Nausea and Vomiting in pregnancy Hyperemesis gravidarum
Conditions
Interventions
Trade Name: Metoclopramide MCP-ratiopharm® SF 10 mg / 2 ml injection solution
Product Name: Metoclopramide MCP-ratiopharm® SF 10 mg / 2 ml injection solution
Pharmaceutical Form: Solution for injectio
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The exclusion criteria for the EMPOWER study are as follows: • Allergy/hypersensitivity to any of the study drugs • Prior treatment with the study drugs in this pregnancy • Pre-existing diagnosis of medical condition: type 1 and 2 diabetes, chronic kidney disease (CKD) stage 3-5, Graves’ disease, significant cardiac disease (including long QT syndrome), phaeochromocytoma, epilepsy (or other seizure disorder). • Moderate renal impairment (known CKD 3b/4/5 or Cr > 100 in pregnancy) • Severe liver impairment (ALT / AST > 150) • Severe diarrhoea (definition >10 loose, watery stools in a day (24 hours))* • Hypokalaemia** • Vomiting caused by another underlying condition/infection • Concomitant use of apomorphine, serotonergic drugs (e.g. selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, lithium) *If a woman who has severe diarrhoea (as defined above) meets other inclusion criteria and is subsequently found to have a serum potassium > 3 mmol/L and has not yet been prescribed an antiemetic it would be reasonable to offer participation in EMPOWER. **all women with severe NVP will have routine assessment of 'Urea & Electrolytes' - in the absence of severe diarrhoea women can be approached, consented and given study treatments before results are available. If the serum potassium is subsequently found to be low (=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: The exclusion criteria for the EMPOWER study are as follows: • Allergy/hypersensitivity to any of the study drugs • Prior treatment with the study drugs in this pregnancy • Pre-existing diagnosis of medical condition: type 1 and 2 diabetes, Chronic kidney disease (CKD) stage 3-5, Graves’ disease, significant cardiac disease (including long QT syndrome), phaeochromocytoma, epilepsy (or other seizure disorder). • Moderate renal impairment (known CKD 3b/4/5 or Cr > 100 in pregnancy) • Severe liver impairment (ALT / AST > 150) • Severe diarrhoea (definition >10 loose, watery stools in a day (24 hours))* • Hypokalaemia** • Vomiting caused by another underlying condition/infection • Concomitant use of apomorphine, serotonergic drugs (e.g. selective serotonin reuptake inhibitors, monoamine oxidase inhibitors, lithium) *If a woman who has severe diarrhoea (as defined above) meets other inclusion criteria and is subsequently found to have a serum potassium > 3 mmol/L and has not yet been prescribed an antiemetic it would be reasonable to offer participation in EMPOWER. **all women with severe NVP will have routine assessment of 'Urea & Electrolytes' - in the absence of severe diarrhoea women can be approached, consented and given study treatments before results are available. If the serum potassium is subsequently found to be low (<3 mmol/L) they should not be withdrawn from the trial but the hypokalaemia corrected quickly with intravenous supplementation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether, in addition to IV rehydration, ondansetron vs placebo ondansetron and metoclopramide vs placebo metoclopramide reduces the rate of treatment failure up to 10 days after initiation. ;Secondary Objective: The inclusion criteria for the EMPOWER study are as follows: • Pregnant women suffering from severe NVP • Gestation =16 6/7 weeks (16 weeks 6 days) • Taken first line antiemetic treatment (cyclize, chlorpromazine, promethazine or prochlorperazine as recommended by the RCOG [10]), as prescribed i.e. full course taken by participant in the current pregnancy with no sustained improvement in symptoms (over a minimum of 24 hours use) • Age =18 years • Able to give informed consent • Able to read/understand written English ;Primary end point(s): The primary endpoint is the number of participants experiencing a treatment failure. Treatment failure is defined as the need for further treatment as a participant’s symptoms have worsened between 12 hours and 10 days post treatment initiation. If further treatment is required a participant should be placed on a third line antiemetic treatment i.e. high dose ondansetron or corticosteroids. Participants cannot be given metoclopramide or low dose ondansetron as third line antiemetic treatment initiation. ;Timepoint(s) of evaluation of this end point: The timepoints of this evaluation are between 12 hours and 10 days post treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints for the EMPOWER study are as follows: Participant reported symptom severity: The PUQE score will be used to assess severity of symptoms. The scale quantifies the amount of nausea, vomiting and retching experienced over the previous 24 hours. The PUQE score will be collected at baseline, 48 hours, 5 days and 10 days post treatment commencing. Participant reported severity of nausea: We will use a visual analogue score (VAS) for nausea alongside the PUQE symptoms severity score to examine more subtle changes in nausea. The VAS asks participants to rate, on a scale of 0-10 where 10 is the worst possible nausea you could feel, how bad their nausea is now. The VAS score will be collected at baseline, 48 hours, 5 days and 10 days post treatment commencing. NVPQOL: The Health-Related Quality of Life for Nausea and Vomiting during Pregnancy (NVPQOL) provides a total score and those in 4 domains (physical symptoms and aggravating factors; fatigue; emotions; limitations). The NVPQOL will be collected at baseline and 10 days post treatment commencing. Of primary interest will be the total NVPQOL score. Anxiety, depression and social support: These parameters will be measured using the following scales which are validated for use in pregnancy: Edinburgh Post-natal Depression Scale (EPDS). State Trait Anxiety Inventory [STAI]: Maternity Social Support scale: Data will be collected as the total EPDS score (depression) and total STAI score (anxiety) at baseline and 10 days. The total maternal social support scale score will be reported at baseline. Clinical indicators of anti-emetic effectiveness (a) The number of participants experiencing a treatment failure (as per primary endpoint) at 48 hours (b) Relapse rate at 5 and 10 days (defined as a PUQE score of = 6 at 48 hours followed by an increase to > 12 at 5 / 10 days) (c) Remission rate at 10 days (defined as a PUQE score of = 6 at 48 hours with return to persistent sy | — |
Countries
United Kingdom
Contacts
Public ContactNicola Goudie
Newcastle University Clinical Trials Unit
Outcome results
None listed