Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
732.20
Study information
Scientific title
Metoclopramide versus prochlorperazine for hyperemesis gravidarum: a double blind randomised trial
Acronym
MetPro Trial
Study hypothesis
Prochlorperazine is as effective as metoclopramide for hyperemesis gravidarum.
Ethics approval
University of Malaya Medical Centre Medical Ethics Committee approved on the 31st July 2009
Study design
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
Intervention
Metoclopramide (10 mg) or prochlorperazine (12.5 mg) intravenously 8-hourly for 24 hours.
Intervention type
Drug
Phase
Not Applicable
Drug names
Prochlorperazine, metoclopramide
Primary outcome measures
1. Satisfaction score at 24 hours using a self-administered 10 point visual numerical rating scale (VNRS)
2. Frequency of vomiting during the 24 hours study period
Secondary outcome measures
1. Nausea scores measured using a 10 point VNRS at enrolment, 8 hours, 16 hours and 24 hours
2. Ketonuria status at the end of study period
3. Addition or change of anti-emetic required during the study period
4. Admission to discharge interval
5. Time to discontinuation of IV fluids
6. Time to discontinuation of IV anti-emetics
7. Any adverse events
8. Self administered side effects profile at end of study period - symptoms of:
8.1. Drowsiness
8.2. Inability to sleep
8.3. Dry mouth
8.4. Dizziness
8.5. Diarrhoea
8.6. Headache
8.7. Palpitations
8.8. Uncontrollable movements or muscle spasms
8.9. Rash
Overall trial start date
06/11/2009
Overall trial end date
05/11/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Females aged over 16 years
2. First hospitalisation for hypermesis gravidarum in current pregnancy
3. Gestation less than 20 weeks
4. Clinically dehydrated with ketonuria
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
At least 128 women
Participant exclusion criteria
1. Multiple gestation
2. Proven non viable pregnancy
3. Pre-existing medical condition that can cause nausea and vomiting, e.g.:
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. Allergies to metoclopramide or prochlorperazine
Recruitment start date
06/11/2009
Recruitment end date
05/11/2010
Locations
Countries of recruitment
Malaysia
Trial participating centre
Department of Obstetrics and Gynaecology
Kuala Lumpur
50603
Malaysia
Sponsor information
Organisation
University of Malaya (Malaysia)
Sponsor details
University of Malaya Medical Centre
Department of Obstetrics and Gynaecology
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Sponsor type
University/education
Website
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
government non-federal
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
Results - basic reporting
Publication summary