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