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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN65014409
Enrollment
200
Registered
2012-05-16
Start date
2010-11-09
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperemesis gravidarum Pregnancy and Childbirth Hyperemesis gravidarum with metabolic disturbance

Interventions

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

Sponsors

University of Malaya (Malyasia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

Malaysia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 24, 2026