Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
98 participants
INTERVENTIONAL
2009-04-30
2012-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Management of Nausea and Vomiting in Pregnancy and Hyperemesis Gravidarum: Evaluation of Clinical Practices in Five Maternity Hospitals in Île-de-France
NCT06841029
Ottawa Nutritional Guidelines for Nausea and Vomiting
NCT05370170
Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy
NCT05098067
Anxiety in Relation to Nausea and Vomiting in Pregnancy
NCT06059794
Hyperemesis Gravidarum and 75 Gram Oral Glucose Tolerance Test
NCT02963753
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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 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.
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University College Cork
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Fergus McCarthy
Research Fellow, Specialist Registrar Obstetrics and Gynaecology
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John R Higgins, MD
Role: PRINCIPAL_INVESTIGATOR
Cork University Maternity Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Obstetrics and Gynaecology, Cork University Maternity Hospital
Cork, , Ireland
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
World Health Organisation, International Statistical Classification of Diseases and Related Health Problems. 10th Revision. Version for 2007.
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.
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.
Hod M, Orvieto R, Kaplan B, Friedman S, Ovadia J. Hyperemesis gravidarum. A review. J Reprod Med. 1994 Aug;39(8):605-12.
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.
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.
Sheehan P. Hyperemesis gravidarum--assessment and management. Aust Fam Physician. 2007 Sep;36(9):698-701.
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.
Oates-Whitehead R. Nausea and vomiting in early pregnancy. Clin Evid. 2004 Jun;(11):1840-52. No abstract available.
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.
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).
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.
Related Links
Access external resources that provide additional context or updates about the study.
Home page of Department of Obstetrics and Gynaecology, University College Cork, Cork University Maternity Hospital.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ISRCTN05023126
Identifier Type: -
Identifier Source: secondary_id
ISRCTN05023126
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.