Low Dose Antenatal Corticosteroids for Late Preterm Delivery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-45
SponsorRambam Health Care Campus
About this trial
This is a study proposal for a clinical trial to evaluate the effectiveness of a reduced dose of antenatal betamethasone (a steroid medication) in preventing respiratory problems in late preterm infants (born between 34 and 36 weeks of gestation). The study will be conducted in medical centers in Israel and will involve women who are at high risk for delivering a late preterm infant. The participants will be randomly assigned to receive either a full dose (12 mg) or a quarter dose (3 mg) of betamethasone, administered 24 hours apart. The main outcome measure of the study will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in the two groups. The study is designed to determine if the reduced dose of betamethasone is non-inferior (i.e., not significantly worse) than the full dose in preventing respiratory problems in late preterm infants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- 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).
Preterm uterine contractions with intact membranes, and at least 3 cm dilation or 75% cervical effacement
Spontaneous rupture of the membranes
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
we will use reduced dose of acceptable corticosteroids treatment for preterm birth
Other interventionthe two different group will differ in the doses of corticosteroids
Treatment groups
1,510 Participants
are divided into 2 treatment groupsGroup A: betamethasone 12 mgActive comparator 1 intervention
Group B: betamethasone 3 mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Respiratory morbidity
1. Use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for ≥2 continuous hr in the first 72 hours 2. Fraction of inspired oxygen of ≥0.30 for ≥4 continuous hr in the first 72 hours 3. Mechanical ventilation in the firdt 72 hours yes/no 4. extracorporeal membrane oxygenation (ECMO) yes/no 5. TTN: transient tachypnea of newborn yes/no
Time frame
first 72 hours after birthSecondary outcomes
1
other neonatal morbidities other neonatal morbidities
for all the parameters: yes or no Severe respiratory complications (a composite outcome of CPAP or high-flow nasal cannula for at least 12 continuous hours, supplemental oxygen with a fraction of inspired oxygen of at least 0.30 for at least at least 24 continuous hours, ECMO or mechanical ventilation, stillbirth, or neonatal death within 72 hours after delivery) Respiratory distress syndrome, Transient tachypnea of the newborn, Apnea, Bronchopulmonary dysplasia, Surfactant administration, Need for resuscitation at birth , Feeding difficulty, Hypothermia, , Necrotizing enterocolitis, Intraventricular hemorrhage Papile grade 3 or 4, Neonatal sepsis, Pneumonia, Pulmonary air leak, Death before discharge Newborns blood levels of glucose: mg/dl insulin and c-peptide : levels in serum
Time frame
first 30 days after birthSponsors and contacts
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Source ClinicalTrials.gov