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Metoclopramide versus prochlorperazine for hyperemesis gravidarum

Metoclopramide versus prochlorperazine for hyperemesis gravidarum: a double blind randomised trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN52681225
Enrollment
128
Registered
2011-02-17
Start date
2009-11-06
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperemesis gravidarum Pregnancy and Childbirth Excessive vomiting in pregnancy

Interventions

Metoclopramide (10 mg) or prochlorperazine (12.5 mg) intravenously 8-hourly for 24 hours.

Sponsors

University of Malaya (Malaysia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026