Condition category
Pregnancy and Childbirth
Date applied
19/05/2019
Date assigned
24/05/2019
Last edited
24/05/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Hyperemesis Gravidarum (HG) is the severe form of nausea and vomiting in pregnancy (NVP), which affects about 0.3–3.6% of pregnant women. HG is defined as the symptom of nausea and/or vomiting during early pregnancy where there are no other causes. It affects up to 80% of pregnant women and is one of the most common indications for hospital admission in early pregnancy. Our study aims to determine that watermelon in their diet improves the recovery in HG patients by improving hydration status which is evaluated by changes in body weight after hospital discharge. This will provide scientific data to construct standard dietary advice for women with HG. This study is derived from a recently completed study in our centre and the result show watermelon is well tolerated by HG patients.

Who can participate?
Patients who are getting discharged from hospital admission for hyperemesis gravidarum.

What does the study involve?
Patients will be randomized into control and intervention group upon discharge from ward. The intervention group will be given a dietary advice leaflet, watermelon and weighing scale to bring back home and control group will receive a dietary leaflet and weighing scale. All patient will be weighed and need to answer a Simplified Nutritional Appetite Questionnaire (SNAQ) and Pregnancy-Unique Quantification of Emesis (PUQE) questionnaire. Patients are required to take watermelon before each meal or snack on whenever needed. 1 and 2 weeks after discharge, patients will be interviewed through phone calls, they required to provide body weight measurements, SNAQ and PUQE score will be reevaluated.

What are the possible benefits and risks of participating?
Benefits: patient will have weight gain by improving their appetite There is no risk factor

Where is the study run from?
University Malaya Medical Centre, Kuala Lumpur, Malaysia.

When is the study starting and how long is it expected to run for?
Patients will start to be recruited from 01/06/2019 and the study will end around 31/12/2019.

Who is funding the study?
Research committee, Department of Obstetrics and Gynaecology, University Malaya medical centre.

Who is the main contact?
Dr. Gayaithiri Ramasandran
gayaithiri_r@yahoo.com

Trial website

N/A

Contact information

Type

Scientific

Primary contact

Dr Gayaithiri Ramasandran

ORCID ID

http://orcid.org/0000-0003-3305-645X

Contact details

University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
03-7949 4422
gayaithiri@siswa.um.edu.my

Type

Scientific

Additional contact

Dr neha sethi naresh sethi

ORCID ID

Contact details

Jalan Universiti
Lembah Pantai
Kuala lumpur
50603
Malaysia
+60173702555
s_neha26@yahoo.com

Type

Scientific

Additional contact

Prof Tan Peng Chiong

ORCID ID

Contact details

Jalan Universiti
Lembah Pantai
Kuala lumpur
50603
Malaysia
+60123052970
tanpengchiong@yahoo.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

NMRR:-19-546-47548

Study information

Scientific title

The effect of standard dietary advice in hyperemesis gravidarum patients: a randomised prospective trial

Acronym

N/A

Study hypothesis

Watermelon in the diet of HG women improves body weight gain after hospital discharge

Ethics approval

Approved 21/05/2019, the Medical Research Ethics Committee of University Malaya Medical Centre (Medical Research Ethics Committee, University of Malaya Medical Centre, Lembah Pantai, 59100, Kuala Lumpur, Malaysia; 03-7949 3209; umrec@um.edu.my), ref: 2019327-7262.

Study design

Prospective randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled 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

1. All patients who are being discharged from gynaecology ward with diagnosis of hyperemesis gravidarum will be screened on the day of discharge, using the Eligibility Form and patients who fulfilled study criteria will be approached to participate.
2. All participants will be provided with patient information sheet. Participant is encouraged to ask question about the trial.
3. Written consent will be taken from all who agree to participate in this study.
4. Each participant will be interviewed by the investigator and information obtained including from clinical notes will be transcribed to the Case Report Form.
5. Randomization will be generated using random number generator at Random.org in random block of 4 or 8 by investigator who is not involved in recruitment.
6. The random allocation sequence will be placed in sealed numbered opaque envelopes for strict number order assignment to participants. Randomization is by effected opening the lowest remaining numbered sealed envelope just prior to discharge.
7. Participant will be randomized to watermelon (intervention) group or control group.
8. All participants required to measure body weight before discharge using a digital weighing scale which is provided with one layer thin clothing, empty the bladder, and remove the shoes and other accessories. Also required to complete SNAQ and PUQE form on the day of hospital discharge.
9. Each participant will be given a dietary advice leaflet recommended for HG patients and a digital weighing scale to bring home.
10. Participant who is randomized into trial group will be provided with 2 whole watermelons to be taken home. Standard preparation and storage protocol will be provided. Patient will be requested to take 1/8th of a whole watermelon (approximately 500g) in a day in separate portions before each meal for 2 weeks from hospital discharge and to snack on watermelon if desired.
11. Participants will be contacted through phone calls at 1 week and 2 weeks after discharge. They will be interviewed; required to provide body weight measurements, measured using the digital scale given following the standard protocol provided, SNAQ and PUQE score will be reevaluated.
12. Data collection by the investigator will be completed when case report forms and outcome forms are completed.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Change in body weight in 1st week and 2nd week after hospital discharge compared to body weight at discharge.

Secondary outcome measures

1. Poor appetite evaluated by using Simplified Nutritional Appetite Questionnaire (SNAQ) score at 1 week and 2 weeks after hospital discharge
2. Pregnancy-Unique Quantification of Emesis (PUQE) score 1 week and 2 weeks after discharge.

Overall trial start date

01/03/2019

Overall trial end date

31/12/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Admitted with a diagnosis of HG.
2. Confirmed clinical pregnancy (at least a positive pregnancy test if an intra-uterine gestational sac is not yet visible on ultrasound).
3. Gestation less than 16 weeks.
4. Age 18 years old and above.
5. First admission in current pregnancy for HG.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

128

Participant exclusion criteria

1. Confirmed non-viable pregnancy.
2. Allergy or intolerance to watermelon.
3. Aversion to watermelon.
4. Multiple gestations.

Recruitment start date

01/06/2019

Recruitment end date

30/11/2019

Locations

Countries of recruitment

Malaysia

Trial participating centre

university malaya medical centre
Jalan Universiti, Lembah Pantai,
Kuala lumpur
50603
Malaysia

Sponsor information

Organisation

University Malaya Medical Centre

Sponsor details

Department of obstetric & gynaecology
Jalan Universiti
Lembah Pantai
Kuala lumpur
50603
Malaysia
07949 2077
fomadmin@um.edu.my

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University 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 peer-reviewed journal.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

01/12/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

24/05/2019: Trial's existence confirmed by the Medical Research Ethics Committee, University Malaya Medical Centre.