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

Randomised trial of rapid outpatient rehydration versus hospital admission for management of hyperemesis gravidarum

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN24659467
Enrollment
120
Registered
2014-04-04
Start date
2014-03-01
Completion date
Unknown
Last updated
2018-03-19

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

Conditions

Hyperemesis gravidarum (severe nausea and vomiting of pregnancy) Pregnancy and Childbirth

Interventions

Outpatient management: Rapid outpatient rehydration Inpatient management: Standard care Women will be recruited and randomised to either inpatient or outpatient management. Both groups will be manag
PUQE score (a validated scoring system used to assess symptoms of nausea and vomiting in pregnancy), eating and drinking score, wellbeing score, weight and blood test results. Treatment will continue

Sponsors

Chelsea and Westminster NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Reduction in Pregnancy Unique Emesis Score (PUQE score) at 48 hours

Secondary

MeasureTime frame
1. Number of days intravenous fluid treatment needed 2. Number with ketonuria at 48 hours 3. Improvement, at 2 and 7 days from start of treatment, in: 3.1. Pregnancy-unique quantification of emesis and nausea (PUQE) score 3.2. Drinking and eating scores 3.3. Wellbeing rating 4. Weight change at 7 days 5. Number still taking antiemetics at one week following discharge 6. Re-attendance episodes for hyperemesis in the seven days following discharge 7. Costs of treatment

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 25, 2026