Food tasting trial in women admitted for severe nausea and vomiting of pregnancy
| ISRCTN | ISRCTN74788811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74788811 |
| Secondary identifying numbers | 2017106-5653 |
- Submission date
- 15/12/2017
- Registration date
- 24/12/2017
- Last edited
- 18/01/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English Summary
Background and study aims
Hyperemesis gravidarum (HG) is a fairly common condition in early pregnancy that casues a lot of nausea and vomiting that usually leads to hospitalization because women are dehydrated, starved and unable to self sustain adequate oral intake. Certain foods might provoke the vomiting and nausea and there may be certain foods that are more tolerable for women with HG. The aim of this study is to evaluate the response of women with HG to food items identified from a previous questionnaire based HG study in our centre that indicates they might represent better tolerated food. The food items to be tested in this trial, apple, watermelon, bread and crackers) are listed in order of likelihood of being better tolerated. The data obtained may provide experimental data to aid in the construction of evidence based dietary advice for women affected by HG. The aim of this study is to find the superior food item from the list of 4 in terms of tolerability and agreeability in our trial participants affected by HG.
Who can participate?
Women aged 18 and older who are admitted to in University Malaya Medical Centre, Malaysia for HG.
What does the study involve?
Each participants is required to taste and eat, in random order all the four trial food items, each of standard bite size portions in presence of the investigator and observed for 10 minutes after each food has been chewed and swallowed. Participants are asked to score the severity of their nausea using a scale before tasting, two and 10 minutes after each food items. They are required after tasting each item to record their nausea score, vomit response (if any) and the food agreeability score of the food they have just tasted. Between each test, participants rinse their mouth and have a gap of two minutes to recuperate.
What are the possible benefits and risks of participating?
There may be no immediate direct benefit but it is possible that participants may discover a food type that is suitable for them. There are no immediate risks involved except that they may feel nauseated or vomit during the food tasting.
Where is the study run from?
University Malaya Medical Centre (Malaysia)
When is the study starting and how long is it expected to run for?
December 2017 to December 2018
Who is funding the study?
Obstetrics and Gynaecological Department of University Malaya Medical Centre (Malaysia)
Who is the main contact?
1. Dr. Tan Gi Ni (Scientific)
tangn@ummc.edu.my
2. Professor Peng Chiong Tan (Scientific)
Contact information
Scientific
Pusat Perubatan Universiti Malaya
Lembah Pantai
Kuala Lumpur
59100
Malaysia
Scientific
University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
Study information
| Study design | This is a single-centre trial that involves tasting of four food items given in random order to each participant with hyperemesis gravidarum |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Food tasting trial in women admitted for hyperemesis gravidarum |
| Study hypothesis | We postulate that apple will be best tolerated followed by watermelon, bread and crackers in women hospitalised for hyperemesis gravidarum. |
| Ethics approval(s) | Medical Research Ethics Committee, University of Malaya Medical Centre, 31/10/2017, ref: MREC ID No: 2017106-5653 |
| Condition | Hyperemesis Gravidarum |
| Intervention | The intervention involves food tasting of four food items given in random order to each participant (within subject analysis) with hyperemesis gravidarum. Food tasting requires ingestion of a standard bite size portion of a food item as stated below: 1. One slice of red watermelon (Weight approximately 20 grams ) 2. A slice of plain white bread with the crusts cut off 1 cm within (Approximately 5 x 5 cm in size) 3. A slice of red apple, (Weight approximately: 20 grams, Fuji Apple) 4. Quarter piece of Jacobs Cream Crackers (Manufacturer: Nestle) Participants are monitored for 10 minutes after each food item is tasted before proceed to the next food item. The order of food items tasted will be randomized in order to minimize effects from being influenced by the previous food items. |
| Intervention type | Other |
| Primary outcome measure | 1. Nausea score is measured using the visual numerical rating scale from 0 to 10 at 2 and 10 minutes of tasting each food item 2. Agreeability score on each food item tasted is measured using a visual numerical rating scale from 0 to 10 at ten minutes after each food item is ingested |
| Secondary outcome measures | Urges to vomit, heave or gag are measured using observations "in" 10 minutes after each food item is ingested. |
| Overall study start date | 01/06/2017 |
| Overall study end date | 30/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 72 |
| Total final enrolment | 72 |
| Participant inclusion criteria | 1. Patients admitted with a presumed diagnosis of hyperemesis gravidarum 2. Confirmed clinical pregnancy (at least a positive pregnancy test if gestational sac is not yet visible on ultrasound) 3. Gestation less than 16 weeks 4. Age 18 years old and above 5. Patient is within 24 hours of first admission for hyperemesis gravidarum in the current pregnancy |
| Participant exclusion criteria | 1. Inability to participate or consume the food due to extreme symptoms 2. Confirmed non-viable pregnancy 3. Known taste or swallowing disorder 4. Any allergies to food items tested |
| Recruitment start date | 09/01/2018 |
| Recruitment end date | 03/07/2018 |
Locations
Countries of recruitment
- Malaysia
Study participating centre
Kuala Lumpur
59100
Malaysia
Sponsor information
Hospital/treatment centre
Department of Obstetrics and Gynaecology
University of Malaya Medical Center
Lembah Pantai
Kuala Lumpur
59100
Malaysia
"ROR" |
https://ror.org/00rzspn62 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication a peer reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from: Name of investigator 1: Dr. Tan Gi Ni Affiliation : University of Malaya Medical Centre, Malaysia Email Address: tan_gi_ni@hotmail.com Name of investigator 2: Professor Dr. Tan Peng Chiong Affiliation: University of Malaya Medical Centre, Malaysia Email Address: pctan@um.edu.my |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 27/01/2021 | 27/01/2021 | No | No | |
| Results article | 13/05/2021 | 18/01/2023 | Yes | No |
Additional files
- ISRCTN74788811_BasicResults_27Jan2021.pdf
- uploaded 27/01/2021
Editorial Notes
18/01/2023: Publication reference added.
27/01/2021: The basic results of this trial have been uploaded as an additional file.
15/08/2019: The recruitment start date was changed from 20/12/2017 to 09/01/2018.
17/07/2018: The following changes have been made to the trial record:
1. The recruitment end date has been changed from 30/06/2018 to 03/07/2018
2. The intention to publish date has been changed from 31/12/2018 to 31/12/2019
