Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum

Validating the Effect of Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum: A Double-Blind Randomised Placebo-Controlled Multicentre Trial

The aim is to investigate the efficacy of mirtazapine and ondansetron as treatment for hyperemesis gravidarum(HG).

The setup is a double-blind multicenter trial where patients suffering from HG will be randomized to treatment with either mirtazapine, ondansetron or placebo (1:1:1).

Inclusion Criteria:

• Written informed consent obtained before any trial related procedures are performed

• Female age >18 years

• Pregnant woman with gestational age between 5+0 and 19+6

• Nausea and vomiting without other obvious reason

• PUQE-24 score ≥13 OR PUQE-24 score ≥7 AND

  1. weight loss >5% of pre-pregnancy weight and/or
  2. hospitalisation due to nausea and vomiting of pregnancy

• Singleton pregnancy

• The subject must be willing and able to comply with trial protocol

Exclusion Criteria:

• Mola pregnancy, multiple gestation or non-vital pregnancy
• Nausea and vomiting of other aetiology than NVP
• Allergic to selective 5-HT3-receptor antagonists
• Ongoing treatment with antidepressant medication
• Pre-existing diagnosis of chronic kidney disease, diabetes type 1 or 2, significant cardiac disease (incl. long QT syndrome), epilepsy, HIV. In case of other pre-existing conditions subjects might be excluded based on individual assessment by an MD
• Elevated liver enzymes (ALAT>150 U/l)
• Elevated creatinine (>100 µmol/l)
• ECG showing long QT-syndrome (QTc >460msek)
• Weekly alcohol intake >2 units of alcohol
• Not able to take medicine orally
• Not able to understand spoken and/or written Danish
• Participation in another investigational drug trial within current pregnancy