Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum (VOMIT)
Hyperemesis Gravidarum, Nausea Gravidarum, Vomiting of Pregnancy
About this trial
This is an interventional treatment trial for Hyperemesis Gravidarum focused on measuring Hyperemesis Gravidarum (HG), Mirtazapine, Ondansetron, Pregnancy, Nausea and Vomiting of Pregnancy (NVP), Randomized Controlled Trial (RCT)
Eligibility Criteria
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
- weight loss >5% of pre-pregnancy weight and/or
- 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
Sites / Locations
- Department of Gynaecology and Obstetrics, Aarhus University Hospital
- Department of Gynaecology and Obstetrics, Rigshospitalet
- Department of Gynaecology and Obstetrics, Herlev Hospital
- Department of Gynaecology and Obstetrics, Nordsjællands Hospital
- Department of Gynaecology and Obstetrics, Hvidovre Hospital
- Department of Gynaecology and Obstetrics, Kolding Sygehus
- Department of Gynaecology and Obstetrics, Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Mirtazapine
Ondansetron
Placebo
Mirtazapine 15 mg oral tablet (incapsulated in gelatine to provide blinding) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered once daily (morning). On Day 7 dosage increase is optional. If desired, mirtazapine 30 mg oral tablet (incapsulated in gelatine) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered three times daily (morning, noon and late afternoon). In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.
Ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered twice daily (morning and bedtime) for 7 days. On Day 7 dosage increase is optional. If desired, ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.
Placebo oral tablet (empty gelatine capsule) will be administered twice daily (morning and bedtime) for 7 days. On Day 7 dosage increase is optional. If desired, placebo oral tablet (empty gelatine capsule) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.