Condition category
Pregnancy and Childbirth
Date applied
03/11/2008
Date assigned
10/11/2008
Last edited
10/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.ucc.ie/en/obsgyn

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

  1. 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.

Additional files

Editorial Notes