title: Early nasogastric tube feeding in optimising treatment for hyperemesis gravidarum: the MOTHER randomised controlled trial (Maternal and Offspring outcomes after Treatment of HyperEmesis by Refeeding).
abstract: BACKGROUND
  Hyperemesis gravidarum (HG), or intractable vomiting during pregnancy, is the single most frequent cause of hospital admission in early pregnancy. HG has a major impact on maternal quality of life and has repeatedly been associated with poor pregnancy outcome such as low birth weight. Currently, women with HG are admitted to hospital for intravenous fluid replacement, without receiving specific nutritional attention. Nasogastric tube feeding is sometimes used as last resort treatment. At present no randomised trials on dietary or rehydration interventions have been performed. Small observational studies indicate that enteral tube feeding may have the ability to effectively treat dehydration and malnutrition and alleviate nausea and vomiting symptoms. We aim to evaluate the effectiveness of early enteral tube feeding in addition to standard care on nausea and vomiting symptoms and pregnancy outcomes in HG patients.
  
  
  METHODS
  The MOTHER trial is a multicentre open label randomised controlled trial ( www.studies-obsgyn.nl/mother ). Women ≥ 18 years hospitalised for HG between 5 + 0 and 19 + 6 weeks gestation are eligible for participation. After informed consent participants are randomly allocated to standard care with intravenous rehydration or early enteral tube feeding in addition to standard care. All women keep a weekly diary to record symptoms and dietary intake until 20 weeks gestation. The primary outcome will be neonatal birth weight. Secondary outcomes will be the 24-h Pregnancy Unique Quantification of Emesis and nausea score (PUQE-24), maternal weight gain, dietary intake, duration of hospital stay, number of readmissions, quality of life and side-effects. Also gestational age at birth, placental weight, umbilical cord plasma lipid concentration and neonatal morbidity will be evaluated. Analysis will be according to the intention to treat principle.
  
  
  CONCLUSIONS
  With this trial we aim to clarify whether early enteral tube feeding is more effective in treating HG than intravenous rehydration alone and improves pregnancy outcome.
  
  
  BACKGROUND
  
  
  
  BACKGROUND
  NTR4197 . Date of registration: October 2(nd) 2013.
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. i.j.grooten@amc.uva.nl.|Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands. i.j.grooten@amc.uva.nl.
authors.forename: Iris J
authors.initials: IJ
authors.lastname: Grooten
authors.affiliation: The Robinson Institute, School of Paediatrics and Reproductive Health, University of Adelaide, Adelaide, Australia.
authors.forename: Ben W
authors.initials: BW
authors.lastname: Mol
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Joris A M
authors.initials: JAM
authors.lastname: van der Post
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.|Laboratory of Reproductive Biology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Carrie
authors.initials: C
authors.lastname: Ris-Stalpers
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Marjolein
authors.initials: M
authors.lastname: Kok
authors.affiliation: Department of Obstetrics and Gynaecology, Medical Centre Alkmaar, Alkmaar, The Netherlands.
authors.forename: Joke M J
authors.initials: JMJ
authors.lastname: Bais
authors.affiliation: Department of Obstetrics and Gynaecology, VU Medical Centre, VU University Amsterdam, Amsterdam, The Netherlands.
authors.forename: Caroline J
authors.initials: CJ
authors.lastname: Bax
authors.affiliation: Department of Obstetrics and Gynaecology, Erasmus MC, Erasmus Medical Centre Rotterdam, Rotterdam, The Netherlands.
authors.forename: Johannes J
authors.initials: JJ
authors.lastname: Duvekot
authors.affiliation: Department of Obstetrics and Gynaecology, Reinier de Graaf Hospital, Delft, The Netherlands.
authors.forename: Henk A
authors.initials: HA
authors.lastname: Bremer
authors.affiliation: Department of Obstetrics and Gynaecology, Máxima Medical Centre, Veldhoven, The Netherlands.
authors.forename: Martina M
authors.initials: MM
authors.lastname: Porath
authors.affiliation: Department of Obstetrics and Gynaecology, Radboud University Medical Centre, Nijmegen, The Netherlands.
authors.forename: Wieteke M
authors.initials: WM
authors.lastname: Heidema
authors.affiliation: Department of Obstetrics and Gynaecology, Leiden University Medical Centre, Leiden, The Netherlands.
authors.forename: Kitty W M
authors.initials: KWM
authors.lastname: Bloemenkamp
authors.affiliation: Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, The Netherlands.
authors.forename: Hubertina C J
authors.initials: HCJ
authors.lastname: Scheepers
authors.affiliation: Department of Obstetrics and Gynaecology, University Medical Centre Groningen, Groningen, The Netherlands.
authors.forename: Maureen T M
authors.initials: MTM
authors.lastname: Franssen
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Martijn A
authors.initials: MA
authors.lastname: Oudijk
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.|Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Tessa J
authors.initials: TJ
authors.lastname: Roseboom
authors.affiliation: Department of Obstetrics and Gynaecology, Academic Medical Centre, University of Amsterdam, Amsterdam, The Netherlands.
authors.forename: Rebecca C
authors.initials: RC
authors.lastname: Painter
mesh_terms: D000328:Adult; D001724:Birth Weight; D002985:Clinical Protocols; D004435:Eating; D004750:Enteral Nutrition / Q000379:methods*; D005260:Female; D005440:Fluid Therapy / Q000379:methods; D005865:Gestational Age; D006801:Humans; D006939:Hyperemesis Gravidarum / Q000473:pathology / Q000628:therapy*; D007231:Infant, Newborn; D007441:Intubation, Gastrointestinal; D007902:Length of Stay; D009325:Nausea / Q000209:etiology; D010359:Patient Readmission; D011247:Pregnancy; D011256:Pregnancy Outcome; D011788:Quality of Life; D012720:Severity of Illness Index; D016896:Treatment Outcome; D015430:Weight Gain; D055815:Young Adult
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