Condition category
Pregnancy and Childbirth
Date applied
01/03/2001
Date assigned
01/03/2001
Last edited
11/12/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.npeu.ox.ac.uk/teams/

Contact information

Type

Scientific

Primary contact

Ms Helen Adams

ORCID ID

Contact details

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

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

http://www.action.org.uk/

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

Publication citations

Additional files

Editorial Notes