Low Dose Antenatal Corticosteroids for Late Preterm Delivery (LoDAC Study)

What this Trial Is About

Researchers are evaluating whether a lower dose of antenatal betamethasone, a steroid medication, is as effective as the standard full dose in preventing respiratory problems in late preterm infants born between 34 and 36 weeks of gestation. This trial focuses on women at high risk for delivering in the late preterm period and aims to determine if a reduced dose can provide similar protection for newborns while potentially reducing side effects. The study is conducted by Rambam Health Care Campus in Israel and builds on previous research showing benefits of antenatal corticosteroids in earlier preterm births. Participants will be randomly assigned to receive either a full dose of 12 mg or a quarter dose of 3 mg of betamethasone. Both groups receive two injections 24 hours apart, with the full dose given as 2 ml and the reduced dose as 0.5 ml per injection. The study compares these two dosing schedules to see if the lower dose prevents respiratory problems and neonatal death within 72 hours after birth as well as the full dose. Additional monitoring will assess other neonatal health issues within 30 days after delivery. During the study, women will be closely monitored from the time of randomization through delivery and the early newborn period. Researchers will track respiratory health and complications in babies during the first 72 hours, as well as other newborn conditions over the first month. The trial includes clinical assessments, and the main outcome focuses on respiratory morbidity in newborns. Participants will be followed until after delivery to evaluate short-term safety and effectiveness of the dosing strategies.

Low Dose Antenatal Corticosteroids for Late Preterm Delivery