Metoclopramide versus prochlorperazine for hyperemesis gravidarum

ISRCTN ISRCTN52681225
DOI https://doi.org/10.1186/ISRCTN52681225
Secondary identifying numbers 732.20
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

Study designDouble blind randomised trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleMetoclopramide versus prochlorperazine for hyperemesis gravidarum: a double blind randomised trial
Study acronymMetPro Trial
Study objectivesProchlorperazine 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) studiedHyperemesis gravidarum
InterventionMetoclopramide (10 mg) or prochlorperazine (12.5 mg) intravenously 8-hourly for 24 hours.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Prochlorperazine, metoclopramide
Primary outcome measure1. 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 measures1. 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 study start date06/11/2009
Completion date05/11/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participantsAt least 128 women
Key inclusion criteria1. 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 criteria1. 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 enrolment06/11/2009
Date of final enrolment05/11/2010

Locations

Countries of recruitment

  • Malaysia

Study participating centre

Department of Obstetrics and Gynaecology
Kuala Lumpur
50603
Malaysia

Sponsor information

University of Malaya (Malaysia)
University/education

University of Malaya Medical Centre
Department of Obstetrics and Gynaecology
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Website http://www.um.edu.my/
ROR logo "ROR" https://ror.org/00rzspn62

Funders

Funder type

University/education

University of Malaya (Malaysia)
Government organisation / Universities (academic only)
Alternative name(s)
University of Malaya, University Malaya, Malayan University, UM
Location
Malaysia

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan