Condition category
Pregnancy and Childbirth
Date applied
26/04/2012
Date assigned
16/05/2012
Last edited
30/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Hyperemesis gravidarum (HG) is severe nausea and vomiting occurring during pregnancy. It is fairly common, affecting about 2% of pregnant women, and hospital admission is needed for treatment. HG can lead to dehydration and starvation. The main treatment for HG is intravenous rehydration (fluids given directly into a vein through a drip). It is not known which fluid is best for the initial treatment of HG. Normal saline solution contains salt in the same concentration as blood. Dextrose-saline solution in addition to salt also contains dextrose (a form of sugar). Dextrose will provide calories at a time when the patient is not likely to be drinking or eating properly yet due to HG, which may allow a quicker recovery from starvation. The amount of glucose that we intend to administer over the 24-hour study period is probably about half of the carbohydrate intake in an average woman’s diet when she is eating normally. We are investigating whether the addition of dextrose to the intravenous solution used to treat women at the point of their hospitalisation for HG will result in a quicker recovery from starvation and make the patient feel better faster.

Who can take part?
Women aged 18 and over, hospitalised for the first time in their current pregnancy due to uncomplicated HG, and no more than 16 weeks pregnant.

What does the study involve?
Participants are randomly allocated to receive either normal saline solution or dextrose-saline solution.

What are the possible benefits and risks of participating?
In HG patients with severe thiamine deficiency (which can occur after prolonged starvation), dextrose infusion can cause a condition called Wernicke’s encephalopathy. To prevent this, before starting rehydration, all participants will receive a multivitamin intravenous injection containing thiamine.

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?
November 2010 to February 2012.

Who is funding the study?
University Malaya Medical Centre, Kuala Lumpur, Malaysia.

Who is the main contact?
Prof P C Tan

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peng Chiong Tan

ORCID ID

Contact details

University of Malaya
Department of Obstetrics and Gynaecology
Faculty of Medicine
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

811.8

Study information

Scientific title

Dextrose saline versus saline solution infused for the initial rehydration of hyperemesis gravidarum: a randomized trial

Acronym

DexSal Trial

Study hypothesis

Rehydration with the intravenous infusion of 5% dextrose-0.9% saline is hypothesised to result in a quicker resolution of ketonuria and generate a higher level of perceived well being compared to 0.9% saline.

Ethics approval

University Malaya Medical Centre Ethics Committee, 22/09/2010, ref: 811.8

Study design

Double-blind randomised intervention 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 below to request a patient information sheet

Condition

Hyperemesis gravidarum

Intervention

Three litres of 5% dextrose-0.9% saline or three litres of 0.9% saline solution infused intravenously over 24 hours.

Intervention type

Drug

Phase

Not Applicable

Drug names

5% dextrose, 0.9% saline

Primary outcome measures

1. Resolution of ketonuria at 24 hours (using urine dipstick)
2. Well being at 24 hours using a Visual Numerical Rating scale (VNRS)

Secondary outcome measures

1. Correction of hyponatraemia (≥ 136 mmol/l)
2. Correction of hypochloraemia (≥ 100 mmol/l)
3. Hyperglycaemia (any glucose level ≥ 8 mmol/l)
4. Nausea score at enrollment, 8. 16 and 24 hours (using VNRS)
5. Duration of intravenous (i.v.) rehydration during hospitalisation
6. Doses of of i.v. anti-emetic
7. Admission to discharge interval

Overall trial start date

09/11/2010

Overall trial end date

09/02/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Clinical hyperemesis gravidarum with dehydration
2. Age ≥ 18 years
3. Pregnancy less than 16 weeks of gestation
4. A positive urine pregnancy test if pregnancy not confirmed by ultrasound
5. Urine ketone at least 1+ on admission
6. First admission for hyperemesis gravidarum in current pregnancy
7. Venous plasma glucose ≤ 6 mmol/l
8. Venous sodium ≥ 125 mmol/l

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

At least 200 women

Participant exclusion criteria

1. Molar pregnancy
2. Women with underlying medical problem eg established gestational hypertension, diabetes, heart disease, renal disease, thyroid disorder
3. Suspected gastrointestinal causes of nausea and vomiting e.g. gastritis, gastroenteritis, peptic ulcer
4. Established non viable pregnancy
5. Preexisting medical condition that can cause or exarcebate nausea and vomiting (eg culture proven symptomatic urinary tract infection, dengue fever)

Recruitment start date

09/11/2010

Recruitment end date

09/02/2012

Locations

Countries of recruitment

Malaysia

Trial participating centre

University of Malaya
Kuala Lumpur
50603
Malaysia

Sponsor information

Organisation

University of Malaya (Malyasia)

Sponsor details

Department of Obstetrics and Gynaecology
Faculty of Medicine
Lembah Pantai
Kuala Lumpur
50603
Malaysia

Sponsor type

University/education

Website

http://www.um.edu.my/

Funders

Funder type

University/education

Funder name

Department of Obstetrics and Gynaecology, University of Malaya (Malyasia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23232754

Publication citations

  1. Results

    Tan PC, Norazilah MJ, Omar SZ, Dextrose saline compared with normal saline rehydration of hyperemesis gravidarum: a randomized controlled trial., Obstet Gynecol, 2013, 121, 2 Pt 1, 291-298, doi: http://10.1097/AOG.0b013e31827c5e99.

Additional files

Editorial Notes