Stutchfield 2005.
| Study characteristics | ||
| Methods | Parallel randomised control trial | |
| Participants | Location: 10 hospitals in the UK Timeframe: February 1995 to December 2002 Eligibility: women with a singleton pregnancy undergoing a planned elective cesarean section at or after 37 weeks' gestation Exclusion: women with severe maternal hypertension, history of peptic ulceration, severe fetus rhesus sensitisation and evidence of intrauterine infection were excluded Number randomised: 998 (A 503, B 495) Number analysed: 942 (A 467, B 475) Stutchfield 2013: follow‐up of participants (now aged 8‐15 years) from the 4 largest recruiting centres from the original trial |
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| Interventions | Intervention (n = 503): 2 doses of 12 mg of betamethasone administered intramuscularly 24 hours apart, 48 hours before delivery Control (n = 495): treatment as usual (without antenatal corticosteroids) |
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| Outcomes | Primary outcome: admission to special care baby unit with respiratory distress Secondary outcomes
Stutchfield 2013: assessment of long‐term behavioural, cognitive or developmental outcome, and the risk of asthma or atopic disease using questionnaires and general health and school performance |
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| Notes | Funding source of study: "This study was partially funded by the North Wales Small Grant Committee and Welsh Children and Young People’s Research Network (CYPRN)." Declarations of interest: "All authors have the support of Betsi Cadwaladr University Health Board for the submitted work but no other competing interest." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Allocation through a random number generator in MS Excel at the trial centre |
| Allocation concealment (selection bias) | Low risk | The list of treatment allocation (centrally kept) was concealed from all participants. |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Personnel were not blinded to the participants group allocation potentially influencing outcomes. Participants were not blinded to their group allocation, which could impact on maternal outcomes reported but is unlikely to influence other outcomes. Stutchfield 2013: unclear risk of bias as no comment on whether professionals (teachers) were aware of treatment allocation. Participants (mothers) were aware of group allocation, which could influence the outcome (survey response). |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Outcome assessors were not blinded to the participants' group allocation, potentially influencing outcomes. Participants were not blinded to their group allocation, which could impact on maternal outcomes reported but is unlikely to influence other outcomes. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Rate of loss between allocation and delivery: 7% in treatment group and 4% in controls; total losses or deviations from protocol 17%, described in detail by authors |
| Selective reporting (reporting bias) | Unclear risk | Primary and secondary outcomes were prespecified. However, no maternal outcomes were included and adverse maternal outcomes/events were reported. Additional outcomes were reported including: Apgar scores at 1 and 5 minutes, time in special care, time on oxygen and maximum inspired oxygen. |
| Other bias | Low risk | Nothing to indicate any other source of bias |
ACS: antenatal corticosteroids IM: intramuscular NICU: neonatal intensive care unit PPROM: preterm prelabour rupture of the membranes RDS: respiratory distress syndrome TTN: tachypnoea of the newborn