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 |
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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 |
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Interventions | The treatment group received 2 doses of 12 mg betamethasone IM, 12 hours apart. The control group received no treatment. |
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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 |
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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. |