Contact information
Type
Scientific
Primary contact
Prof John R Higgins
ORCID ID
Contact details
Anu Research Centre
Department of Obstetrics and Gynecology
University College Cork
Cork University Maternity Hospital
Wilton
Cork
-
Ireland
J.Higgins@ucc.ie
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00795561
Protocol/serial number
N/A
Study information
Scientific title
Randomised controlled trial of day care versus inpatient management of nausea and vomiting of pregnancy
Acronym
D.I.M. trial
Study hypothesis
Up to 80% of all pregnant women experience some form of nausea and vomiting during their pregnancy. 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, characterised by prolonged and severe nausea and vomiting, dehydration, large ketonuria and >5% bodyweight loss.
We aim to conduct a prospective open label randomised controlled trial to test the hypothesis that the availability of day care services for the initial treatment of nausea and vomiting of pregnancy (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.
Ethics approval
Clinical Research Ethics Committee of the Cork Teaching Hospitals, 03/09/2008, ref: ECM 5 [5] 02/09/09
Study design
Open-label single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Nausea and vomiting of pregnancy (NVP)/ hyperemesis gravidarum (HG)
Intervention
Day care treatment vs inpatient treatment of NVP. Patients will attend Cork University Maternity Hospital for day care or inpatient treatment until resolution of symptoms.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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.
Secondary outcome measures
1. Total number of hours spent in hospital, secondary to NVP from initial presentation until 22 weeks gestation
2. Total amount of intravenous fluids administered, secondary to NVP from initial presentation until 22 weeks gestation
3. Total amount of anti-emetics administered, secondary to NVP from initial presentation until 22 weeks gestation
4. Total multivitamin complexes administered, secondary to NVP from initial presentation until 22 weeks gestation
5. Patient satisfaction recorded after the first day care/ inpatient treatment. Patient satisfaction will be measured by the Client Satisfaction Questionnaire (CSQ-18B). To avoid bias, this questionnaire will be recorded only once after the first day care/ inpatient treatment. If a participant receives more than one treatment she will not be asked to fill in the questionnaire again. The first presentation for day care/inpatient treatment may range from conception to 22 weeks gestation.
6. Incidence of miscarriage
7. Infant birth weight at delivery
8. Gestational age at delivery
9. Total days lost at work due to NVP, asked at 16 weeks gestation
Overall trial start date
05/01/2009
Overall trial end date
01/05/2009
Reason abandoned
Eligibility
Participant inclusion criteria
All pregnant women under 22 weeks gestation presenting to the emergency department of Cork University Maternity Hospital (CUMH) are candidates for inclusion in the trial. Patients who fulfil the International Classification Disease (ICD-10) definition of hyperemesis gravidarum (mild and severe) will be enrolled in the study.
Women (no age limits) will be admitted to the study if they have two or more of the following criteria:
1. Ongoing viable intrauterine pregnancy/ pregnancies <22 weeks gestation
2. Persistent vomiting (>3 episodes/ 24 hours) not attributable to other causes
3. Severe nausea not attributable to other causes
4. Dehydration diagnosed by the presence of ketonuria
5. Electrolyte imbalance not attributable to other causes
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
124
Participant exclusion criteria
Women will not be admitted to the study if any of the following criteria are present:
1. Women with a confirmed urinary tract infection (mid stream urine isolation of a single strain of uropathogen >10^5 bacteria/ml)
2. Women with molar pregnancies
3. Women with non-viable pregnancies
4. Women who have already received treatment for NVP outside of this trial
5. 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
6. Women who do not have a good understanding of English
Recruitment start date
05/01/2009
Recruitment end date
01/05/2009
Locations
Countries of recruitment
Ireland
Trial participating centre
Anu Research Centre
Cork
-
Ireland
Sponsor information
Organisation
Cork University Maternity Hospital (Ireland)
Sponsor details
Wilton
Cork
-
Ireland
+353 (0)21 4920500
obs.gyn@ucc.ie
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Cork University Maternity Hospital (Ireland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25198263
Publication citations
-
Results
McCarthy FP, Murphy A, Khashan AS, McElroy B, Spillane N, Marchocki Z, Sarkar R, Higgins JR, Day Care Compared With Inpatient Management of Nausea and Vomiting of Pregnancy: A Randomized Controlled Trial., Obstet Gynecol, 2014, doi: 10.1097/AOG.0000000000000449.