search
Back to results

Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum (VOMIT)

Primary Purpose

Hyperemesis Gravidarum, Nausea Gravidarum, Vomiting of Pregnancy

Status
Terminated
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Mirtazapine
Ondansetron
Placebo
Sponsored by
Nordsjaellands Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperemesis Gravidarum focused on measuring Hyperemesis Gravidarum (HG), Mirtazapine, Ondansetron, Pregnancy, Nausea and Vomiting of Pregnancy (NVP), Randomized Controlled Trial (RCT)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

    1. weight loss >5% of pre-pregnancy weight and/or
    2. hospitalisation due to nausea and vomiting of pregnancy
  • Singleton pregnancy
  • The subject must be willing and able to comply with trial protocol

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Gynaecology and Obstetrics, Aarhus University Hospital
  • Department of Gynaecology and Obstetrics, Rigshospitalet
  • Department of Gynaecology and Obstetrics, Herlev Hospital
  • Department of Gynaecology and Obstetrics, Nordsjællands Hospital
  • Department of Gynaecology and Obstetrics, Hvidovre Hospital
  • Department of Gynaecology and Obstetrics, Kolding Sygehus
  • Department of Gynaecology and Obstetrics, Odense University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Mirtazapine

Ondansetron

Placebo

Arm Description

Mirtazapine 15 mg oral tablet (incapsulated in gelatine to provide blinding) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered once daily (morning). On Day 7 dosage increase is optional. If desired, mirtazapine 30 mg oral tablet (incapsulated in gelatine) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered three times daily (morning, noon and late afternoon). In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.

Ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered twice daily (morning and bedtime) for 7 days. On Day 7 dosage increase is optional. If desired, ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.

Placebo oral tablet (empty gelatine capsule) will be administered twice daily (morning and bedtime) for 7 days. On Day 7 dosage increase is optional. If desired, placebo oral tablet (empty gelatine capsule) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Request for dosage increase in the three different groups.
Frequency of request for dosage increase in the three different groups.
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.
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.
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
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.
Need of hospitalisation during the intervention in the three different groups.
Number of days of hospitalisations during the intervention in the three different groups.
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.
Pregnancy outcome: Live birth, loss or termination of pregnancy
Live birth, loss or termination of pregnancy.
Delivery outcome: Mode of delivery
Mode of delivery: Vaginal, cesarian, vacuum extraction.
Delivery outcome: Delivery complications
Eg. postpartum hemorrhage, shoulder dystocia, sphincter rupture
Live birth outcome: birth weight.
Birth weight in g.
Live birth outcome: gestational age at birth.
Gestational age at birth in weeks plus days.
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.
Live birth outcome: umbilical cord pH.
Umbilical cord pH at birth.
Live birth outcome: placenta weight.
placenta weight in g.
Live birth outcome: sex.
offsprings sex.
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.
Live birth outcome: congenital malformations (depending on gestational age also registered on early ended pregnancies).
Congenital malformations.
Occurrence of treatment failure in the three different groups.
Frequency of and time to treatment failure in the three different groups.

Full Information

First Posted
November 13, 2018
Last Updated
January 26, 2023
Sponsor
Nordsjaellands Hospital
Collaborators
Bispebjerg Hospital, Aarhus University Hospital, Herlev and Gentofte Hospital, Hvidovre University Hospital, Odense University Hospital, Rigshospitalet, Denmark, Regionernes Medicinpulje, Kolding Sygehus
search

1. Study Identification

Unique Protocol Identification Number
NCT03785691
Brief Title
Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum
Acronym
VOMIT
Official Title
Validating the Effect of Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum: A Double-Blind Randomised Placebo-Controlled Multicentre Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Terminated
Why Stopped
Recruiting difficulties
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
July 31, 2022 (Actual)
Study Completion Date
July 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nordsjaellands Hospital
Collaborators
Bispebjerg Hospital, Aarhus University Hospital, Herlev and Gentofte Hospital, Hvidovre University Hospital, Odense University Hospital, Rigshospitalet, Denmark, Regionernes Medicinpulje, Kolding Sygehus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 be randomized to treatment with either mirtazapine, ondansetron or placebo (1:1:1).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperemesis Gravidarum, Nausea Gravidarum, Vomiting of Pregnancy
Keywords
Hyperemesis Gravidarum (HG), Mirtazapine, Ondansetron, Pregnancy, Nausea and Vomiting of Pregnancy (NVP), Randomized Controlled Trial (RCT)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized placebo controlled multicenter trial testing already marketed drugs on a new indication.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All oral tablets will be encapsulated in gelatine to ensure identical look, smell and taste.
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mirtazapine
Arm Type
Experimental
Arm Description
Mirtazapine 15 mg oral tablet (incapsulated in gelatine to provide blinding) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered once daily (morning). On Day 7 dosage increase is optional. If desired, mirtazapine 30 mg oral tablet (incapsulated in gelatine) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered three times daily (morning, noon and late afternoon). In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.
Arm Title
Ondansetron
Arm Type
Experimental
Arm Description
Ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered twice daily (morning and bedtime) for 7 days. On Day 7 dosage increase is optional. If desired, ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo oral tablet (empty gelatine capsule) will be administered twice daily (morning and bedtime) for 7 days. On Day 7 dosage increase is optional. If desired, placebo oral tablet (empty gelatine capsule) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.
Intervention Type
Drug
Intervention Name(s)
Mirtazapine
Other Intervention Name(s)
KRKA Mirtazapine Oral Tablet
Intervention Description
Mirtazapine 15 mg oral tablet (incapsulated in gelatine to provide blinding) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered once daily (morning). On Day 7 dosage increase is optional. If desired, mirtazapine 30 mg oral tablet (incapsulated in gelatine) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered three times daily (morning, noon and late afternoon). In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Bluefish Ondansetron Oral Tablet
Intervention Description
Ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered twice daily (morning and bedtime) for 7 days. On Day 7 dosage increase is optional. If desired, ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo Oral Tablet
Intervention Description
Placebo oral tablet (empty gelatine capsule) will be administered twice daily (morning and bedtime) for 7 days. On Day 7 dosage increase is optional. If desired, placebo oral tablet (empty gelatine capsule) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days.
Primary Outcome Measure Information:
Title
Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the placebo group.
Description
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.
Time Frame
2 days
Title
Change in nausea and vomiting from baseline to Day 2 (short term) in the ondansetron group versus the placebo group.
Description
Change in PUQE-24 score (patient reported) from baseline to Day 2 (short term) in the ondansetron group versus the placebo group.
Time Frame
2 days
Title
Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the mirtazapine group versus the placebo group.
Description
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.
Time Frame
14 days
Title
Change in nausea and vomiting from baseline to Day 14(+/-1) (long term) in the ondansetron group versus the placebo group.
Description
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.
Time Frame
14 days
Title
Change in nausea and vomiting from baseline to Day 2 (short term) in the mirtazapine group versus the ondansetron group.
Description
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.
Time Frame
2 days
Secondary Outcome Measure Information:
Title
Change in nausea and vomiting from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group.
Description
Change in PUQE-24 score (patient reported) from baseline to Day 14(+/-1) in the mirtazapine group versus the ondansetron group.
Time Frame
14 days
Title
Overall nausea and vomiting during the intervention in the three different groups.
Description
Area under the curve for PUQE-24 score (patient reported) during the intervention in the three different groups.
Time Frame
14 days
Title
Change in well-being during the intervention in the three different groups.
Description
Change in PUQE well-being score (patient reported) during the intervention in the three different groups.
Time Frame
14 days
Title
Change in nausea during the intervention in the three different groups.
Description
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.
Time Frame
14 days
Title
Change in vomiting during the intervention in the three different groups.
Description
Change in number of daily vomiting episodes (patient reported) during the intervention in the three different groups.
Time Frame
14 days
Title
Occurrence of side effects in the three different groups.
Description
Occurrence of side effects (patient reported and registered by trial personnel) during and until 5 days after the intervention in the three different groups.
Time Frame
19 days
Title
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.
Description
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.
Time Frame
14 days
Title
Change in severity of hyperemesis gravidarum from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Description
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.
Time Frame
14 days
Title
Change in health-related quality of life from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Description
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.
Time Frame
14 days
Title
Change in sleep quality from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Description
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.
Time Frame
14 days
Title
Patient satisfaction with treatment Day 7(+/-1) and Day 14(+/-1) in the three different groups.
Description
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.
Time Frame
14 days
Title
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.
Description
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.
Time Frame
14 days
Title
Request for dosage increase in the three different groups.
Description
Frequency of request for dosage increase in the three different groups.
Time Frame
14 days
Title
Request for continuation of trial medication after end of intervention in the three different groups.
Description
Frequency of request for continuation of trial medication after end of intervention in the three different groups.
Time Frame
14 days
Title
Use of rescue medication during the intervention in the three different groups.
Description
Use of rescue medication during (patient reported) the intervention in the three different groups.
Time Frame
14 days
Title
Number of days on sick leave during the intervention in the three different groups
Description
Number of days on sick leave (patient reported) during the intervention in the three different groups
Time Frame
14 days
Title
Necessity of i.v.-fluids during the intervention in the three different groups.
Description
Amount of treatments with i.v.-fluids during the intervention in the three different groups.
Time Frame
14 days
Title
Need of hospitalisation during the intervention in the three different groups.
Description
Number of days of hospitalisations during the intervention in the three different groups.
Time Frame
14 days
Title
Weight change from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Description
Weight change in kg from baseline to Day 7(+/-1) and baseline to Day 14(+/-1) in the three different groups.
Time Frame
14 days
Title
Pregnancy outcome: Live birth, loss or termination of pregnancy
Description
Live birth, loss or termination of pregnancy.
Time Frame
8 months
Title
Delivery outcome: Mode of delivery
Description
Mode of delivery: Vaginal, cesarian, vacuum extraction.
Time Frame
8 months
Title
Delivery outcome: Delivery complications
Description
Eg. postpartum hemorrhage, shoulder dystocia, sphincter rupture
Time Frame
8 months
Title
Live birth outcome: birth weight.
Description
Birth weight in g.
Time Frame
8 months
Title
Live birth outcome: gestational age at birth.
Description
Gestational age at birth in weeks plus days.
Time Frame
8 months
Title
Live birth outcome: APGAR score.
Description
APGAR score at 1, 5 and 10 minutes after birth. APGAR score ranges 0-10 with 0 being worse and 10 being better.
Time Frame
8 months
Title
Live birth outcome: umbilical cord pH.
Description
Umbilical cord pH at birth.
Time Frame
8 months
Title
Live birth outcome: placenta weight.
Description
placenta weight in g.
Time Frame
8 months
Title
Live birth outcome: sex.
Description
offsprings sex.
Time Frame
8 months
Title
Live birth outcome: hospitalizations on neonatal ward during the first month post-partum.
Description
Hospitalizations of the offspring in neonatal ward during the first month post-partum.
Time Frame
9 months
Title
Live birth outcome: congenital malformations (depending on gestational age also registered on early ended pregnancies).
Description
Congenital malformations.
Time Frame
8 months
Title
Occurrence of treatment failure in the three different groups.
Description
Frequency of and time to treatment failure in the three different groups.
Time Frame
14 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Ostenfeld, MD
Organizational Affiliation
Department of Obstetrics and gynecology, Nordsjællands Hospital Hillerød
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Gynaecology and Obstetrics, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Department of Gynaecology and Obstetrics, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Department of Gynaecology and Obstetrics, Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Department of Gynaecology and Obstetrics, Nordsjællands Hospital
City
Hillerød
ZIP/Postal Code
3400
Country
Denmark
Facility Name
Department of Gynaecology and Obstetrics, Hvidovre Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Facility Name
Department of Gynaecology and Obstetrics, Kolding Sygehus
City
Kolding
ZIP/Postal Code
6000
Country
Denmark
Facility Name
Department of Gynaecology and Obstetrics, Odense University Hospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to patient level data and supporting clinical documents may be requested. Requests will be reviewed on the basis of methodological proposal. Patient data will be de-identified to protect the privacy of trial patients in line with applicable laws and regulations.
IPD Sharing Time Frame
Following publication, no end date.
Citations:
PubMed Identifier
32209630
Citation
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.
Results Reference
derived

Learn more about this trial

Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum

We'll reach out to this number within 24 hrs