Gamsu 1989.
| Study characteristics | ||
| Methods | Type of study: RCT Method of treatment allocation: method of randomisation not stated. Stratification: yes, by hospital Placebo: yes, vehicle of betamethasone preparation Sample size calculation: no Intention‐to‐treat analyses: yes Losses to follow‐up: no | |
| Participants | Location: 11 hospitals in the UK Eligibility criteria: women with spontaneous or planned preterm delivery Gestational age range: < 34 weeks Exclusion criteria: contraindication to corticosteroids, contraindications to postponing delivery, diabetes, suspected intrauterine infection Total recruited: 251 women and 268 infants; 126 women and 131 infants in the treatment arm and 125 women and 137 infants in the control arm | |
| Interventions | 6 doses of 4 mg betamethasone phosphate IM 8 hours apart
Control group received 6 doses of placebo All women with spontaneous labour received IV salbutamol |
|
| Outcomes | Fetal/neonatal outcomes reported (fetal death, neonatal death, RDS, IVH, birthweight, systemic infection in the first 48 hours of life) | |
| Notes | Study dates: mid 1975‐February 1978 Funding sources: not reported. Quote: "the compilers would like to acknowledge...Glaxo (Group Research Ltd) for the generous provision of computing facilities and for the supply of betamethasone and placebo and their distribution" Declarations of interest: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method of randomisation not stated |
| Allocation concealment (selection bias) | Unclear risk | Method of allocation concealment not stated |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | It is likely that participants were blinded as placebo was used. Blinding of study personnel was not described other than "double‐blind". |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Blinding of outcome assessors was not stated. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses to follow‐up reported |
| Selective reporting (reporting bias) | Low risk | Study protocol not available, but appears to report on all pre‐specified outcomes |
| Other bias | Low risk | Nothing to indicate any other source of bias |