Metoclopramide versus prochlorperazine for hyperemesis gravidarum

Completed

• Conditions: Hyperemesis gravidarum; Pregnancy and Childbirth; Excessive vomiting in pregnancy

• Registration Number: ISRCTN52681225
• Lead Sponsor: niversity of Malaya (Malaysia)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-17
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

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

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Satisfaction score at 24 hours using a self-administered 10 point visual numerical rating scale (VNRS)<br>2. Frequency of vomiting during the 24 hours study period

Secondary Outcome Measures

Name	Time	Method
1. Nausea scores measured using a 10 point VNRS at enrolment, 8 hours, 16 hours and 24 hours <br>2. Ketonuria status at the end of study period<br>3. Addition or change of anti-emetic required during the study period <br>4. Admission to discharge interval<br>5. Time to discontinuation of IV fluids<br>6. Time to discontinuation of IV anti-emetics<br>7. Any adverse events<br>8. Self administered side effects profile at end of study period - symptoms of:<br>8.1. Drowsiness<br>8.2. Inability to sleep<br>8.3. Dry mouth<br>8.4. Dizziness<br>8.5. Diarrhoea<br>8.6. Headache<br>8.7. Palpitations<br>8.8. Uncontrollable movements or muscle spasms<br>8.9. Rash