Women at high risk of preterm delivery Pregnancy and Childbirth Pregnancy
Conditions
Interventions
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
Sponsors
Action Medical Research (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: Maternal long-term systemic corticosteroid therapy (not including inhaled or topical therapy).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Neonatal death 2. Neurodevelopmental delay at age 2 years (corrected for gestational age at birth) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Italy, United Kingdom
Outcome results
None listed