Hyperemesis gravidarum Pregnancy and Childbirth Excessive vomiting in pregnancy
Conditions
Interventions
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.
Sponsors
University of Malaya (Malaysia)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Malaysia
Outcome results
None listed