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Does Ondansetron vs placebo Ondansetron and Metoclopramide vs placebo Metoc... | Recruiting
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Does Ondansetron vs placebo Ondansetron and Metoclopramide vs placebo Metoclopramide (in addition to IV rehydration) reduce the rate of treatment failure in women suffering from nausea and vomiting in pregnancy
EMPOWER

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Medical Conditions
  • Reproductive Health and Childbirth
Primary Contact Details
Dr Nicola Goudie
+44 191 2087187
See all trial contact details
Recruitment Status
Recruiting
Trial source and source ID number
ISRCTN16924692
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Summary
Background and study aims
Around 30% of women suffer from moderate to severe nausea and vomiting in pregnant (NVP), causing physical and emotional distress and reducing quality of life (QOL). The most severe form, hyperemesis gravidarum (HG), affects up to 3% of women, leading to dehydration, weight loss and nutrient deficiency. Moderate or severe NVP requires medical treatment, but care varies in different hospitals as some women have reported feeling unsupported, dissatisfied, anxious and depressed. The aim of this study is to compare the effectiveness of two drugs (metoclopramide and ondansetron) for treating women with severe symptoms of nausea and vomiting in pregnancy (NVP) who have already tried using one anti-sickness drug but without improvement in their symptoms.

Who can participate?
Women attending hospital with severe NVP, 16+6 weeks pregnant or less, who have had little or no improvement whilst taking initial (first line) anti-sickness treatment.

What does the study involve?
Participants are randomly allocated to one of groups. Those in the first group receive metoclopramide with a placebo (dummy medication). Those in the second group receive ondansetron with a placebo. Those in the third group receive metoclopramide and ondansetron. Those in the last group receive a double placebo. The medications are initially given into a vein three times a day for up to four days. Once women are able drink without vomiting, the same drugs are given by tablet for up to ten days. Participants are monitored and if at any point after 12 hours of treatment starting symptoms have not improved, the study drugs are deemed to have failed and the medical staff prescribes a third line antiemetic treatment. Patients are also offered the opportunity to take part in an interview. Both women who take part and those that decline are offered the opportunity to take part. These interviews are being carried out to help us understand the patient’s reason for participating or not participating in a complex trial of medication in pregnancy.

What are the possible benefits and risks of participating?
The study may not directly benefit participants but the study treatment in combination with IV rehydration may help alleviate their NVP symptoms. The information we gain from this study may help other patients in the future. Participants will also be more closely monitored and have follow up phone calls to check how they are doing, which would not normally happen. Participants may become sick again at the end of the 10 days when the study drugs are stopped. If this happens the participant can contact the doctors or midwives at the hospital or one of the research team members for advice. The research team and the participants will not know which of the study drugs the participant has received so if the participant felt better while taking part in the study, they will not be able to necessarily give them what they received while in the study. Participants will therefore be given whatever drug is normally given as part of standard care. This will probably be ondansetron or metoclopramide. Both drugs might cause side effects such as: drowsiness, restlessness, constipation, diarrhoea, headache, dizziness, visual disturbance (e.g., blurred vision), light headedness, irregular heart rhythm, (fast or slow), rash, itching, sensation of flushing. Metoclopramide very occasionally causes muscle spasms. In rare cases ondansetron and metoclopramide may react with some other prescription medication, such as antidepressants, sedatives, morphine, medication for epilepsy and some antibiotics. During the research study we will collect information about any reactions or side effects. Metoclopramide and ondansetron are licensed for use but not in pregnancy. However there is enough evidence for doctors to believe they are safe and both drugs are routinely used to treat pregnant women.

Where is the study run from?
This study is being run by the Newcastle University (UK) and takes place in hospitals in the UK.

When is the study starting and how long is it expected to run for?
September 2017 to January 2022

Who is funding the study?
National Institute for Health Research (UK)

Who is the main contact?
Dr Nicola Goudie (Scientific)
nicola.goudie@ncl.ac.uk
Research Details
  • The aim of this trial is to compare the effectiveness of two drugs (metoclopramide and ondansetron) for treating women with severe symptoms of nausea and vomiting in pregnancy (NVP) who have already tried using one anti-sickness drug but without improvement in their symptoms.
Phase
Phase III
Study Design
Randomised; Interventional; Design type: Treatment, Drug
Study Type
Interventional
Intervention

Participants initially receive the study drug via IV, they receive IV treatment 3 times per day, once they are able to tolerate liquids they are converted to oral treatment which they take three times daily. Participant can be allocated to one of four treatment groups – these are outlined below with details of the dosage they are given:
1. Metoclopramide (10 mg three times daily via IV and then tablets) + placebo (via IV and then tablets)
2. Ondansetron (4 mg three times daily via IV and then tablets) + placebo (via IV and then tablets)
3. Metoclopramide (10 mg three times daily (via IV and then tablets) + ondansetron (4 mg three times daily via IV and then tablets)
4. Double placebo three times daily (via IV and then tablets)

The study drug is initially given intravenously for up to four days. Once the women are able to tolerate fluids, the same drugs are given by tablet for up to ten days. Treatment lasts a maximum of ten days in total.

Follow up takes place at 48 hours post first dose of IMP, then at 5 days and the final follow up questionnaires at 10 days. Participants are then be followed up post birth via a review of their medical records.

Intervention Type
Other
Primary Outcome Measures
    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.
Secondary Outcome Measures
    1. Participant reported symptom severity is measured using PUQE at 48 hours, 5 days and 10 days post treatment commencing.
    2. Participant reported severity of nausea is measured using VAS for nausea at 48 hours, 5 days and 10 days post treatment commencing.
    3. Quality of life is measured using NVPQOL (Health-Related Quality of Life for Nausea and Vomiting during Pregnancy) at baseline and 10 days post treatment commencing
    4. Anxiety, depression and social support will be measured using Edinburgh post-natal depression scale (EPDS) and State Trait Anxiety Inventory [STAI] at baseline and 10 days
    5. Anxiety, depression and social support will also be measured using the Maternity Social Support scale at baseline.
    6. Clinical indicators of anti-emetic effectiveness is measured via:
    6.1. Number of participants experiencing a treatment failure at 48 hours
    6.2. 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)
    6.3. Remission rate at 10 days (defined as a PUQE score of ≤ 6 at 48 hours with return to persistent symptoms [PUQE
    score of 7 or above] at 10 days)
    6.4. Readmission rates (the number of participants readmitted with NVP within 10 days of recruitment and between 10
    days of recruitment and 20 weeks of pregnancy)
    6.5. Total in-patient days related to NVP between recruitment and 20 weeks of pregnancy and between 20 weeks of
    pregnancy and delivery
    6.6. Additional antiemetic use
    7. Side effects and adverse events is measured by asking participants about the occurrence of side effects and adverse events at 48 hours, 5 days and 10 days
    8. Pregnancy and neonatal outcomes will be gathered via a chart review at 20 weeks gestation and birth
Publication(s)
Sorry, this information is not available
Result Reports
Sorry, this information is not available
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Gender
Female
Age Range
Adult
Who Can Participate
Patient
Number of Participants
Planned Sample Size: 600; UK Sample Size: 600
Participant Inclusion Criteria
    1. Pregnant women suffering from severe NVP (nausea and vomiting in pregnancy)
    2. Gestation ≤166/7 weeks
    3. Taken first line antiemetic treatment (cyclize, chlorpromazine, promethazine or prochlorperazine as recommended by the RCOG), 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)
    4. Age ≥18 years
    5. Able to give informed consent
    6. Able to read/understand written English
Participant Exclusion Criteria
    1. Allergy/hypersensitivity to any of the study drugs
    2. Prior treatment with the study drugs in this pregnancy
    3. 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).
    4. Moderate renal impairment (known CKD 3b/4/5 or Cr > 100 in pregnancy)
    5. Severe liver impairment (ALT / AST > 150)
    6. Severe diarrhoea (definition > 10 loose, watery stools in a day (24 hours))*
    7. Hypokalaemia**
    8. Vomiting caused by another underlying condition/infection
    9. 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.
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Trial Location(s)
Newcastle upon Tyne
NE1 4LP
Sunderland
SR4 7TP
Middlesbrough
TS4 3BW
London
SW17 0QT
London
SE1 7EH
Birmingham
B15 2TG
Leeds
LS9 7TF
Bradford
BD9 6RJ
Trial Contact(s)
Primary Trial Contact
Dr Nicola Goudie
+44 191 2087187
Other Trial Contacts
Sorry, this information is not available
Countries Recruiting
United Kingdom
This information is designed to help you decide whether this trial is of interest. In some cases it is provided as a link to more detailed patient information or it may still be awaited from the organisation running the trial. Please look again shortly if the information you need is not here or, if named, contact the researcher named above.
Scientific Title
EMPOWER: EMesis in Pregnancy - Ondansetron With mEtoclopRamide
EudraCT Number
2017-001651-31
Funder(s)
  • National Institute for Health Research
Other Study ID Numbers
36233
Sponsor(s)
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Key Dates

Recruitment Start Date

01 Feb 2018

Recruitment End Date

31 Jul 2020

Trial Start Date

01 Sep 2017

Trial End Date

31 Jan 2022

Date added to source

08 Jan 2018

Date updated in source

29 Mar 2019