Clinical trial NCT00795561: Management of Nausea and Vomiting of Pregnancy
Official title: Randomized Controlled Trial of Day Care Versus Inpatient Management of Nausea and Vomiting of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperemesis Gravidarum
Nausea
Vomiting
Pregnancy
Keywords: Hyperemesis gravidarum
nausea
vomiting
pregnancy
day care
inpatient management
Nausea and vomiting of pregnancy
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2008-11-21
Enrollment: 98
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Upto 80% of all pregnant women experience some form of nausea and vomiting (NVP) during their pregnancy. Hyperemesis gravidarum, a more severe form of NVP affects approximately 0.3- 2.0% of pregnancies and is the commonest indication for admission to hospital in the first half of pregnancy and second only to preterm labor as a cause of hospitalization overall. According to the Hyperemesis Education and Research Foundation, conservative estimates indicate that HG can cost a minimum of $200 million annually in house hospitalizations in the United States of America. The investigators aim to conduct a randomized controlled trial to test the hypothesis that the availability of day care services for the initial treatment of NVP reduces the mean duration of stay in hospital by 1 day and results in significantly greater patient satisfaction compared with standard inpatient management.

Detailed description: Upto 80% of all pregnant women experience some form of nausea and vomiting during their pregnancy (NVP). The International Statistical Classification of Disease and Related Health Problems ICD-10 defines hyperemesis gravidarum (HG) as persistent and excessive vomiting starting before the end of the 22nd week of gestation, and further subdivides the condition into mild and severe, severe being associated with metabolic disturbances such as carbohydrate depletion, dehydration or electrolyte imbalance. HG is a diagnosis of exclusion, characterized by prolonged and severe nausea and vomiting, dehydration, large ketonuria and \> 5% bodyweight loss.

HG affects approximately 0.3- 2.0% of pregnancies and is the commonest indication for admission to hospital in the first half of pregnancy and second only to preterm labor as a cause of hospitalisation overall. According to the Hyperemesis Education and Research Foundation, conservative estimates indicate that HG can cost a minimum of $200 million annually in house hospitalizations in the United states. Taking into account other factors such as emergency room treatments, potential complications of severe HG and the fact that up to 35% of women with paid employment will lose time from work through nausea the actual cost of NVP to the economy is significantly higher.

NVP can be extremely debilitating for the patient and if inadequately managed can cause significant morbidities including malnutrition and electrolyte imbalances, thrombosis, Wernicke's encephalopathy, depressive illness and poor pregnancy outcomes such as prematurity and small for gestational age fetuses.

Day care has proven to be beneficial and safe mode of care for patients in other clinical settings. Studies have demonstrated that day care management of patients with NVP appears acceptable and feasible but no systematic reviews or randomized controlled trials have been performed which examine the effects of introducing day care on rates of hospital admission, duration of inpatient stay and patient satisfaction.

We aim to conduct a prospective open label randomized controlled trial to test the hypothesis that the availability of day care services for the initial treatment of NVP reduces the mean duration of stay in hospital by 1 day (28.6%) and results in significantly greater patient satisfaction compared with standard inpatient management.

The null hypothesis states there is no difference in the amount of inpatient hospital days when women with NVP are treated initially in day care or by standard inpatient admission.

All pregnant women under 22 weeks gestation, who have not already been treated for NVP in their current pregnancy, presenting with the diagnosis of NVP are eligible for inclusion in the trial. The treatment group will be day care treatment of NVP. The comparison group will be the inpatient treatment of NVP.

Eligibility criteria: Inclusion Criteria:

Women (no age limits) will be admitted to the study if they have two or more of the following criteria

* Ongoing viable intrauterine pregnancy/ pregnancies \< 22 weeks gestation
* Persistent vomiting (\>x3 episodes/ 24 hours) not attributable to other causes
* Severe nausea not attributable to other causes.
* Dehydration diagnosed by the presence of ketonuria.
* Electrolyte imbalance not attributable to other causes.

Exclusion Criteria:

Women will not be admitted to the study if any of the following criteria are present.

* Women with a confirmed urinary tract infection (mid stream urine isolation of a single strain of uropathogen \>105 bacteria/ml)
* Women with molar pregnancies
* Women with non viable pregnancies.
* Women who have already received treatment for NVP outside of this trial.
* 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.
* Women who do not have a good understanding of English.

Primary outcomes:
measure: The primary outcome will be the 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.
timeFrame: Following discharge
Secondary outcomes:
measure: Total number of hours spent in hospital secondary to NVP from initial presentation until 22 weeks gestation.
timeFrame: 22 weeks gestation
measure: Total amount of intravenous fluids administered secondary to NVP from initial presentation until 22 weeks gestation
timeFrame: 22 weeks gestation
measure: Total amount of anti-emetics administered secondary to NVP from initial presentation until 22 weeks gestation.
timeFrame: 22 weeks gestation
measure: Total Multivitamin complexes administered secondary to NVP from initial presentation until 22 weeks gestation
timeFrame: 22 weeks gestation
measure: Patient satisfaction will be measured by the Client Satisfaction Questionnaire.
timeFrame: Following first presentation
measure: Incidence of miscarriage
timeFrame: 22 weeks gestation
measure: Infant birth weight at delivery
timeFrame: Following delivery
measure: Gestational age at delivery.
timeFrame: following delivery
measure: Total days lost at work secondary to NVP from initial presentation until 22 weeks gestation. (Asked at 16 weeks gestation)
timeFrame: 16 weeks gestation
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Department of Obstetrics and Gynaecology, Cork University Maternity Hospital
Study officials:
affiliation: Cork University Maternity Hospital
name: John R Higgins, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Alalade AO, Khan R, Dawlatly B. Day-case management of hyperemesis gravidarum: Feasibility and clinical efficacy. J Obstet Gynaecol. 2007 May;27(4):363-4. doi: 10.1080/01443610701327396.
citation: Attkisson, C.C., and Greenfield, T. K. (1995). The Client Satisfaction Questionnaire (CSQ) scales and the Service Satisfaction Scale- 30 (SSS-30). In L.I. Sederer & B. Dickey (Eds.) Outcomes assessment in clinical practice. (pp. 120-127) Baltimore, MD: Williams & Wilkins. (SSS-30 is reproduced in Appendix pp. 279-283).
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