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Ondansetron versus metoclopramide for hyperemesis gravidarum

Ondansetron versus metoclopramide For hyperemesis gravidarum: a randomized trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN00592566
Enrollment
128
Registered
2012-05-08
Start date
2012-11-07
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 - excessive vomiting in pregnancy Pregnancy and Childbirth Mild hyperemesis gravidarum

Interventions

Intervention: Participants will receive either 4mg ondansetron every 8 hours or 10mg metoclopramide every 8 hours for 24 hours intravenously. Participants will also receive standard intravenous rehydr

Sponsors

University of Malaya (Malaysia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. First hospitalization for hyperemesis gravidarum (severe nausea and vomiting of pregnancy) 2. Gestation 16 weeks or less 3. Clinical dehydration with ketonuria on dipstick 4. Women in their first hospitalisation for presumed hyperemesis gravidarum

Exclusion criteria

Exclusion criteria: 1. Multiple gestation 2. Established non viable pregnancy 3. Pre-existing medical condition which can cause nausea and vomiting if known, for example: 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. Allergy to metoclopramide or ondansetron

Design outcomes

Primary

MeasureTime frame
1. Visual numerical rating scale score of overall wellbeing at 24 hours 2. Frequency of vomiting in the first 24 hours

Secondary

MeasureTime frame
1. Visual numerical rating scale score for nausea at enrolment, 8,16 and 24 hours 2. Adverse symptom profile 3. Ketonuria status at the end of 24 hour period 4. Treatment curtailment and changes 5. Total antiemetic drug dose 6. Length of hospital stay

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 20, 2026