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
Protocol serial number	SP3402
Sponsor	Action Medical Research (UK)
Funder	Action Medical Research (UK)

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 of protocol

Not provided at time of registration

Contact information

Ms Helen Adams
Scientific

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

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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)
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Steroids
Primary outcome measure(s)	1. Neonatal death 2. Neurodevelopmental delay at age 2 years (corrected for gestational age at birth)
Key secondary outcome measure(s)	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)
Completion date	01/04/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	600
Key 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
Key exclusion criteria	Maternal long-term systemic corticosteroid therapy (not including inhaled or topical therapy).
Date of first enrolment	01/01/2000
Date of final enrolment	01/04/2003

Locations

Countries of recruitment

United Kingdom
England
Italy

Study participating centre

Institute of Health Sciences

Oxford
OX3 7LF
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes