Clinical Trial: Management of Nausea and Vomiting of Pregnancy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomized Controlled Trial of Day Care Versus Inpatient Management of Nausea and Vomiting of Pregnancy

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 Summary:

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
Sponsor: University College Cork

Current Primary Outcome: 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. [ Time Frame: Following discharge ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Total number of hours spent in hospital secondary to NVP from initial presentation until 22 weeks gestation. [ Time Frame: 22 weeks gestation ]
  • Total amount of intravenous fluids administered secondary to NVP from initial presentation until 22 weeks gestation [ Time Frame: 22 weeks gestation ]
  • Total amount of anti-emetics administered secondary to NVP from initial presentation until 22 weeks gestation. [ Time Frame: 22 weeks gestation ]
  • Total Multivitamin complexes administered secondary to NVP from initial presentation until 22 weeks gestation [ Time Frame: 22 weeks gestation ]
  • Patient satisfaction will be measured by the Client Satisfaction Questionnaire. [ Time Frame: Following first presentation ]
  • Incidence of miscarriage [ Time Frame: 22 weeks gestation ]
  • Infant birth weight at delivery [ Time Frame: Following delivery ]
  • Gestational age at delivery. [ Time Frame: following delivery ]
  • Total days lost at work secondary to NVP from initial presentation until 22 weeks gestation. (Asked at 16 weeks gestation) [ Time Frame: 16 weeks gestation ]


Original Secondary Outcome: Same as current

Information By: University College Cork

Dates:
Date Received: November 20, 2008
Date Started: April 2009
Date Completion:
Last Updated: January 13, 2014
Last Verified: January 2014