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Lookup NU author(s): Professor Steve RobsonORCiD, Catherine McParlin, Helen MossopORCiD, Dr Mabel LieORCiD, Dr Cristina Fernandez-Garcia, Denise Howel, Dr Ruth Graham, Professor Laura Ternent, Dr Alison SteelORCiD, Nicola GoudieORCiD, Afnan Nadeem, Julia PhillipsonORCiD, Emerita Professor Elaine McCollORCiD
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 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.
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
Date deposited: 30/11/2023
ISSN (print): 1366-5278
ISSN (electronic): 2046-4924
Publisher: NIHR Journals Library
URL: https://doi.org/10.3310/HTA25630
DOI: 10.3310/HTA25630
Data Access Statement: Anonymised data from this trial may be available to the scientific community subject to regulatory and ethics approval. Requests for data should be directed to the corresponding author.
PubMed id: 34782054
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