Management of Nausea and Vomiting of Pregnancy

NCT00795561 | Completed DMC

• 1 other identifier: ISRCTN05023126
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemesis Gravidarum; Nausea; Vomiting; Pregnancy

Keywords

Hyperemesis gravidarum; nausea; vomiting; pregnancy; day care; inpatient management; Nausea and vomiting of pregnancy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Total number of hours spent in hospital 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

• Total amount of anti-emetics administered secondary to NVP from initial presentation until 22 weeks gestation.

  22 weeks gestation

• Total Multivitamin complexes administered secondary to NVP from initial presentation until 22 weeks gestation

  22 weeks gestation

• Patient satisfaction will be measured by the Client Satisfaction Questionnaire.

  Following first presentation

Study Arms (2)

Day care

EXPERIMENTAL

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.

Procedure: Day care

Inpatient

ACTIVE COMPARATOR

Patients randomised to inpatient management of NVP will be admitted to hospital where they will receive a pre-agreed fluid and anti emetic regimen.

Procedure: Inpatient

Interventions

Day care PROCEDURE

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.

Also known as: day unit, day services

Day care

Inpatient PROCEDURE

Patients randomised to inpatient management of NVP will be admitted to hospital where they will receive a pre-agreed fluid and anti emetic regimen.

Also known as: admission

Inpatient

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

Department of Obstetrics and Gynaecology, Cork University Maternity Hospital

Cork, Ireland

Location

Related Publications (14)

• 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. doi: 10.1016/s0029-7844(02)02024-0.

  PMID: 12100809 BACKGROUND

• 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.

  PMID: 8373648 BACKGROUND

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

  BACKGROUND

• 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. doi: 10.2165/00002018-199819020-00006.

  PMID: 9704251 BACKGROUND

• Goodwin TM, Montoro M, Mestman JH. Transient hyperthyroidism and hyperemesis gravidarum: clinical aspects. Am J Obstet Gynecol. 1992 Sep;167(3):648-52. doi: 10.1016/s0002-9378(11)91565-8.

  PMID: 1382389 BACKGROUND

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

  PMID: 7996524 BACKGROUND

• Bailit JL. Hyperemesis gravidarium: Epidemiologic findings from a large cohort. Am J Obstet Gynecol. 2005 Sep;193(3 Pt 1):811-4. doi: 10.1016/j.ajog.2005.02.132.

  PMID: 16150279 BACKGROUND

• Ismail SK, Kenny L. Review on hyperemesis gravidarum. Best Pract Res Clin Gastroenterol. 2007;21(5):755-69. doi: 10.1016/j.bpg.2007.05.008.

  PMID: 17889806 BACKGROUND

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

  PMID: 17885701 BACKGROUND

• Verberg MF, Gillott DJ, Al-Fardan N, Grudzinskas JG. Hyperemesis gravidarum, a literature review. Hum Reprod Update. 2005 Sep-Oct;11(5):527-39. doi: 10.1093/humupd/dmi021. Epub 2005 Jul 8.

  PMID: 16006438 BACKGROUND

• Oates-Whitehead R. Nausea and vomiting in early pregnancy. Clin Evid. 2004 Jun;(11):1840-52. No abstract available.

  PMID: 15652084 BACKGROUND

• 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. doi: 10.1080/01443610701327396.

  PMID: 17654186 BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 11323066 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Hyperemesis Gravidarum; Nausea; Vomiting

Interventions

Day Care, Medical; Inosine Monophosphate; Patient Admission

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Hospitalization

Study Officials

• John R Higgins, MD

  Cork University Maternity Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Fellow, Specialist Registrar Obstetrics and Gynaecology

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: April 1, 2009
• Primary Completion: September 1, 2012
• Study Completion: September 1, 2012
• Last Updated: January 15, 2014

Record last verified: 2014-01

Locations

IE (1)