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Ondansetron and metoclopramide as second-line antiemetics in women with nausea and vomiting in pregnancy: The empower pilot FACTORIAL RCT

Lookup NU author(s): Professor Steve RobsonORCiD, Dr Catherine McParlin, Helen MossopORCiD, Dr Mabel LieORCiD, Dr Cristina Fernandez-Garcia, Denise Howel, Dr Ruth Graham, Dr Laura Ternent, Dr Alison SteelORCiD, Nicola GoudieORCiD, Afnan Nadeem, Julia PhillipsonORCiD, Professor Elaine McCollORCiD

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Abstract

© 2021 Robson et al.Background: Around one-third of pregnant women suffer from moderate to severe nausea and vomiting, causing physical and emotional distress and reducing their quality of life. There is no cure for nausea and vomiting in pregnancy. Management focuses on relieving symptoms and preventing morbidity, and often requires antiemetic therapy. National guidelines make recommendations about first-, second- and third-line antiemetic therapies, although care varies in different hospitals and women report feeling unsupported, dissatisfied and depressed. Objectives: To determine whether or not, in addition to intravenous rehydration, ondansetron compared with no ondansetron and metoclopramide compared with no metoclopramide reduced the rate of treatment failure up to 10 days after drug initiation; improved symptom severity at 2, 5 and 10 days after drug initiation; improved quality of life at 10 days after drug initiation; and had an acceptable side effect and safety profile. To estimate the incremental cost per treatment failure avoided and the net monetary benefits from the perspectives of the NHS and women. Design: This was a multicentre, double-dummy, randomised, double-blinded, dummy-controlled 2 × 2 factorial trial (with an internal pilot phase), with qualitative and health economic evaluations. Background: Around one-third of pregnant women suffer from moderate to severe nausea and vomiting, causing physical and emotional distress and reducing their quality of life. There is no cure for nausea and vomiting in pregnancy. Management focuses on relieving symptoms and preventing morbidity, and often requires antiemetic therapy. National guidelines make recommendations about first-, second- and third-line antiemetic therapies, although care varies in different hospitals and women report feeling unsupported, dissatisfied and depressed. Objectives: To determine whether or not, in addition to intravenous rehydration, ondansetron compared with no ondansetron and metoclopramide compared with no metoclopramide reduced the rate of treatment failure up to 10 days after drug initiation; improved symptom severity at 2, 5 and 10 days after drug initiation; improved quality of life at 10 days after drug initiation; and had an acceptable side effect and safety profile. To estimate the incremental cost per treatment failure avoided and the net monetary benefits from the perspectives of the NHS and women. Design: This was a multicentre, double-dummy, randomised, double-blinded, dummy-controlled 2 × 2 factorial trial (with an internal pilot phase), with qualitative and health economic evaluations.


Publication metadata

Author(s): Robson S, McParlin C, Mossop H, Lie M, Fernandez-Garcia C, Howel D, Graham R, Ternent L, Steel A, Goudie N, Nadeem A, Phillipson J, Shehmar M, Simpson N, Tuffnell D, Campbell I, Williams R, O'Hara ME, McColl E, Nelson-Piercy C

Publication type: Article

Publication status: Published

Journal: Health Technology Assessment

Year: 2021

Volume: 25

Issue: 63

Pages: VII-78

Print publication date: 01/11/2021

Online publication date: 01/11/2021

Acceptance date: 01/02/2021

ISSN (print): 1366-5278

ISSN (electronic): 2046-4924

Publisher: NIHR Journals Library

URL: https://doi.org/10.3310/HTA25630

DOI: 10.3310/HTA25630

PubMed id: 34782054


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