Dextrose saline versus saline solution infused for the initial rehydration of hyperemesis gravidarum

ISRCTN ISRCTN65014409
DOI https://doi.org/10.1186/ISRCTN65014409
Secondary identifying numbers 811.8
Submission date
26/04/2012
Registration date
16/05/2012
Last edited
30/11/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Peng Chiong Tan
Scientific

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

Study information

Study designDouble-blind randomised intervention trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleDextrose saline versus saline solution infused for the initial rehydration of hyperemesis gravidarum: a randomized trial
Study acronymDexSal Trial
Study objectivesRehydration 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(s)University Malaya Medical Centre Ethics Committee, 22/09/2010, ref: 811.8
Health condition(s) or problem(s) studiedHyperemesis gravidarum
InterventionThree litres of 5% dextrose-0.9% saline or three litres of 0.9% saline solution infused intravenously over 24 hours.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)5% dextrose, 0.9% saline
Primary outcome measure1. Resolution of ketonuria at 24 hours (using urine dipstick)
2. Well being at 24 hours using a Visual Numerical Rating scale (VNRS)
Secondary outcome measures1. 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 study start date09/11/2010
Completion date09/02/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target number of participantsAt least 200 women
Key inclusion criteria1. 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
Key exclusion criteria1. 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)
Date of first enrolment09/11/2010
Date of final enrolment09/02/2012

Locations

Countries of recruitment

  • Malaysia

Study participating centre

University of Malaya
Kuala Lumpur
50603
Malaysia

Sponsor information

University of Malaya (Malyasia)
University/education

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

Website http://www.um.edu.my/
ROR logo "ROR" https://ror.org/00rzspn62

Funders

Funder type

University/education

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2013 Yes No