Ondansetron versus metoclopramide for hyperemesis gravidarum

Completed

• Conditions: Hyperemesis gravidarum - excessive vomiting in pregnancy; Pregnancy and Childbirth; Mild hyperemesis gravidarum

• Registration Number: ISRCTN00592566
• Lead Sponsor: niversity of Malaya (Malaysia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-08
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 128

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Visual numerical rating scale score of overall wellbeing at 24 hours<br>2. Frequency of vomiting in the first 24 hours

Secondary Outcome Measures

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