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Hyperemesis In Pregnancy (HIP) Trial: Inpatient versus outpatient management of severe nausea and vomiting in pregnancy

Not Applicable
Completed
Conditions
Hyperemesis gravidarum (severe nausea and vomiting of pregnancy)
Pregnancy and Childbirth
Registration Number
ISRCTN24659467
Lead Sponsor
Chelsea and Westminster NHS Trust (UK)
Brief Summary

2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29222135

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
120
Inclusion Criteria

Pregnant women up to 20 weeks gestation with symptoms of hyperemesis gravidarum and at least 1+ ketonuria on dipstick

Exclusion Criteria

1. Women greater than 20 weeks gestation
2. Women with another medical condition manifesting as nausea and vomiting such as UTI
3. Type 1 or 2 diabetes
4. Potassium < 3.2 mmol/l
5. Sodium < 130 mmol/l
6. Abnormal liver function tests (associated with increased severity of HG)
7. Abnormal thyroid function tests (associated with increased severity of HG)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Reduction in Pregnancy Unique Emesis Score (PUQE score) at 48 hours
Secondary Outcome Measures
NameTimeMethod
1. Number of days intravenous fluid treatment needed<br>2. Number with ketonuria at 48 hours<br>3. Improvement, at 2 and 7 days from start of treatment, in:<br>3.1. Pregnancy-unique quantification of emesis and nausea (PUQE) score<br>3.2. Drinking and eating scores<br>3.3. Wellbeing rating<br>4. Weight change at 7 days<br>5. Number still taking antiemetics at one week following discharge<br>6. Re-attendance episodes for hyperemesis in the seven days following discharge<br>7. Costs of treatment
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