Trial · NCT03785691
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 36
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group. | 2 days | Change in Pregnancy Unique Quantification of Emesis 24 score (PUQE-24 score) (patient reported) from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group. PUQE-24 score ranges 3-15 with 3 being better and 15 being worse. |
| Primary | Change in nausea and vomiting from baseline to Day 2 (short term) in the ondansetron group versus the placebo group. | 2 days | Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the ondansetron group versus the placebo group. |
| Primary | Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the mirtazapine group versus the placebo group. | 14 days | Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-) (long term) in the mirtazapine group versus the placebo group. Only tested if outcome 1 is significant. |
| Primary | Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the ondansetron group versus the placebo group. | 14 days | Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-) (long term) in the ondansetron group versus the placebo group. Only tested if outcome 2 is significant. |
| Primary | Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group. | 2 days | Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group. Only tested if outcome 1 is significant. |
| Secondary | Change in nausea and vomiting from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group. | 14 days | Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group. |
| Secondary | Overall nausea and vomiting during the intervention in the three different groups. | 14 days | Area under the curve for PUQE-24 score (patient reported) during the intervention in the three different groups. |
| Secondary | Change in well-being during the intervention in the three different groups. | 14 days | Change in PUQE well-being score (patient reported) during the intervention in the three different groups. |
| Secondary | Change in nausea during the intervention in the three different groups. | 14 days | Change in daily nausea visual analog scale (VAS) (patient reported) during the intervention in the three different groups. VAS score ranges 0-100 with 0 being better and 100 being worse. Numbers are not visible to subjects. |
| Secondary | Change in vomiting during the intervention in the three different groups. | 14 days | Change in number of daily vomiting episodes (patient reported) during the intervention in the three different groups. |
| Secondary | Occurrence of side effects in the three different groups. | 19 days | Occurrence of side effects (patient reported and registered by trial personnel) during and until 5 days after the intervention in the three different groups. |
| Secondary | Change in quality of life for nausea and vomiting during pregnancy from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. | 14 days | Change in Health-Related Quality of Life for Nausea and Vomiting during Pregnancy (NVPQOL) score (patient reported) from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. NVPQOL score ranges 30-210 with 30 being better and 210 being worse. |
| Secondary | Change in severity of hyperemesis gravidarum from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. | 14 days | Change in HyperEmesis Level Prediction (HELP) score (patient reported) from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. HELP score ranges 0-50 with 0 being better and 50 being worse. |
| Secondary | Change in health-related quality of life from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. | 14 days | Change in health status (EQ-5D-5L) (patient reported) from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. |
| Secondary | Change in sleep quality from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. | 14 days | Change in modified Pittsburg Sleep Quality Index (PSQI) (patient reported) from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.Modified PSQI score ranges 0-12 with 0 being better and 12 being worse. |
| Secondary | Patient satisfaction with treatment Day 7(+/-1) and Day 14(+/-1) in the three different groups. | 14 days | Patient satisfaction with treatment VAS (patient reported) on Day 7(+/-1) and Day 14(+/-1) in the three different groups. VAS score ranges 0-100 with 0 being better and 100 being worse. Numbers are not visible to subjects. |
| Secondary | Change in patient consideration of termination of pregnancy from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. | 14 days | Change in patient consideration of termination of pregnancy (patient reported) from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. |
| Secondary | Request for dosage increase in the three different groups. | 14 days | Frequency of request for dosage increase in the three different groups. |
| Secondary | Request for continuation of trial medication after end of intervention in the three different groups. | 14 days | Frequency of request for continuation of trial medication after end of intervention in the three different groups. |
| Secondary | Use of rescue medication during the intervention in the three different groups. | 14 days | Use of rescue medication during (patient reported) the intervention in the three different groups. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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