Plain English Summary
Background and study aims
Hyperemesis gravidarum (HG) is a complication of pregnancy that involves severe nausea and vomiting, and is one of the commonest causes for hospital admission in pregnancy. HG can also lead to dizziness, dehydration and weight loss. Rehydration and correction of electrolyte imbalance in the blood is the goal the management of hyperemesis. These are usually achieved using fluid supplementation intravenously (into the vein) in the hospital. Another option for rehydration therapy would be Oral Rehydration Salts (ORS) (taken by mouth), are easily available, easily prepared, and self-administered. The aim of this study is to compare the response in terms of patient’s satisfaction and ability to improve hydration with oral rehydration therapy compared to intravenous rehydration therapy.
Who can participate?
Healthy pregnant women aged 18 or over will be invited to participate in this study. Participants with a viable pregnancy, in their first trimester, for their first hospital admission with nausea and vomiting in pregnancy will be suitable. Pregnant women with medical problems, multiple pregnancy or allergies to the oral rehydration salts will be excluded from the study.
What does the study involve?
Participants will be randomly allocated into two groups where one group will receive oral rehydration therapy (taken by mouth) and the other group will receive intravenous rehydration therapy (via a small plastic tube into a vein in the arm) and will need to fast for 12 h before. On admission, participants weight, vital signs and baseline investigation (using a blood and urine sample) will be recorded. Vital signs and nausea experienced by participants will be recorded every 4 h.
At the end of the 12 h duration, urine and blood samples will be taken again, and weight will be recorded. Participants satisfaction score will also be obtained. If at anytime the participants feel that they need to eat, are unable to tolerate the oral rehydration salts, or become unwell, they will be allowed food and given necessary treatment, and may switch treatment group. These circumstances will be recorded.
What are the possible benefits and risks of participating?
Participants will receive the benefit of the treatment of their hyperemesis. The possible risks are low, but participants may develop allergies to the components of the oral rehydration salt.
Where is the study run from?
The Department of Obstetrics & Gynaecology, University Malaya Medical Centre (Malaysia)
When is the study starting and how long is it expected to run for?
From April 2020 to December 2023
Who is funding the study?
The Department of Obstetrics & Gynaecology, University Malaya Medical Centre (Malaysia)
Who is the main contact?
1. Dr Maherah binti Kamarudin
maherah@ummc.edu.my
2. Dr Wan Nurul Ezyani binti Wan Jabarudin
ezyani@gmail.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Maherah Kamarudin
ORCID ID
Contact details
Jalan Universiti
Kuala Lumpur
59100
Malaysia
+60 127440731
maherah@ummc.edu.my
Type
Public
Additional contact
Dr Wan Nurul Ezyani Wan Jabarudin
ORCID ID
Contact details
8
Jalan GP 3/4
Gombak
68100
Malaysia
+60 143384851
ezyani@gmail.com
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Protocol version 1.1
Study information
Scientific title
Oral Rehydration therapy versus IntraVenous rehydration therapy in the first 12 hours following hospitalisation for hyperemesis gravidarum: a multicentre randomised controlled trial
Acronym
ORIV
Study hypothesis
Although intravenous (IV) rehydration is superior to oral rehydration therapy (ORT) in improving ketonuria, ORT will have greater patient satisfaction and will also result in the resolution of ketonuria in the initial management of hyperemesis gravidarum.
Ethics approval
Approved 07/04/2020, Medical Research Ethics Committee, of the University Malaya Medical Centre (Lembah Pantai, 59100 Kuala Lumpur, Malaysia; +60 (0)3-79493209 ext. 2251; no email contact), ref: 2020212-8283
Study design
Multicenter interventional randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Condition
Hyperemesis gravidarum
Intervention
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, provided by random.org. to avoid bias.
Participants will be hospitalised and will receive either:
1. Standard intravenous rehydration (1.5L of 0.9% saline or HM solution over 12 h, run at 125 cc/h)
2. Oral rehydration therapy (diluted in 250 cc of water every 4 h) for a period of 12 h
Intervention type
Mixed
Phase
Drug names
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 outcome measures
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
Overall trial start date
01/04/2020
Overall trial end date
31/12/2023
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
220 participants
Participant 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
Recruitment start date
15/12/2020
Recruitment end date
30/10/2023
Locations
Countries of recruitment
Malaysia
Trial participating centre
University Malaya Medical Centre
Jalan Universiti
Kuala Lumpur
59100
Malaysia
Trial participating centre
Hospital Ampang
Jalan Mewah Utara
Taman Pandan Mewah
Ampang Jaya
68000
Malaysia
Sponsor information
Organisation
University of Malaya Medical Centre
Sponsor details
Department of Obstetrics and Gynaecology
Jalan Universiti
Kuala Lumpur
59100
Malaysia
+60 379494422
szawiah@um.edu.my
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University of Malaya Medical Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact journal. Please use the contact details below to request a protocol.
IPD sharing statement:
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication
Intention to publish date
30/09/2022
Participant level data
Other
Basic results (scientific)
Publication list