Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group. |
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. |
2 days |
|
Primary |
Change in nausea and vomiting from baseline to Day 2 (short term) in the ondansetron group versus the placebo group. |
Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the ondansetron group versus the placebo group. |
2 days |
|
Primary |
Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the mirtazapine group versus the placebo group. |
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. |
14 days |
|
Primary |
Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the ondansetron group versus the placebo group. |
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. |
14 days |
|
Primary |
Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group. |
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. |
2 days |
|
Secondary |
Change in nausea and vomiting from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group. |
Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group. |
14 days |
|
Secondary |
Overall nausea and vomiting during the intervention in the three different groups. |
Area under the curve for PUQE-24 score (patient reported) during the intervention in the three different groups. |
14 days |
|
Secondary |
Change in well-being during the intervention in the three different groups. |
Change in PUQE well-being score (patient reported) during the intervention in the three different groups. |
14 days |
|
Secondary |
Change in nausea during the intervention in the three different groups. |
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. |
14 days |
|
Secondary |
Change in vomiting during the intervention in the three different groups. |
Change in number of daily vomiting episodes (patient reported) during the intervention in the three different groups. |
14 days |
|
Secondary |
Occurrence of side effects in the three different groups. |
Occurrence of side effects (patient reported and registered by trial personnel) during and until 5 days after the intervention in the three different groups. |
19 days |
|
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. |
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. |
14 days |
|
Secondary |
Change in severity of hyperemesis gravidarum from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. |
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. |
14 days |
|
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. |
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. |
14 days |
|
Secondary |
Change in sleep quality from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. |
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. |
14 days |
|
Secondary |
Patient satisfaction with treatment Day 7(+/-1) and Day 14(+/-1) in the three different groups. |
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. |
14 days |
|
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. |
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. |
14 days |
|
Secondary |
Request for dosage increase in the three different groups. |
Frequency of request for dosage increase in the three different groups. |
14 days |
|
Secondary |
Request for continuation of trial medication after end of intervention in the three different groups. |
Frequency of request for continuation of trial medication after end of intervention in the three different groups. |
14 days |
|
Secondary |
Use of rescue medication during the intervention in the three different groups. |
Use of rescue medication during (patient reported) the intervention in the three different groups. |
14 days |
|
Secondary |
Number of days on sick leave during the intervention in the three different groups |
Number of days on sick leave (patient reported) during the intervention in the three different groups |
14 days |
|
Secondary |
Necessity of i.v.-fluids during the intervention in the three different groups. |
Amount of treatments with i.v.-fluids during the intervention in the three different groups. |
14 days |
|
Secondary |
Need of hospitalisation during the intervention in the three different groups. |
Number of days of hospitalisations during the intervention in the three different groups. |
14 days |
|
Secondary |
Weight change from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. |
Weight change in kg from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups. |
14 days |
|
Secondary |
Pregnancy outcome: Live birth, loss or termination of pregnancy |
Live birth, loss or termination of pregnancy. |
8 months |
|
Secondary |
Delivery outcome: Mode of delivery |
Mode of delivery: Vaginal, cesarian, vacuum extraction. |
8 months |
|
Secondary |
Delivery outcome: Delivery complications |
Eg. postpartum hemorrhage, shoulder dystocia, sphincter rupture |
8 months |
|
Secondary |
Live birth outcome: birth weight. |
Birth weight in g. |
8 months |
|
Secondary |
Live birth outcome: gestational age at birth. |
Gestational age at birth in weeks plus days. |
8 months |
|
Secondary |
Live birth outcome: APGAR score. |
APGAR score at 1, 5 and 10 minutes after birth. APGAR score ranges 0-10 with 0 being worse and 10 being better. |
8 months |
|
Secondary |
Live birth outcome: umbilical cord pH. |
Umbilical cord pH at birth. |
8 months |
|
Secondary |
Live birth outcome: placenta weight. |
placenta weight in g. |
8 months |
|
Secondary |
Live birth outcome: sex. |
offsprings sex. |
8 months |
|
Secondary |
Live birth outcome: hospitalizations on neonatal ward during the first month post-partum. |
Hospitalizations of the offspring in neonatal ward during the first month post-partum. |
9 months |
|
Secondary |
Live birth outcome: congenital malformations (depending on gestational age also registered on early ended pregnancies). |
Congenital malformations. |
8 months |
|
Secondary |
Occurrence of treatment failure in the three different groups. |
Frequency of and time to treatment failure in the three different groups. |
14 days |
|