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Management of Nausea and Vomiting of Pregnancy

2014-07-24 14:15:11 | BioPortfolio

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.

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.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Hyperemesis Gravidarum

Intervention

Day care, Inpatient

Location

Department of Obstetrics and Gynaecology, Cork University Maternity Hospital
Cork
Ireland

Status

Not yet recruiting

Source

University College Cork

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:15:11-0400

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Hyperemesis Gravidarum and 75 Gram Oral Glucose Tolerance Test

Hyperemesis gravidarum (HEG) is not only nausea and vomiting of pregnancy, but it is also a clinical syndrome including endocrine and metabolic complications. Recently, some investigators ...

Nutritional Markers in Normal and Hyperemesis Pregnancies

This study evaluate the rate of nausea and nutritional status in patients with hyperemesis gravidarum (severe nausea and vomiting in pregnancy) and healthy pregnant women using a questionn...

PubMed Articles [11181 Associated PubMed Articles listed on BioPortfolio]

History of depression and risk of hyperemesis gravidarum: a population-based cohort study.

Hyperemesis gravidarum (HG) is a pregnancy condition characterised by debilitating nausea and vomiting. HG has been associated with depression during pregnancy but the direction of the association rem...

Hyperemesis gravidarum is associated with increased maternal serum ischemia-modified albumin.

Our objective was to measure the circulating levels of ischemia-modified albumin (IMA) among pregnant with hyperemesis gravidarum (HEG) and to compare their levels with age- and body mass index (BMI)-...

Are early pregnancy complications more common in women with hyperemesis gravidarum?

Ultrasound evaluation is usually requested for women presenting with hyperemesis gravidarum (HG) in early pregnancy. This is to check viability as well as to diagnose multiple pregnancies and exclude ...

Inpatient Health Care Utilisation in patients with Alcoholic Liver Disease: What are the costs and outcomes?

Alcoholic liver disease (ALD) carries a significant cost burden, and often leads to inpatient care. It is unclear whether inpatient care for ALD is any more costly than admission for other reasons.

Impact of Massachusetts Health Reform on Inpatient Care Use: Was the Safety-Net Experience Different Than in the Non-Safety-Net?

Most inpatient care for the uninsured and other vulnerable subpopulations occurs in safety-net hospitals. As insurance expansion increases the choice of hospitals for the previously uninsured, we exam...

Medical and Biotech [MESH] Definitions

Intractable VOMITING that develops in early PREGNANCY and persists. This can lead to DEHYDRATION and WEIGHT LOSS.

An interval of care by a health care facility or provider for a specific medical problem or condition. It may be continuous or it may consist of a series of intervals marked by one or more brief separations from care, and can also identify the sequence of care (e.g., emergency, inpatient, outpatient), thus serving as one measure of health care provided.

Symptoms of NAUSEA and VOMITING in pregnant women that usually occur in the morning during the first 2 to 3 months of PREGNANCY. Severe persistent vomiting during pregnancy is called HYPEREMESIS GRAVIDARUM.

Payments that include adjustments to reflect the costs of uncompensated care and higher costs for inpatient care for certain populations receiving mandated services. MEDICARE and MEDICAID include provisions for this type of reimbursement.

Health care services provided to patients on an ambulatory basis, rather than by admission to a hospital or other health care facility. The services may be a part of a hospital, augmenting its inpatient services, or may be provided at a free-standing facility.

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