Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum
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 be randomized to treatment with either mirtazapine, ondansetron or placebo (1:1:1).
Timeline
- Start
- 2019-03-01
- Primary completion
- 2022-07-31
- Completion
- 2022-07-31
Outcome
Mixed primary results
Stopped (Enrollment): “Recruiting difficulties”
paper Difference in Pregnancy Unique Quantification of Emesis 24 score change from baseline to day 2 in the mirtazapine (n=21) vs the placebo (n=20) group was -1.86 (95% confidence interval, -3.61 to -0.12; P=.04). PMID 41478546 ↗
paper In ondansetron (n=18) vs placebo, the difference was -0.51 (95% confidence interval, -2.32 to 1.30) PMID 41478546 ↗
paper Ondansetron resulted in a smaller reduction in Pregnancy Unique Quantification of Emesis 24 score that did not reach statistical significance. PMID 41478546 ↗
Publications
- Ostenfeld A, Carlsen SE, Jensen AK, Futtrup TB, Westergaard HB, Pedersen LH, Andersen JT, Petersen TS, Lokkegaard ECL; VOMIT investigation group. Mirtazapine or ondansetron for hyperemesis gravidarum: a randomized placebo-controlled trial. Am J Obstet Gynecol. 2026 Jun;234(6):1700-1729. doi: 10.1016/j.ajog.2025.12.061. Epub 2025 Dec 30.
- Ostenfeld A, Petersen TS, Futtrup TB, Andersen JT, Jensen AK, Westergaard HB, Pedersen LH, Lokkegaard ECL. Validating the effect of Ondansetron and Mirtazapine In Treating hyperemesis gravidarum (VOMIT): protocol for a randomised placebo-controlled trial. BMJ Open. 2020 Mar 24;10(3):e034712. doi: 10.1136/bmjopen-2019-034712.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mirtazapine | Other / unclassified | 15 mg | Oral |
| Subject | Mirtazapine | Other / unclassified | 30 mg | Oral |
| Subject | Ondansetron | Other / unclassified | 8 mg | Oral |