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 of protocol
Not provided at time of registration
Contact information
Ms Helen Adams
Scientific
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 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 |
| 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 |
| Completion date | 01/04/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 600 women in approximately 50 centres |
| 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
- England
- Italy
- United Kingdom
Study participating centre
Institute of Health Sciences
Oxford
OX3 7LF
United Kingdom
OX3 7LF
United Kingdom
Sponsor information
Action Medical Research (UK)
Charity
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)
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 |
