oudijk
authors: Department of Obstetrics, Leiden University Medical Center, Leiden, Netherlands.
authors: Kitty W M
authors: KW
authors: Bloemenkamp
authors: Department of Obstetrics and Gynaecology, Grow, School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, Netherlands.
authors: Hubertina C J
authors: HC
authors: Scheepers
authors: Department of Obstetrics and Gynaecology, Reinier de Graaf Gasthuis, Delft, Netherlands.
authors: Henk A
authors: HA
authors: Bremer
authors: Department of Obstetrics and Gynaecology, Jeroen Bosch Hospital, 's-Hertogenbosch, Netherlands.
authors: Robbert J P
authors: RJ
authors: Rijnders
authors: Department of Obstetrics and Gynaecology, Martini Hospital, Groningen, Netherlands.
authors: Aren J
authors: AJ
authors: van Loon
authors: Department of Obstetrics and Gynaecology, Medical Center Leeuwarden, Leeuwarden, Netherlands.
authors: Denise A M
authors: DA
authors: Perquin
authors: Department of Obstetrics and Gynaecology, Canisius-Wilhelmina Hospital, Nijmegen, Netherlands.
authors: Jan M J
authors: JM
authors: Sporken
authors: Department of Obstetrics and Gynaecology, Amphia Hospital Breda, Breda, Netherlands.
authors: Dimitri N M
authors: DN
authors: Papatsonis
authors: Department of Obstetrics and Gynaecology, HagaZiekenhuis, The Hague, Netherlands.
authors: Marloes E
authors: ME
authors: van Huizen
authors: Department of Obstetrics and Gynaecology, Medical Center Haaglanden, The Hague, Netherlands.
authors: Corla B
authors: CB
authors: Vredevoogd
authors: Department of Obstetrics and Gynaecology, Medisch Spectrum Twente, Enschede, Netherlands.
authors: Jozien T J
authors: JT
authors: Brons
authors: Department of Obstetrics and Gynaecology, Röpcke-Zweers Hospital, Hardenberg, Netherlands.
authors: Mesrure
authors: M
authors: Kaplan
authors: Department of Neonatology, Emma Children's Hospital, Academic Medical Centre, Amsterdam, Netherlands.
authors: Anton H
authors: AH
authors: van Kaam
authors: Department of Epidemiology-HPC FA40, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
authors: Henk
authors: H
authors: Groen
authors: Department of Obstetrics and Gynaecology, Maxima Medical Center, Veldhoven, Netherlands.
authors: Martina M
authors: MM
authors: Porath
authors: Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
authors: Paul P
authors: PP
authors: van den Berg
authors: The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, SA, Australia.
authors: Ben W J
authors: BW
authors: Mol
authors: Department of Obstetrics and Gynaecology, University of Groningen, University Medical Center Groningen, Groningen, Netherlands.
authors: Maureen T M
authors: MT
authors: Franssen
authors: Department of Obstetrics and Gynaecology, Atrium Medical Centre Parkstad, Heerlen, Netherlands.
authors: Josje
authors: J
authors: Langenveld
mesh_terms: D000328:Adult; D002585:Cesarean Section; D005260:Female; D006801:Humans; D006973:Hypertension / Q000175:diagnosis / Q000628:therapy*; D046110:Hypertension, Pregnancy-Induced / Q000175:diagnosis / Q000628:therapy*; D007231:Infant, Newborn; D007751:Labor, Induced; D008991:Monitoring, Physiologic; D011225:Pre-Eclampsia / Q000175:diagnosis / Q000628:therapy*; D011247:Pregnancy; D011249:Pregnancy Complications, Cardiovascular / Q000175:diagnosis / Q000628:therapy*; D011256:Pregnancy Outcome; D011263:Pregnancy Trimester, Third; D012307:Risk Factors