Clinical trial NCT05698966: Low Dose Antenatal Corticosteroids for Late Preterm Delivery
Official title: Low Dose Antenatal Corticosteroids for Late Preterm Delivery (LoDAC Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Respiratory Morbidity
Preterm Labor
Keywords: corticosteroids
low dose
late prerterm
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2023-01-26
Enrollment: 1510
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Antenatal corticosteroids (ACS) are a type of steroid medication that is administered to pregnant women at risk of preterm birth in order to reduce the risk of respiratory distress syndrome (RDS) and other complications in the newborn. ACS were first demonstrated to be effective in a controlled trial conducted in the 1970s by Liggins and Howie, who used a combination of betamethasone at a dose of 12 mg given in two doses 24 hours apart. Since then, numerous randomized controlled trials and meta-analyses have shown that ACS can significantly reduce neonatal death, RDS, intraventricular hemorrhage, necrotizing enterocolitis, and the need for respiratory support and neonatal intensive care unit admission in preterm infants. ACS are now recommended for use in virtually all pregnancies at risk of preterm delivery between 24 and 34 weeks of gestation. The use of ACS in late preterm pregnancies (between 34 and 37 weeks) has also been studied, with mixed results. The largest study to date, the ALPS trial, found that ACS reduced composite adverse outcomes and respiratory morbidity in late preterm infants, but did not significantly reduce the risk of RDS or mortality. The American Congress of Obstetricians and Gynecologists has recommended the use of ACS in late preterm pregnancies, but with caution due to the potential for adverse effects such as hypoglycemia. Long-term follow-up studies are needed to evaluate the potential long-term effects of ACS in late preterm infants. In this 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: 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

Primary outcomes:
measure: Respiratory morbidity
timeFrame: first 72 hours after birth
Secondary outcomes:
measure: other neonatal morbidities other neonatal morbidities
timeFrame: first 30 days after birth
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Emek Medical Center
city: Ashkelon
country: Israel
facility: Kaplan Medical Center
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center
city: Hadera
country: Israel
facility: Hilel Yafee Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Cmpus
city: Jerusalem
country: Israel
facility: Hadassah Ein Karem
city: Jerusalem
country: Israel
facility: Hadassah Har Hzofim
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Kfar Saba
country: Israel
facility: Meir medical center
city: Nahariya
country: Israel
facility: Galilee Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Zefat
country: Israel
facility: Ziv Medical Center
Study officials:
References: