Low Dose Antenatal Corticosteroids for Late Preterm Delivery (LoDAC)
Respiratory Morbidity, Preterm Labor
About this trial
This is an interventional prevention trial for Respiratory Morbidity focused on measuring corticosteroids, low dose, late prerterm
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: 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. - 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
Sites / Locations
- Emek Medical CenterRecruiting
- Kaplan Medical CenterRecruiting
- Soroka Medical CenterRecruiting
- Hilel Yafee Medical CenterRecruiting
- Bnai Zion Medical CenterRecruiting
- Carmel Medical CenterRecruiting
- Rambam Health Care CmpusRecruiting
- Hadassah Ein KaremRecruiting
- Hadassah Har HzofimRecruiting
- Shaare Zedek Medical CenterRecruiting
- Meir medical centerRecruiting
- Galilee Medical CenterRecruiting
- Rabin Medical CenterRecruiting
- Sheba Medical CenterRecruiting
- Sourasky Medical CenterRecruiting
- Ziv Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
betamethasone 12 mg
betamethasone 3 mg
3 mg betamethasone sodium phosphate and 3 mg betamethasone acetate per milliliter. The first dose of study drug medication will be administered at randomization as 2 ml injection; the next dose of 2 ml will be administered 24 hours later
3 mg betamethasone sodium phosphate and 3 mg betamethasone acetate per milliliter. The first dose of study drug medication will be administered at randomization as 0.5 ml injection; the next dose of 0.5 ml will be administered 24 hours later