Management of Nausea and Vomiting of Pregnancy

Pregnancy Clinical Trial

— DIM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795561
• Other study ID #: ISRCTN05023126
• Secondary ID: ISRCTN05023126
• Status: Completed
• Phase: N/A
• First received: November 20, 2008
• Last updated: January 13, 2014
• Start date: April 2009
• Est. completion date: September 2012

Study information

• Verified date: January 2014
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Clinical Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hyperemesis Gravidarum
• Nausea
• Pregnancy
• Pregnancy Complications
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
Ireland	Department of Obstetrics and Gynaecology, Cork University Maternity Hospital	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

References & Publications (14)

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. — View 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).

Bailit JL. Hyperemesis gravidarium: Epidemiologic findings from a large cohort. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):811-4. — View Citation

Gadsby R, Barnie-Adshead AM, Jagger C. A prospective study of nausea and vomiting during pregnancy. Br J Gen Pract. 1993 Jun;43(371):245-8. Erratum in: Br J Gen Pract 1993 Aug;43(373):325. — View Citation

Gazmararian JA, Petersen R, Jamieson DJ, Schild L, Adams MM, Deshpande AD, Franks AL. Hospitalizations during pregnancy among managed care enrollees. Obstet Gynecol. 2002 Jul;100(1):94-100. — View Citation

Goodwin TM, Montoro M, Mestman JH. Transient hyperthyroidism and hyperemesis gravidarum: clinical aspects. Am J Obstet Gynecol. 1992 Sep;167(3):648-52. — View Citation

Hod M, Orvieto R, Kaplan B, Friedman S, Ovadia J. Hyperemesis gravidarum. A review. J Reprod Med. 1994 Aug;39(8):605-12. Review. — View Citation

Ismail SK, Kenny L. Review on hyperemesis gravidarum. Best Pract Res Clin Gastroenterol. 2007;21(5):755-69. Review. — View Citation

Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials. Lancet. 2001 Apr 14;357(9263):1191-4. — View Citation

Nelson-Piercy C. Treatment of nausea and vomiting in pregnancy. When should it be treated and what can be safely taken? Drug Saf. 1998 Aug;19(2):155-64. Review. — View Citation

Oates-Whitehead R. Nausea and vomiting in early pregnancy. Clin Evid. 2004 Jun;(11):1840-52. Review. — View Citation

Sheehan P. Hyperemesis gravidarum--assessment and management. Aust Fam Physician. 2007 Sep;36(9):698-701. Review. — View Citation

Verberg MF, Gillott DJ, Al-Fardan N, Grudzinskas JG. Hyperemesis gravidarum, a literature review. Hum Reprod Update. 2005 Sep-Oct;11(5):527-39. Epub 2005 Jul 8. Review. Erratum in: Hum Reprod Update. 2007 Mar-Apr;13(2):207. — View Citation

World Health Organisation, International Statistical Classification of Diseases and Related Health Problems. 10th Revision. Version for 2007.

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		Following discharge	No
Secondary	Total number of hours spent in hospital secondary to NVP from initial presentation until 22 weeks gestation.		22 weeks gestation	No
Secondary	Total amount of intravenous fluids administered secondary to NVP from initial presentation until 22 weeks gestation		22 weeks gestation	No
Secondary	Total amount of anti-emetics administered secondary to NVP from initial presentation until 22 weeks gestation.		22 weeks gestation	No
Secondary	Total Multivitamin complexes administered secondary to NVP from initial presentation until 22 weeks gestation		22 weeks gestation	No
Secondary	Patient satisfaction will be measured by the Client Satisfaction Questionnaire.		Following first presentation	No
Secondary	Incidence of miscarriage		22 weeks gestation	No
Secondary	Infant birth weight at delivery		Following delivery	No
Secondary	Gestational age at delivery.		following delivery	No
Secondary	Total days lost at work secondary to NVP from initial presentation until 22 weeks gestation. (Asked at 16 weeks gestation)		16 weeks gestation	No

External Links

•   Home page of Department of Obstetrics and Gynaecology, University College Cork, Cork University Maternity Hospital.