Low Dose Antenatal Corticosteroids for Late Preterm Delivery

Launched by RAMBAM HEALTH CARE CAMPUS · Jan 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a lower dose of a medication called betamethasone, which is a type of steroid, to help prevent breathing problems in babies born a little early, specifically between 34 and 36 weeks of pregnancy. The trial will take place in medical centers in Israel and will involve pregnant women who are at high risk of delivering during this late preterm period. Participants will be randomly assigned to receive either a full dose (12 mg) or a smaller dose (3 mg) of betamethasone, with the goal of seeing if the lower dose is just as effective as the full dose in protecting the babies' health.

To be eligible for the study, women must be pregnant with only one baby and at risk of delivering late preterm. This could be due to certain conditions like having contractions, a ruptured water bag, or being scheduled for an early delivery for medical reasons. However, women who have already received a full course of betamethasone or have certain medical issues may not qualify. Participants can expect to receive the assigned medication and will be monitored for any breathing issues or other serious health problems in their newborns within 72 hours after delivery. This trial aims to provide valuable information that could improve care for late preterm infants.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria:- - Singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation at risk for / high probability of delivery in the late preterm period (34+0-36+5 weeks of gestation).
• Criteria for determination of late preterm delivery risk:
• • 1. Preterm uterine contractions with intact membranes, and at least 3 cm dilation or 75% cervical effacement
• • 2. Spontaneous rupture of the membranes
• • 3. Expected preterm delivery for any other indication via induction or cesarean between 24 hours to 7 days after the planned randomization, as determined by the obstetric provider.
• • -
• • Exclusion Criteria: They had already received a full course of betamethasone.
• • Expected delivery in less than 12 hours, irrespective of cause including: 1)ruptured membranes in the presence of more than 6 contractions per hour or cervical dilation of 3 centimeters or more unless oxytocin was withheld for at least 12 hours (although other induction agents were allowed), 2) chorioamnionitis, 3) cervical dilation of 8 cm or more, and 4) evidence of non-reassuring fetal status requiring immediate delivery.
• • Prior ACS treatment
• • Current known or suspected infection ( viral, bacterial or other)
• • Pre-gestational diabetes mellitus.
• • Any infection that required antibiotics or hospitalization in the month prior to study allocation - Poor understanding of the inform consent language