EMPOWER

• Research type

  Research Study

• Full title

  EMPOWER: EMesis in Pregnancy - Ondansetron With mEtoclopRamide.

• IRAS ID

  227986

• Contact name

  Stephen Robson

• Contact email

  s.c.robson@ncl.ac.uk

• Sponsor organisation

  Newcastle upon Tyne Hospitals NHS Foundatation Trust

• Eudract number

  2017-001651-31

• Duration of Study in the UK

  2 years, 11 months, 31 days

• Research summary

  This trial will compare the effectiveness of two drugs (metoclopramide and ondansetron) for treating women with severe symptoms of nausea and vomiting in pregnancy (NVP) who have already tried using one anti-sickness drug but without improvement in their symptoms.

  Around 30% of women suffer from moderate to severe NVP, causing physical and emotional distress and reducing quality of life (QOL). The most severe form, hyperemesis gravidarum (HG), affects up to 3% of women, leading to dehydration, weight loss and nutrient deficiency.

  Moderate or severe NVP requires medical treatment, but care varies in different hospitals; women have reported feeling unsupported, dissatisfied, anxious and depressed.

  Women attending hospital with severe NVP, 16+6 weeks pregnant or less, who have had little or no improvement whilst taking initial (first line) anti-sickness treatment will be asked to participate in this trial.

  Participants will be randomly allocated to one of four treatment groups.

  Group 1: will receive metoclopramide with a placebo (dummy medication)
  Group 2: will receive ondansetron with a placebo
  Group 3: will receive metoclopramide and ondansetron
  Group 4: will receive a double placebo

  The drugs will initially be given into a vein three times a day for up to four days. Once women are able drink without vomiting, the same drugs will be given by tablet for up to ten days.

  Participants will be monitored and if at any point after 12 hours of treatment starting symptoms have not improved, the study drugs will be deemed to have failed and the medical staff will prescribe a third line antiemetic treatment.

  Patients approached to take part in EMPOWER will also be offered the opportunity to take part in an interview. Both women who take part and those that decline will be offered the opportunity to take part. These interviews are being carried out to help us understand the patient’s reason for participating or not participating in a complex trial of medication in pregnancy.

• REC name

  North East - Newcastle & North Tyneside 1 Research Ethics Committee

• REC reference

  17/NE/0325

• Date of REC Opinion

  30 Nov 2017

• REC opinion

  Further Information Favourable Opinion