Plain English Summary
Not provided at time of registration
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SP3402
Study information
Scientific title
Trial of the effects of antenatal multiple courses of steroids versus a single course (TEAMS): pilot study
Acronym
TEAMS
Study hypothesis
In women judged clinically to be at high risk of preterm delivery the policy of administering more than one course of antenatal corticosteroids does not reduce perinatal death, respiratory distress syndrome and intraventricular haemorrhage in neonates and has a long term adverse effect on later health and development when compared with a single course.
Ethics approval
The protocol was approved by the Multicentre Research Ethics Committee on 8th September 1999 (ref: 98/5/70)
Study design
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
Women at high risk of preterm delivery
Intervention
Women meeting the inclusion criteria and giving informed consent to participate in TEAMS will be randomised to receive either:
1. Two intramuscular injections of betamethasone
2. Placebo 12 - 24 hours apart
The number of courses depends on the risk of preterm delivery.
Intervention type
Drug
Phase
Not Applicable
Drug names
Steroids
Primary outcome measures
1. Neonatal death
2. Neurodevelopmental delay at age 2 years (corrected for gestational age at birth)
Secondary outcome measures
Short term outcomes:
1. Stillbirth
2. Death at any time before discharge from neonatal unit
3. Diagnosis of respiratory distress syndrome
4. Pneumothorax or other pulmonary airleak
5. Intraventricular haemorrhage confirmed by ultrasound
6. Diagnosis of necrotising enterocolitis
7. Chronic lung disease (oxygen dependency at 28 days of life)
8. Neonatal sepsis
9. Birthweight
10. Maternal sepsis
Long term outcomes:
1. Growth delay at age 2 (corrected)
2. Respiratory symptoms at age 2 years (corrected)
3. Sub-scale scores for the Vineland Adaptive Behaviour Scales and Bayley II Scales at age 2 years (corrected)
4. Readmission to hospital
Measures of health service utilisation:
1. Admission to, and duration of stay in, a neonatal intensive care unit
2. Use of, and length of time on, mechanical ventilation
3. Use of surfactant, postnatal corticosteroids, high frequency oscillation, nitric oxide and Extra Corporeal Membrane Oxygenation (ECMO)
Overall trial start date
01/01/2000
Overall trial end date
01/04/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Women who have already received one course of antenatal steroids to improve foetal maturity and:
1. There is clinical uncertainty that a second course of steroids is indicated, and
2. Gestational age is less than 32 weeks
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
600 women in approximately 50 centres
Participant exclusion criteria
Maternal long-term systemic corticosteroid therapy (not including inhaled or topical therapy).
Recruitment start date
01/01/2000
Recruitment end date
01/04/2003
Locations
Countries of recruitment
Italy, United Kingdom
Trial participating centre
Institute of Health Sciences
Oxford
OX3 7LF
United Kingdom
Sponsor information
Organisation
Action Medical Research (UK)
Sponsor details
Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom
Sponsor type
Charity
Website
Funders
Funder type
Charity
Funder name
Action Medical Research (UK)
Alternative name(s)
AMR
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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