Trial of the effects of antenatal multiple courses of steroids versus a single course (TEAMS): pilot study

ISRCTN	ISRCTN46614711
DOI	https://doi.org/10.1186/ISRCTN46614711
Secondary identifying numbers	SP3402

Submission date: 01/03/2001
Registration date: 01/03/2001
Last edited: 11/12/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English Summary

Not provided at time of registration

Study website

Contact information

Ms Helen Adams
Scientific

TEAMS Administrator
NPEU
Institute of Health Sciences
Old Road
Headington
Oxford
OX3 7LF
United Kingdom

Study information

Study design	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	Trial of the effects of antenatal multiple courses of steroids versus a single course (TEAMS): pilot study
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(s)	The protocol was approved by the Multicentre Research Ethics Committee on 8th September 1999 (ref: 98/5/70)
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
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Steroids
Primary outcome measure	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 study start date	01/01/2000
Overall study end date	01/04/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	600 women in approximately 50 centres
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 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

England
Italy
United Kingdom

Study participating centre

Institute of Health Sciences

Oxford
OX3 7LF
United Kingdom

Sponsor information

Action Medical Research (UK)
Charity

Vincent House
Horsham West Sussex
RH12 2DP
United Kingdom

Website	http://www.action.org.uk/
"ROR"	https://ror.org/01wcqa315

Funders

Funder type

Charity

Action Medical Research (UK)
Private sector organisation / Trusts, charities, foundations (both public and private)

Alternative name(s): actionmedres, action medical research for children, AMR
Location: United Kingdom

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