Intravenous metoclopramide versus intravenous promethazine for hyperemesis gravidarum: a double-blind, randomised trial

ISRCTN	ISRCTN34918844
DOI	https://doi.org/10.1186/ISRCTN34918844
Protocol serial number	625.10
Sponsor	University of Malaya (Malaysia)
Funders	University of Malaya (Malaysia) (Grant ref: PJP/FS227/2008B), CCM Duopharma Malaysia Biotech Berhad (Malaysia)

Submission date: 17/07/2008
Registration date: 31/07/2008
Last edited: 27/04/2010

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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
Kuala Lumpur
50603
Malaysia

Study information

Primary study design	Interventional
Study design	Randomised double-blind trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	PRO-MET Trial
Study objectives	Intravenous metoclopramide is superior to intravenous promethazine as an anti-emetic in hyperemesis gravidarum
Ethics approval(s)	University of Malaya Medical Centre Medical Ethics Committee approved on the 21st of November 2007 (ref: 625.10)
Health condition(s) or problem(s) studied	Hyperemesis gravidarum
Intervention	10 mg metoclopramide intravenously versus 25 mg promethazine intravenously at 8 hourly intervals at hospitalisation for hyperemesis gravidarum for up to 24 hours or longer as required.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Metoclopramide, promethazine
Primary outcome measure(s)	1. Participant well-being over the initial 24-hour period by means of a 10 point visual analogue scale (VAS) 2. Number of vomiting episodes in the initial 24-hour period (participant diary)
Key secondary outcome measure(s)	1. Nausea score measured using a 10 point VAS at enrolment, 8 , 16 and 24 hours 2. Ketonuria status at the end of 24 study period 3. Additional/ change of anti-emetic required during the study period and during hospitalisation 4. Total doses of intravenous anti-emetic needed during hospitalisation 5. Admission to discharge interval 6. Any adverse events, including side effects profile including symptoms of the following: 6.1. Drowsiness 6.2. Inability to sleep 6.3. Dry mouth 6.4. Dizziness 6.5. Diarrhoea 6.6. Headache 6.7. Palpitations 6.8. Uncontrollable movements or muscle spasms 6.9. Rash
Completion date	01/03/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	128
Key inclusion criteria	1. Pregnant women, age limit >17 to 50 years 2. Gestation <16 weeks 3. First hospitalisation for hyperemesis gravidarum in current pregnancy 4. Clinical dehydration with ketonuria on urine dipstick
Key exclusion criteria	1. Multiple gestation 2. Established non viable pregnancy 3. Allergy to metoclopramide or promethazine 4. Pre-exiting medical condition which can cause nausea and vomiting if known, for example: 4.1. Concomitant confounders of severity of nausea and vomiting e.g. culture proven symptomatic urinary tract infection, dengue fever 4.2. Gastrointestinal causes of vomiting e.g. gastro-enteritis 4.3. Medical causes of vomiting e.g. diabetic ketoacidosis
Date of first enrolment	01/09/2008
Date of final enrolment	01/03/2010

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?
Results article	results	01/05/2010		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes