Schmidt 1984.
Study characteristics | ||
Methods | Parallel, four‐arm RCT. California, USA |
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Participants | Inclusion criteria: preterm labour or having premature rupture of the membranes (or both), gestational age 26 weeks to 32 weeks or estimated fetal weight of 750 g to 1750 g, cervical examination had to be > 5 cm Exclusion criteria: women known to have a disease that might significantly affected by glucocorticosteroids or tocolytic agents or both. If bacteria were seen on Gram stain of amniotic fluid, the woman was excluded. Gestational age: 26 weeks to 32 weeks, or estimated fetal weight of 750 to 1750 g. Number randomised:144 women (149 infants). Numbers randomised to each group are not reported. Numbers analysed: hydrocortisone 15 infants, 15 women; methylprednisolone 17 infants, 16 women; betamethasone 34 infants, 32 women; control 31 infants, 29 women. |
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Interventions | Experimental 1: hydrocortisone 250 mg. Two IM doses, given 24 hours apart. Experimental 2: methylprednisolone 125 mg. Two IM doses, given 24 hours apart. Experimental 3: betamethasone 12 mg. Two IM doses, given 24 hours apart. Control: placebo (saline). Two IM doses, given 24 hours apart. |
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Outcomes | RDS Neonatal death Birth weight |
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Notes | Study dates: July 1977 to April 1980 Study authors’ declarations of interest: not reported Funding sources: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: “the sequence of drugs had been determined by means of a table of random numbers” |
Allocation concealment (selection bias) | Low risk | Quote:“consecutively numbered opaque bags” “the bags were prepared by the project nurses who then sealed them and kept a record of their use” |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote:“the record book was not available to those providing patient care or who were evaluating the data” “each dosage consisted of a 2 ml volume prepared by a nurse on the oncology ward, who had no contact with obstetric patients” “the syringe barrel was covered with an opaque label so the care‐givers could not determine visually which drug was being administered.” |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Outcome assessors seem to be care‐givers, who are blinded. |
Incomplete outcome data (attrition bias) All outcomes | High risk | 52/144 women and their infants excluded from analysis (28 because of birth weights > 2500 g, 13 due to incomplete maternal or baby information, 6 due to procedural errors, 3 due to mature L/S ratio, 2 stillbirths). The group allocation of these women is not reported. |
Selective reporting (reporting bias) | High risk | No protocol, most outcomes reported in full but no data reported for endometritis although it is specified in the methods. |
Other bias | High risk | Quote:“hydrocortisone and methylprednisolone groups discontinued at 24 months to increase group size in remaining two regimens” |