Plain English Summary
Background and study aims:
Hyperemesis gravidarum (HG) is a pregnancy related condition characterized by severe nausea and vomiting, weight loss and electrolyte disturbance requiring a stay in hospital for treatment.
Metoclopramide is a common first line medication used in the treatment of HG aiming to reduce nausea and vomiting. Ondansetron is a similar drug. Ondansetron is more effective than metoclopramide in other settings e.g. during chemotherapy and after surgery. The experience with ondansetron in the treatment of HG is not as large as that with metoclopramide but available data suggest that both metoclopramide and ondansetron do not cause problems for the baby.
It is not known in context of treatment for HG, which agent, metoclopramide or ondansetron is more effective or has fewer side effects.
We are doing a study comparing metoclopramide with ondansetron during the initial 24 hours of inpatient treatment for HG. Treatment after this 24 hour study period will revert to the standard treatment for HG.
The aim is to investigate whether ondansetron is more effective than metoclopramide in the initial treatment of HG in producing greater well being, reducing vomiting and nausea or has less side effects.
Who can participate?
Women hospitalised for the first time in the current pregnancy due to uncomplicated HG who is aged 18 years and above and not more than 16 weeks pregnant can take part.
What does the study involve?
All women hospitalised with HG in our centre receive an anti emetic medication intravenously in their initial treatment. You will be randomly assigned to receive either metoclopramide or ondansetron given intravenously every 8 hours for 24 hours. You will need to fill in score sheets for well being, nausea and vomiting during the 24 hour study period
Randomisation means that you will have an equal chance of getting either medicine but the allocation will be decided by a chance process. Neither your doctor nor you will be informed which medicine you will receive (this process called blinding is to reduce bias). The nature of the medicine received by you will be released to your doctor if needed. Your doctor can still change, stop or add your medication.
What are the possible benefits and risks of participating?
Both ondansetron and metoclopramide are in common use for the treatment of HG. No major risk is anticipated. However, you may be allocated to treatment that may subsequently be shown by this study to be less effective and/or has more side effects.
Where is the study run from?
Ggynaecology Ward, University Malaya Medical Centre, Kuala Lumpur, Malaysia.
When is study starting and how long is it expected to run for?
November 2011 to May 2013
Who is funding the study?
Department of Obstetrics and Gynaecology, University Malaya Medical Centre
Who is the main contact?
Prof Siti Zawiah Omar
szawiah@um.edu.my
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
871.2
Study information
Scientific title
Ondansetron versus metoclopramide For hyperemesis gravidarum: a randomized trial
Acronym
Study hypothesis
Ondansetron compared to metoclopramide is a more effective anti emetic agent when used in the initial inpatient management of hyperemesis gravidarum with anticipated higher sense of well being and reduced frequency of vomiting at the end of 24 hour study period.
Ethics approval
University Malaya Medical Centre Medical Ethics Committee, 24 August 2011, ref: 871.2
Study design
Comparative groups in double blind randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Hyperemesis gravidarum - excessive vomiting in pregnancy
Intervention
Intervention: Participants will receive either 4mg ondansetron every 8 hours or 10mg metoclopramide every 8 hours for 24 hours intravenously. Participants will also receive standard intravenous rehydration. After 24 hours, open label standard treatment for hyperemesis gravidarum applies.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Visual numerical rating scale score of overall wellbeing at 24 hours
2. Frequency of vomiting in the first 24 hours
Secondary outcome measures
1. Visual numerical rating scale score for nausea at enrolment, 8,16 and 24 hours
2. Adverse symptom profile
3. Ketonuria status at the end of 24 hour period
4. Treatment curtailment and changes
5. Total antiemetic drug dose
6. Length of hospital stay
Overall trial start date
07/11/2012
Overall trial end date
06/05/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. First hospitalization for hyperemesis gravidarum (severe nausea and vomiting of pregnancy)
2. Gestation 16 weeks or less
3. Clinical dehydration with ketonuria on dipstick
4. Women in their first hospitalisation for presumed hyperemesis gravidarum
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
At least 128 women
Participant exclusion criteria
1. Multiple gestation
2. Established non viable pregnancy
3. Pre-existing medical condition which can cause nausea and vomiting if known, for example:
3.1. Concomitant confounders of severity of nausea and vomiting e.g. culture proven symptomatic urinary tract infection, dengue fever
3.2. Gastrointestinal causes of vomiting e.g. gastro-enteritis
3.3. Medical causes of vomiting e.g. diabetic ketoacidosis
3.4. Allergy to metoclopramide or ondansetron
Recruitment start date
07/11/2012
Recruitment end date
06/05/2013
Locations
Countries of recruitment
Malaysia
Trial participating centre
University of Malaya
Kuala Lumpur
50603
Malaysia
Sponsor information
Organisation
University of Malaya (Malaysia)
Sponsor details
Faculty of Medicine
Department of Obstetrics and Gynaecology
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Sponsor type
University/education
Website
http://medicine.um.edu.my/?modul=DEPARTMENTS&pilihan=Obstetrics_and_Gynecology
Funders
Funder type
University/education
Funder name
University of Malaya (Malaysia)
Alternative name(s)
University of Malaya, UM
Funding Body Type
government organisation
Funding Body Subtype
Local government
Location
Malaysia
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24807340
Publication citations
-
Results
Abas MN, Tan PC, Azmi N, Omar SZ, Ondansetron compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial., Obstet Gynecol, 2014, 123, 6, 1272-1279, doi: 10.1097/AOG.0000000000000242.