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 analysisThis 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 disseminationThe 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 numberNCT03785691
Summary
Since the thalidomide scandal in the 1960's use of drugs in pregnancy has often been associated with great uncertainty, it can affect both the mother and the fetus. However, the concern may mistakenly lead to nonharmful drugs being attributed teratogenic effects. The drug use during pregnancy and the safety of the most commonly used drugs are in the following being discussed. Furthermore, a practical guide to risk assessment and considerations when initiating a drug treatment is presented.
Since the thalidomide scandal in the 1960s use of drugs during pregnancy and lactation has often been associated with great uncertainty, since it can affect both the mother and the breastfed child. However, the concern may mistakenly lead to nonharmful drugs being attributed harmful adverse drug reactions leading to undertreatment of the mother of unnecessary discontinuation of breastfeeding. The safety of the most commonly used drugs in lactation is in the following being discussed. Furthermore, a practical guide to risk assessment and considerations when initiating a drug treatment is presented.
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