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Oral versus intravenous rehydration in management of women with morning sickness

Oral Rehydration therapy versus IntraVenous rehydration therapy in the first 12 hours following hospitalisation for hyperemesis gravidarum: a multicentre randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN40152556
Enrollment
220
Registered
2020-12-06
Start date
2021-02-10
Completion date
Unknown
Last updated
2024-02-27

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 Hyperemesis gravidarum

Interventions

Participants will be randomized into two arms (1:1) via labeled envelopes which will be given to the participants upon recruitment. Randomization will be generated by a random sequence generator, prov

Sponsors

University of Malaya Medical Centre
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Current primary outcome measure as of 22/07/2021: 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 2. Weight (g) measured at baseline and 12 h 3. Improvement of ketonuria measured using urine samples collected at baseline and 12 h Previous primary outcome measure: 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 2. Weight (g) measured at baseline and 12 h 3. Improvement of ketonuria measured using blood samples collected at baseline and 12 h

Secondary

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

Countries

Malaysia

Contacts

Public ContactWan Nurul Ezyani Wan Jabarudin
ezyani@gmail.com+60 143384851

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 7, 2026