Oral versus intravenous rehydration in management of women with morning sickness

Not Applicable

Completed

• Conditions: Hyperemesis gravidarum; Pregnancy and Childbirth

• Registration Number: ISRCTN40152556
• Lead Sponsor: niversity of Malaya Medical Centre

Brief Summary

2024 Results article in https://doi.org/10.1002/ijgo.15429 (added 16/02/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-06
• Study Completion: 2023-01-06
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

1. Aged =18 years
2. Confirmed pregnancy by urine pregnancy test and presence of intrauterine sac
3. Clinical diagnosis of hyperemesis gravidarum, with presence of ketonuria of at least 2+ on admission
4. Gestation age less than 14 weeks
5. First hospital admission for hyperemesis gravidarum, and within 2 h of admission, where rehydration therapy has not formally been commenced

Exclusion Criteria

1. Allergy to oral rehydration salts
2. Women with an underlying medical disorder (including diabetes mellitus, hypertension, heart disease, renal disease, and endocrine disorder such as hyperthyroid disorder)
3. Multiple pregnancy
4. Proven non viable pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 22/07/2021:<br>1. Patients satisfaction with allocated rehydration regime using VNRS scale (Visual Numerating Rating Score) from 0 to 10, with 0 being the worst score) at 12 h<br>2. Weight (g) measured at baseline and 12 h<br>3. Improvement of ketonuria measured using urine samples collected at baseline and 12 h<br><br><br>Previous primary outcome measure:<br>1. Patients satisfaction with allocated rehydration regime using VNRS scale (Visual Numerating Rating Score) from 0 to 10, with 0 being the worst score) at 12 h<br>2. Weight (g) measured at baseline and 12 h<br>3. Improvement of ketonuria measured using blood samples collected at baseline and 12 h

Secondary Outcome Measures

Name	Time	Method
1. Hospital admission to discharge interval measured at the point of discharge<br>2. Nausea measured using serial nausea score at 0, 4, 8, and 12 h<br>3. Treatment preference measured using Likert’s scale on the preference of treatment at 12 h<br>4. Deviation from protocol measured from investigators notes at the point of discharge<br>5. Hematocrit (Hct), electrolytes level measured using blood samples collected at 12 h