Oral versus intravenous rehydration in management of women with morning sickness
| ISRCTN | ISRCTN40152556 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40152556 |
| Secondary identifying numbers | Protocol version 1.1 |
- Submission date
- 22/11/2020
- Registration date
- 06/12/2020
- Last edited
- 16/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aim.
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 of 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), which 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, 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). Participants in both groups are encouraged to eat as much as tolerated. 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 hours.
At the end of the 12 hours duration, urine and blood samples will be taken again, and weight will be recorded. Participant’s satisfaction scores will also be obtained. If at any time the participants feel that they are unable to tolerate the oral rehydration salts, or become unwell, they will be given necessary treatment. 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 January 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
Contact information
Scientific
Jalan Universiti
Kuala Lumpur
59100
Malaysia
| Phone | +60 127440731 |
|---|---|
| maherah@ummc.edu.my |
Public
8, Jalan GP 3/4
Gombak
68100
Malaysia
| Phone | +60 143384851 |
|---|---|
| ezyani@gmail.com |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Oral Rehydration therapy versus IntraVenous rehydration therapy in the first 12 hours following hospitalisation for hyperemesis gravidarum: a multicentre randomised controlled trial |
| Study acronym | ORIV |
| Study objectives | 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(s) | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 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 study start date | 01/04/2020 |
| Completion date | 06/01/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 220 participants |
| Total final enrolment | 124 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/02/2021 |
| Date of final enrolment | 06/01/2023 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
Department of Obstetrics and Gynaecology
Jalan Universiti
Kuala Lumpur
59100
Malaysia
| Phone | +60 379494422 |
|---|---|
| szawiah@um.edu.my | |
| Website | https://www.um.edu.my/ |
"ROR" |
https://ror.org/00rzspn62 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 30/01/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Other |
| Publication and dissemination plan | Planned publication in a high-impact journal. Please use the contact details below to request a protocol. |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3 | 17/07/2021 | 06/03/2023 | No | No |
| Results article | 15/02/2024 | 16/02/2024 | Yes | No |
Additional files
Editorial Notes
16/02/2024: Publication reference added.
06/03/2023: The following changes were made to the trial record:
1. The study design was changed from 'Multicenter interventional randomized controlled trial' to 'Single-center interventional randomized controlled trial'.
2. The recruitment start date has been changed from 15/12/2020 to 10/02/2021.
3. The recruitment end date has been changed from 30/10/2023 to 06/01/2023.
4. The overall trial end date has been changed from 31/12/2023 to 06/01/2023 and the plain English summary has been updated to reflect the changes above.
5. Total final enrolment and protocol file (not peer reviewed) added.
6. Hospital Ampang was removed from the trial participating centres.
02/09/2022: The intention to publish date was changed from 30/09/2022 to 30/01/2024.
22/07/2021: The primary outcome measure has been updated.
21/07/2021: The plain English summary has been updated.
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.
