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Day care versus Inpatient Management of nausea and vomiting of pregnancy - D.I.M. trial

Randomised controlled trial of day care versus inpatient management of nausea and vomiting of pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05023126
Enrollment
124
Registered
2008-11-10
Start date
2009-01-05
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Nausea and vomiting of pregnancy (NVP)/ hyperemesis gravidarum (HG) Pregnancy and Childbirth Excessive vomiting in pregnancy

Interventions

Day care treatment vs inpatient treatment of NVP. Patients will attend Cork University Maternity Hospital for day care or inpatient treatment until resolution of symptoms.

Sponsors

Cork University Maternity Hospital (Ireland)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: All pregnant women under 22 weeks gestation presenting to the emergency department of Cork University Maternity Hospital (CUMH) are candidates for inclusion in the trial. Patients who fulfil the International Classification Disease (ICD-10) definition of hyperemesis gravidarum (mild and severe) will be enrolled in the study. Women (no age limits) will be admitted to the study if they have two or more of the following criteria: 1. Ongoing viable intrauterine pregnancy/ pregnancies 3 episodes/ 24 hours) not attributable to other causes 3. Severe nausea not attributable to other causes 4. Dehydration diagnosed by the presence of ketonuria 5. Electrolyte imbalance not attributable to other causes

Exclusion criteria

Exclusion criteria: Women will not be admitted to the study if any of the following criteria are present: 1. Women with a confirmed urinary tract infection (mid stream urine isolation of a single strain of uropathogen >10^5 bacteria/ml) 2. Women with molar pregnancies 3. Women with non-viable pregnancies 4. Women who have already received treatment for NVP outside of this trial 5. Pregnant women who present who will not be booking at CUMH for their pregnancy or are not resident in the South West of Ireland i.e. day care treatment is not an option 6. Women who do not have a good understanding of English

Design outcomes

Primary

MeasureTime frame
Number of inpatient nights spent in hospital, secondary to NVP from initial presentation until 22 weeks gestation. An inpatient night will be defined as requiring an inpatient bed between the hours of 20.00 and 08.00.

Secondary

MeasureTime frame
1. Total number of hours spent in hospital, secondary to NVP from initial presentation until 22 weeks gestation 2. Total amount of intravenous fluids administered, secondary to NVP from initial presentation until 22 weeks gestation 3. Total amount of anti-emetics administered, secondary to NVP from initial presentation until 22 weeks gestation 4. Total multivitamin complexes administered, secondary to NVP from initial presentation until 22 weeks gestation 5. Patient satisfaction recorded after the first day care/ inpatient treatment. Patient satisfaction will be measured by the Client Satisfaction Questionnaire (CSQ-18B). To avoid bias, this questionnaire will be recorded only once after the first day care/ inpatient treatment. If a participant receives more than one treatment she will not be asked to fill in the questionnaire again. The first presentation for day care/inpatient treatment may range from conception to 22 weeks gestation. 6. Incidence of miscarriage 7. Infant birth weight at delivery 8. Gestational age at delivery 9. Total days lost at work due to NVP, asked at 16 weeks gestation

Countries

Ireland

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 19, 2026