Condition category
Pregnancy and Childbirth
Date applied
13/11/2009
Date assigned
17/02/2011
Last edited
17/02/2011
Prospective/Retrospective
Retrospectively 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
Lembah Pantai
Kuala Lumpur
50603
Malaysia

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

http://www.um.edu.my/

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

Publication citations

Additional files

Editorial Notes