Intravenous metoclopramide versus intravenous promethazine for hyperemesis gravidarum: a double-blind, randomised trial
| ISRCTN | ISRCTN34918844 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN34918844 |
| Secondary identifying numbers | 625.10 |
- 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
Scientific
Department of Obstetrics and Gynaecology
Faculty of Medicine
University of Malaya
Kuala Lumpur
50603
Malaysia
Study information
| Study design | Randomised double-blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Metoclopramide, promethazine |
| Primary outcome measure | 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 study start date | 01/09/2008 |
| Completion date | 01/03/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
50603
Malaysia
Sponsor information
University of Malaya (Malaysia)
University/education
University/education
Lembah Pantai
Kuala Lumpur
50603
Malaysia
| Website | http://um.edu.my |
|---|---|
"ROR" |
https://ror.org/00rzspn62 |
Funders
Funder type
University/education
University of Malaya (Malaysia) (Grant ref: PJP/FS227/2008B)
Government organisation / Universities (academic only)
Government organisation / Universities (academic only)
- Alternative name(s)
- University of Malaya, University Malaya, Malayan University, UM
- Location
- Malaysia
CCM Duopharma Malaysia Biotech Berhad (Malaysia)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2010 | Yes | No |
