Metoclopramide versus prochlorperazine for hyperemesis gravidarum

ISRCTN	ISRCTN52681225
DOI	https://doi.org/10.1186/ISRCTN52681225
Protocol serial number	732.20
Sponsor	University of Malaya (Malaysia)
Funder	University of Malaya (Malaysia)

Submission date: 13/11/2009
Registration date: 17/02/2011
Last edited: 17/02/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Peng Chiong Tan
Scientific

Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Study information

Primary study design	Interventional
Study design	Double blind randomised trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	Metoclopramide versus prochlorperazine for hyperemesis gravidarum: a double blind randomised trial
Study acronym	MetPro Trial
Study objectives	Prochlorperazine is as effective as metoclopramide for hyperemesis gravidarum.
Ethics approval(s)	University of Malaya Medical Centre Medical Ethics Committee approved on the 31st July 2009
Health condition(s) or problem(s) studied	Hyperemesis gravidarum
Intervention	Metoclopramide (10 mg) or prochlorperazine (12.5 mg) intravenously 8-hourly for 24 hours.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Prochlorperazine, metoclopramide
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	05/11/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	128
Key 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
Key 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
Date of first enrolment	06/11/2009
Date of final enrolment	05/11/2010

Locations

Countries of recruitment

Malaysia

Study participating centre

Department of Obstetrics and Gynaecology

Kuala Lumpur
50603
Malaysia

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes