Randomized Controlled Trial of Day Care Versus Inpatient Management of Nausea and Vomiting of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: Following discharge
次要结局
- Patient satisfaction will be measured by the Client Satisfaction Questionnaire.(Following first presentation)
- Incidence of miscarriage(22 weeks gestation)
- Total Multivitamin complexes administered secondary to NVP from initial presentation until 22 weeks gestation(22 weeks gestation)
- Total days lost at work secondary to NVP from initial presentation until 22 weeks gestation. (Asked at 16 weeks gestation)(16 weeks gestation)
- Total number of hours spent in hospital secondary to NVP from initial presentation until 22 weeks gestation.(22 weeks gestation)
- Gestational age at delivery.(following delivery)
- Total amount of anti-emetics administered secondary to NVP from initial presentation until 22 weeks gestation.(22 weeks gestation)
- Total amount of intravenous fluids administered secondary to NVP from initial presentation until 22 weeks gestation(22 weeks gestation)
- Infant birth weight at delivery(Following delivery)
研究者
Fergus McCarthy
Research Fellow, Specialist Registrar Obstetrics and Gynaecology
University College Cork