Day care versus Inpatient Management of nausea and vomiting of pregnancy - D.I.M. trial
| ISRCTN | ISRCTN05023126 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05023126 |
| ClinicalTrials.gov number | NCT00795561 |
| Secondary identifying numbers | N/A |
- Submission date
- 03/11/2008
- Registration date
- 10/11/2008
- Last edited
- 10/09/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof John R Higgins
Scientific
Scientific
Anu Research Centre
Department of Obstetrics and Gynecology
University College Cork
Cork University Maternity Hospital
Wilton
Cork
-
Ireland
| J.Higgins@ucc.ie |
Study information
| Study design | Open-label single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Randomised controlled trial of day care versus inpatient management of nausea and vomiting of pregnancy |
| Study acronym | D.I.M. trial |
| Study objectives | 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(s) | Clinical Research Ethics Committee of the Cork Teaching Hospitals, 03/09/2008, ref: ECM 5 [5] 02/09/09 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 05/01/2009 |
| Completion date | 01/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 124 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/01/2009 |
| Date of final enrolment | 01/05/2009 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Anu Research Centre
Cork
-
Ireland
-
Ireland
Sponsor information
Cork University Maternity Hospital (Ireland)
Hospital/treatment centre
Hospital/treatment centre
Wilton
Cork
-
Ireland
| Phone | +353 (0)21 4920500 |
|---|---|
| obs.gyn@ucc.ie | |
| Website | http://www.ucc.ie/en/obsgyn |
"ROR" |
https://ror.org/04q107642 |
Funders
Funder type
Hospital/treatment centre
Cork University Maternity Hospital (Ireland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/10/2014 | Yes | No |
