Schutte 1980

Methods	Type of study: RCT Method of treatment allocation: method of randomisation not stated. Coded drug ampoules were provided. Randomisation code was only known to pharmacist. Stratification: none stated Placebo: yes, normal saline Sample size calculation: no Intention‐to‐treat analyses: no Losses to follow‐up: yes, 12 (12%) children in the follow‐up study at ages 10‐12 years (4 in the treatment arm and 8 in the control arm) and 21 (21%) adults in the follow‐up study at age 20 years (10 in the treatment arm and 11 in the control arm) Funding: Dutch Foundation for Research on Prevention (Praeventiefonds Project 28‐1145), the Netherlands
Participants	Location: Department of Obstetrics and Gynaecology and Department of Neonatology, Wilhelmina Gasthuis, University of Amsterdam, Amsterdam, the Netherlands. Timeframe: April 1974‐April 1977 Eligibility criteria: women with preterm labour in whom it was possible to delay delivery by at least 12 h Gestational age range: 26‐32 weeks. Exclusion criteria: no contraindications to the use of corticosteroids or orciprenaline (insulin‐treated diabetes, hyperthyroidism, infection, severe hypertension, cardiac disease, marked fetal growth retardation or fetal distress) Total recruited: 101 women and 123 infants; 50 women and 65 infants in the treatment arm and 51 women and 58 infants in the control arm
Interventions	The treatment group received 8 mg betamethasone phosphate and 6 mg betamethasone acetate IM repeated after 24 h. The control group received an identical placebo. All women received orciprenaline infusion and bed‐rest until 32 weeks.
Outcomes	Maternal outcomes (death, chorioamnionitis, maternal infections, fever after trial entry requiring antibiotics, intrapartum fever requiring antibiotics, postnatal fever, admission to ICU, side effects of therapy), fetal/neonatal outcomes (fetal death, neonatal death, RDS, IVH, birthweight, Apgar score < 7), childhood outcomes (weight, height, head circumference, lung function, visual impairment, hearing impairment, intellectual impairment, cerebral palsy, behavioural/learning difficulties) and adulthood outcomes were reported (weight, height, head circumference, blood pressure, intellectual impairment, age at puberty)
Notes	Initial study report included a third arm of women (n = 133) and infants (n = 164) who had been excluded from randomisation because they were: 1. already in labour (n = 80) and could not be prolonged for at least 12 h or were already 33 weeks' gestation, or; 2. (n = 53) contra‐indicated for corticosteroids, or; 3. wrongly excluded (n = 5). These women and infants are not included in the review. Two perinatal deaths in the corticosteroid treatment arm were excluded for: 1. intrauterine fetal death due to solutio placentae, and 2. death due to prolapsed umbilical cord. These deaths have been included in the analyses. Infections in infants are listed in Table 6 of the Schutte 1979 original report. There are deaths associated with these infections, and it is not clear when these infections or deaths occurred, or if they have been included in the reported numbers for neonatal or perinatal deaths.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Method of randomisation not stated
Allocation concealment (selection bias)	Low risk	Coded drug ampoules prepared by pharmacist
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Trial described as double blind, with pharmacist preparing identical treatment and control ampoules
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Staff were blind to treatment group
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	2 perinatal deaths in the corticosteroids group were excluded. Data for infant infections specify additional deaths, and it is unclear whether or not these deaths are counted in the overall total for perinatal deaths. The inclusion of these deaths will not change the overall conclusions of meta‐analysis in favour of corticosteroid use
Selective reporting (reporting bias)	Low risk	Primary outcome of the trial was RDS; this and other important outcomes are reported
Other bias	Unclear risk	We are unclear as to the impact of exclusions on results, especially for the outcome of perinatal deaths.