Newcastle Clinical Trials Unit



EMesis in Pregnancy - Ondansetron With mEtoclopRamide

  • Study stage: Closed
  • Sponsor: The Newcastle upon Tyne Hospitals NHS Foundation Trust
  • Funder: NIHR HTA
  • Therapeutic area: Reproductive Health and Childbirth
  • Type of study: CTIMP 

Aim: To determine whether, in addition to IV rehydration, ondansetron vs placebo ondansetron and metoclopramide vs placebo metoclopramide reduce the rate of treatment failure up to 10 days after initiation.

Primary outcome:

The number of participants requiring high dose ondansetron or corticosteroids between 12 hours and 10 days post first dose of IMP treatment

  • Population: Adult
  • Phase: III
  • Design: RCT(with internal pilot) Qualitative and Health Economics
  • Setting: Secondary Care
  • Planned Sample Size: 59