Investigation of the effect of ondansetron and mirtazapine as treatment for severe nausea and vomiting of pregnancy.

Phase 1

• Conditions: Hyperemesis gravidarum; MedDRA version: 20.0Level: PTClassification code 10020614Term: Hyperemesis gravidarumSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Body processes [G] - Reproductive physiologi cal processes [G08]

• Registration Number: EUCTR2018-002285-39-DK
• Lead Sponsor: Department of Gynaecology and Obstetrics Nordsjællands Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

•Pregnant 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 OR
2.hospitalisation due to nausea and vomiting of pregnancy
•Normal singleton pregnancy

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 180
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Mola-, multiple- or non-vital pregnancy
•Congenital long QT-syndrome
•Ongoing treatment with antidepressant medication
•Not able to take medicine orally
•Not able to understand spoken and written Danish

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified