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

Lopez 1989.

Study characteristics
Methods Type of study: RCT
Method of treatment allocation: not described
Stratification: not stated
Placebo: no.
Sample size calculation: not stated
Intention‐to‐treat analyses: not stated however, all those randomised were analysed
Losses to follow‐up: nil
Participants Location: Department of Obstetrics and Gynecology, Faculty of Medicine, National Univeristy of Colombia
Eligibility criteria: PROM (confirmed using speculoscopy and ultrasound), no signs of infection, not in labour at time of hospitalisation
Gestational age range: 27‐35 weeks' gestation
Exclusion criteria: not stated
Total recruited: 20 control group, 20 study group
40 women, 40 infants
Interventions The treatment group received 2 doses of 12 mg betamethasone IM, 12 hours apart.
The control group received no treatment.
Outcomes Neonatal mortality, RDS, Apgar score < 7 at 5 minutes, systemic infection in first 48 hours
Notes Original article in Spanish, translated into English
Study dates: August 1983‐December 1985
Funding: not stated
Declarations of interest: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not stated other than quote: "patients were classified randomly into groups"
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias)
All outcomes High risk Comparison is "no treatment" so blinding not possible
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 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 sources of bias exist.