Garite 1992.
Study characteristics | ||
Methods | Type of study: RCT Method of treatment allocation: random‐number table generated randomisation sequence by pharmacy. The pharmacy provided consecutive sealed envelopes. Stratification: none stated Placebo: yes, normal saline Sample size calculation: no Intention‐to‐treat analyses: no Losses to follow‐up: yes, 5 (7%) women delivered elsewhere and were lost to follow‐up (4 in treatment arm and 1 in control arm) | |
Participants | Location: Long Beach Memorial Women's Hospital, California, USA Eligibility criteria: women likely to deliver between 24 hours and 7 days with spontaneous preterm labour or planned preterm delivery Gestational age range: 24‐27 + 6 weeks Exclusion criteria: PROM, clinical or laboratory evidence of infection, contraindication to or previously given corticosteroids, diabetes Total recruited: 76 women and 82 infants; 37 women and 40 infants in the treatment arm and 39 women and 42 infants in the control arm | |
Interventions | 2 doses of 6 mg betamethasone acetate and 6 mg betamethasone phosphate IM 24 hours apart, repeated weekly if still < 28 weeks and thought likely to deliver within the next week Control group received 2 doses of placebo. Women undelivered after 28 weeks and 1 week post their last dose of study medication were allowed glucocorticoids at the discretion of their physicians. | |
Outcomes | Maternal outcomes (chorioamnionitis, endometritis), fetal/neonatal outcomes reported (fetal death, neonatal death, RDS, chronic lung disease, IVH, birthweight, Apgar < 7, need for mechanical ventilation/CPAP, duration of mechanical ventilation/CPAP, proven neonatal infection while in NICU) | |
Notes | It is not stated how many women received corticosteroids off protocol. Study dates: December 1984‐May 1990 Funding sources: quote: "supported by a grant from the Long Beach Memorial Foundation" Declarations of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random‐number table generated randomisation sequence by pharmacy |
Allocation concealment (selection bias) | Unclear risk | The pharmacy provided consecutive sealed envelopes, not stated if envelopes were opaque |
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 described. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 5 (7%) women delivered elsewhere and were lost to follow‐up (4 in treatment arm and 1 in control arm). |
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 |