Condition category
Pregnancy and Childbirth
Date applied
17/07/2008
Date assigned
31/07/2008
Last edited
27/04/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peng Chiong Tan

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

625.10

Study information

Scientific title

Acronym

PRO-MET Trial

Study hypothesis

Intravenous metoclopramide is superior to intravenous promethazine as an anti-emetic in hyperemesis gravidarum

Ethics approval

University of Malaya Medical Centre Medical Ethics Committee approved on the 21st of November 2007 (ref: 625.10)

Study design

Randomised double-blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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 names

Metoclopramide, promethazine

Primary outcome measures

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)

Secondary outcome measures

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

Overall trial start date

01/09/2008

Overall trial end date

01/03/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

128

Participant 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

Recruitment start date

01/09/2008

Recruitment end date

01/03/2010

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

Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor type

University/education

Website

http://um.edu.my

Funders

Funder type

University/education

Funder name

University of Malaya (Malaysia) (Grant ref: PJP/FS227/2008B)

Alternative name(s)

University of Malaya, UM

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Malaysia

Funder name

CCM Duopharma Malaysia Biotech Berhad (Malaysia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20410771

Publication citations

  1. Results

    Tan PC, Khine PP, Vallikkannu N, Omar SZ, Promethazine compared with metoclopramide for hyperemesis gravidarum: a randomized controlled trial., Obstet Gynecol, 2010, 115, 5, 975-981, doi: 10.1097/AOG.0b013e3181d99290.

Additional files

Editorial Notes