Status:
TERMINATED
Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum
Lead Sponsor:
Nordsjaellands Hospital
Collaborating Sponsors:
Bispebjerg Hospital
Aarhus University Hospital
Conditions:
Hyperemesis Gravidarum
Nausea Gravidarum
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2022
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03785691
Start Date
March 1 2019
End Date
July 31 2022
Last Update
January 30 2023
Active Locations (7)
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1
Department of Gynaecology and Obstetrics, Aarhus University Hospital
Aarhus, Denmark, 8200
2
Department of Gynaecology and Obstetrics, Rigshospitalet
Copenhagen, Denmark, 2100
3
Department of Gynaecology and Obstetrics, Herlev Hospital
Herlev, Denmark, 2730
4
Department of Gynaecology and Obstetrics, Nordsjællands Hospital
Hillerød, Denmark, 3400