Condition category
Pregnancy and Childbirth
Date applied
15/12/2017
Date assigned
24/12/2017
Last edited
18/12/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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)

Trial website

Contact information

Type

Scientific

Primary contact

Dr Gi Ni Tan

ORCID ID

Contact details

Pusat Perubatan Universiti Malaya
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Type

Scientific

Additional contact

Prof Peng Chiong Tan

ORCID ID

Contact details

University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2017106-5653

Study information

Scientific title

Food tasting trial in women admitted for hyperemesis gravidarum

Acronym

Study hypothesis

We postulate that apple will be best tolerated followed by watermelon, bread and crackers in women hospitalised for hyperemesis gravidarum.

Ethics approval

Medical Research Ethics Committee, University of Malaya Medical Centre, 31/10/2017, ref: MREC ID No: 2017106-5653

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

Trial setting

Hospitals

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/06/2017

Overall trial end date

30/12/2018

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Female

Target number of participants

72

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

20/12/2017

Recruitment end date

30/06/2018

Locations

Countries of recruitment

Malaysia

Trial participating centre

University of Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Sponsor information

Organisation

University of Malaya

Sponsor details

Department of Obstetrics and Gynaecology
University of Malaya Medical Center
Lembah Pantai
Kuala Lumpur
59100
Malaysia

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Department of Obstetrics and Gynaecology, University of Malaya

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication a peer reviewed journal.

IPD sharing statement:
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

Intention to publish date

31/12/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes