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Management of Nausea and Vomiting of Pregnancy (DIM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00795561
Recruitment Status : Completed
First Posted : November 21, 2008
Last Update Posted : January 15, 2014
Sponsor:
Information provided by (Responsible Party):
Fergus McCarthy, University College Cork

Tracking Information
First Submitted Date  ICMJE November 20, 2008
First Posted Date  ICMJE November 21, 2008
Last Update Posted Date January 15, 2014
Study Start Date  ICMJE April 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
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 Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Management of Nausea and Vomiting of Pregnancy
Official Title  ICMJE 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 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hyperemesis Gravidarum
  • Nausea
  • Vomiting
  • Pregnancy
Intervention  ICMJE
  • Procedure: Day care
    Patients randomised to day care treatment of NVP will be instructed to present to the day services unit where they will receive a pre-agreed fluid and anti emetic regimen.
    Other Names:
    • day unit
    • day services
  • Procedure: Inpatient
    Patients randomised to inpatient management of NVP will be admitted to hospital where they will receive a pre-agreed fluid and anti emetic regimen.
    Other Name: admission
Study Arms  ICMJE
  • Experimental: Day care
    Patients randomised to day care treatment of NVP will be instructed to present to the day services unit where they will receive a pre-agreed fluid and anti emetic regimen.
    Intervention: Procedure: Day care
  • Active Comparator: Inpatient
    Patients randomised to inpatient management of NVP will be admitted to hospital where they will receive a pre-agreed fluid and anti emetic regimen.
    Intervention: Procedure: Inpatient
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 13, 2014)
98
Original Estimated Enrollment  ICMJE
 (submitted: November 20, 2008)
124
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00795561
Other Study ID Numbers  ICMJE ISRCTN05023126
ISRCTN05023126
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fergus McCarthy, University College Cork
Study Sponsor  ICMJE University College Cork
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John R Higgins, MD Cork University Maternity Hospital
PRS Account University College Cork
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP