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
Scientific
Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Lembah Pantai
Kuala Lumpur
50603
Malaysia
Study information
| Study design | Double blind randomised trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Prochlorperazine, metoclopramide |
| Primary outcome measure | 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 study start date | 06/11/2009 |
| Completion date | 05/11/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | At least 128 women |
| 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
50603
Malaysia
Sponsor information
University of Malaya (Malaysia)
University/education
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" |
https://ror.org/00rzspn62 |
Funders
Funder type
University/education
University of Malaya (Malaysia)
Government organisation / Universities (academic only)
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
