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. 2020 Dec 25;2020(12):CD004454. doi: 10.1002/14651858.CD004454.pub4

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
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