Fetal focus: fetal intramuscular steroids for diabetic women at risk of preterm birth

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Background: Administration of corticosteroids prior to birth is of clear benefit to the preterm neonate, with reductions in respiratory, neurological, gastrointestinal, and infectious morbidity, as well as decreased mortality. This benefit was previously proven to exist up to 34 weeks’ gestation but has recently been demonstrated to apply to all neonates born prior to 37 weeks. This benefit is not achieved without potential complications, however, including hyperglycaemia and ketoacidosis in diabetic mothers and neonatal hypoglycaemia. Direct fetal administration of corticosteroids, by ultrasound-guided intramuscular injection may provide the neonatal benefits of steroids while avoiding the maternal and neonatal complications. Objectives: This pilot study aims to assess the feasibility of a larger randomised controlled trial of direct fetal administration versus maternal administration of corticosteroids with the following objectives: a. To assess the effects of directly administered fetal corticosteroids upon maternal glucose homeostasis (hyperglycaemia and ketoacidosis). b. To demonstrate that direct administration of fetal corticosteroids is not associated with adverse fetal/neonatal outcomes including excess preterm birth or neurovascular injuries Trial plan: This pilot randomised controlled trial will recruit 20 pregnant women with pregestational type 1 or type 2 diabetes who are planned for delivery between 34+0 and 36+6 weeks’ gestation and therefore candidates for antenatal corticosteroid administration. Consenting women will be randomised to receive either standard maternal administration of two doses of betamethasone or direct fetal intramuscular injection of a single dose of betamethasone. The primary outcome will be the rate of hyperglycaemia or ketoacidodis requiring treatment. Secondary outcomes will include neonatal rates of respiratory morbidity, hypoglycaemia, and sepsis, and maternal infectious morbidity.

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