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Summary: The PRECeDe trial has been developed as an international multicentred randomised, placebo-controlled trial to assess the role of antenatal corticosteroids prior to elective CS between 35+0 and 38+6 weeks in women with gestational or pre-gestational diabetes by leading academics in Australia and New Zealand. In order to evaluate the feasibility of undertaking such an ambitious study, we will first undertake this PRECeDe Pilot Feasibility study to determine the patient and clinician acceptability for the trial as well as to ensure that data collection and outcome measures for the main trial are robust.

Study Question: Are women and their care-givers willing to participate in a randomised clinical trial to evaluate the effectiveness or harms of administering antenatal corticosteroids to women with either pre-gestational or gestational diabetes who plan to give birth by elective CS between 35+0 weeks and 38+6 weeks?

Study Objectives: To evaluate the feasibility of conducting a large multicentred randomized clinical trial to evaluate the maternal and neonatal outcomes of administering antenatal corticosteroids to women with either pre-gestational or gestational diabetes who plan to give birth by elective CS between 35+0 weeks and 38+6 weeks. Specifically, to determine

• Whether participation in the trial is acceptable to women
• Whether participation in the trial is acceptable to care providers
• Whether blinding of the interventional drug and placebo is achievable
• Whether the data collection processes are robust and ensure that all data are appropriately measured and collected
• The time taken by research staff to recruit, and randomise women, and collect relevant clinical outcome data

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