Condition category
Pregnancy and Childbirth
Date applied
22/11/2020
Date assigned
06/12/2020
Last edited
14/12/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

https://www.um.edu.my/

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

Publication citations

Additional files

Editorial Notes

14/12/2020: The following changes have been made: 1. The recruitment start date has been changed from 01/12/2020 to 15/12/2020 2. The recruitment end date has been changed from 30/03/2022 to 30/10/2023. 3. The overall trial end date has been changed from 30/03/2022 to 31/12/2023 and the plain English summary has been updated to reflect the changes above. 02/12/2020: Trial’s existence confirmed by the Medical Research Ethics Committee of the University of Malaya Medical Centre.