NCT05698966 Low Dose Antenatal Corticosteroids for Late Preterm Delivery
| NCT ID | NCT05698966 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rambam Health Care Campus |
| Condition | Respiratory Morbidity |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,510 participants |
| Start Date | 2022-01-01 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,510 participants in total. It began in 2022-01-01 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05698966 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Respiratory Morbidity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05698966 currently recruiting?
Yes, NCT05698966 is actively recruiting participants. Contact the research team at tomor2304@yahoo.com for enrollment information.
Where is the NCT05698966 trial being conducted?
This trial is being conducted at Afula, Israel, Ashkelon, Israel, Beersheba, Israel, Hadera, Israel and 11 additional locations.
Who is sponsoring the NCT05698966 clinical trial?
NCT05698966 is sponsored by Rambam Health Care Campus. The trial plans to enroll 1,510 participants.