ArticleBMJ open2020
Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum (VOMIT): protocol for a randomised placebo-controlled trial.
Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03785691 (Validating the Effect of Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Validating the Effect of Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum: A Double-Blind Randomised Placebo-Controlled Multicentre Trial
Who cites it
6 citing papers in PubMed, 12 citations in OpenAlex.
- Hyperemesis in Pregnancy: Complications and Treatment.Medical sciences (Basel, Switzerland) · 2025Review
- Understanding the effect of acupuncture on nausea and vomiting during pregnancy from a metabolic perspective: study protocol for a single-blinded randomized controlled trial.BMC complementary medicine and therapies · 2024Article
- Diagnosis and treatment of hyperemesis gravidarum.CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne · 2024Review
- Systematic evidence map of evidence addressing the top 10 priority research questions for hyperemesis gravidarum.BMJ open · 2022Article
- Mirtazapine exposure in pregnancy and fetal safety: A nationwide cohort study.Acta psychiatrica Scandinavica · 2022Article
- Anti-emetic effects of thalidomide: Evidence, mechanism of action, and future directions.Current research in pharmacology and drug discovery · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionCurrent pharmacological treatment options for hyperemesis gravidarum have been introduced based on scarce evidence and are often not sufficiently effective. Several case reports suggest that mirtazapine, an antidepressant, may be an effective treatment for hyperemesis gravidarum, but so far there are no controlled trials investigating the potential effect of mirtazapine on hyperemesis gravidarum. The antiemetic ondansetron is currently widely used to treat hyperemesis gravidarum despite sparse evidence of effect in pregnant women. This study aims to investigate the effect of mirtazapine on hyperemesis gravidarum while also providing data on the effect of ondansetron. METHODS AND ANALYSIS: This randomised double-blind placebo-controlled multicentre trial will be conducted in eight Danish hospitals. One hundred and eighty pregnant women referred to secondary care for hyperemesis gravidarum will be randomly allocated to 14-day treatment with either mirtazapine, ondansetron or placebo. Main inclusion criterion will be Pregnancy Unique Quantification of Emesis (PUQE-24) score ≥13 or PUQE-24 score ≥7 if accompanied by weight loss >5% of pre-pregnancy weight or hospitalisation. Participants are eligible regardless of whether other antiemetics, including ondansetron, have been tried. The coprimary outcomes are effects of mirtazapine and ondansetron, respectively, on PUQE-24 score tested hierarchically on day 2 and day 14. Secondary outcomes include, but are not limited to, differences between the three groups in number of daily vomiting episodes, dropout due to treatment failure, use of rescue medication, weight change and side effects. ETHICS AND DISSEMINATION: The trial has been approved by the Regional Committees on Health Research Ethics in the Capital Region of Denmark, the Danish Medicines Agency and the Danish Data Protection Agency. Results will be published in peer-reviewed journals and submitted to relevant conferences. TRIAL REGISTRATION NUMBER: NCT03785691.
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