Contact information
Type
Scientific
Primary contact
Dr Cecilia Bottomley
ORCID ID
Contact details
Academic Department of Obstetrics and Gynaecology
3rd Floor Lanesborough Wing
St George's University of London
Cranmer Terrace
London
SW17 0QT
United Kingdom
ceciliabottomley@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Vomiting is a common symptom of early pregnancy, affecting approximately 52% of women. Hyperemesis gravidarum, or severe protracted vomiting appearing for the first time before the 20th week of pregnancy that is not associated with other coincidental conditions and is of such severity as to require the patients' admission to hospital, affects only 0.3 - 1.5% of pregnancies.
HG is associated with a decrease in ability to perform household activities, decreased interaction with existing children, decreased healthcare involvement and increased time off work. There is no consensus in the management and treatment of HG. The majority of the therapeutic anti-emetic treatment is empirical. Intravenous rehydration, correction of electrolyte imbalance, vitamin supplementation and anti-emetics remain the mainstay of treatment of severe disease.
Women with hyperemesis gravidarum (HG) who have been unable to manage with anti-emetics alone and who need rehydration have conventionally been admitted as inpatients. Rapid rehydration within a gynaecology outpatient setting has potential advantages in terms of healthcare cost and maintaining the woman within her home and family environment. Some hospitals currently operate a policy of outpatient ('day case') intravenous rehydration for HG. To date no randomised studies have been conducted comparing outpatient management for rehydration with conventional inpatient treatment.
The aim of this study is therefore to assess the success of outpatient management versus inpatient management in patients with HG.
Study hypothesis:
Rapid outpatient rehydration is as effective as inpatient admission for the treatment for hyperemesis gravidarum.
Ethics approval
Ethics approval received from the Royal Mardsen Research Ethics Committee on the 24th April 2007 (ref: 07/Q0806/2).
Study design
Multicentre 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
Hyperemesis gravidarum
Intervention
Comparison of conventional inpatient continuous intravenous rehydration for women with HG with daily attendance at the Acute Gynaecology Unit for rehydration over four hours. The same anti-emetic and vitamin supplementation will be given to both groups. Women are randomised by computer generated allocation.
All women will be given a single intravenous dose of cyclizine at first attendance followed by regular buccal prochlorperazine 3 mg (increased to 6 mg if ineffective). In addition, when tolerating oral input, all participants will be given oral thiamine 50 mg three times daily and folic acid 5 mg once daily. A single dose of intravenous ranitidine 50 mg will be administered to women reporting epigastric discomfort, followed by 150 mg orally twice daily. Both groups will receive intravenous fluids. The inpatient group will receive 4 litres normal saline over the first 24 hours followed by 3 litres per 24 hours. The outpatient group will receive 2 litres per day, each administered over 4 hours.
Treatment in both groups will continue until:
1. There is no ketonuria, and
2. The woman is able to tolerate food and drink, and
3. There has been no vomiting for at least 12 hours
For both groups, follow up 7 days after completion of treatment will be carried out by telephone to ascertain whether they are still using anti-emetics and whether they have had any re-admissions.
Updated 21/02/2014: The trial did not start as the clinical fellow left the position and there was no funding to support a further research post at the time.
Intervention type
Drug
Phase
Not Specified
Drug names
Cyclizine, prochlorperazine, thiamine, folic acid, ranitidine
Primary outcome measures
A difference between the two groups in reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at 48 hours.
Secondary outcome measures
A difference between the two groups in:
1. Number of days intravenous fluid treatment needed
2. Number with ketonuria at 48 hours
3. Improvement, at two and seven days from start of treatment, in:
3.1. PUQE
3.2. Drinking and eating scores
3.3. Well-being rating
4. Weight change at seven days
5. Number still taking anti-emetics at one week following discharge
6. Re-attendance episodes for hyperemesis in the seven days following discharge
7. Costs of treatment
Overall trial start date
17/03/2008
Overall trial end date
01/04/2009
Reason abandoned
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
All pregnant women up to 20 weeks gestation referred to the Acute Gynaecology Unit with persistent vomiting and at least 1+ ketonuria.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
100 (50 in each arm of trial)
Participant exclusion criteria
1. Women greater than 20 weeks gestation
2. Women with another medical condition manifesting as nausea and vomiting such as urinary tract infection (UTI)
3. Type 1 or 2 diabetes
4. Potassium less than 3.2 mmol/l
5. Sodium less than 130 mmol/l
6. Abnormal liver function tests (associated with increased severity of HG)
7. Abnormal thyroid function tests (associated with increased severity of HG)
Recruitment start date
17/03/2008
Recruitment end date
01/04/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Department of Obstetrics and Gynaecology
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
St George's Healthcare NHS Trust (UK)
Sponsor details
Blackshaw Road
London
SW17 0RE
United Kingdom
tom.bourne@stgeorges.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
St George's Department of Obstetrics and Gynaecology Discretionary Fund (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
St George's Healthcare NHS Trust (UK) - The Directorate of Women's Health
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