Low dose corticosteroids to prevent respiratory issues in late preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of a reduced dose of antenatal betamethasone in preventing respiratory problems in late preterm infants born between 34 and 36 weeks of gestation. Women at high risk for late preterm delivery will be randomly assigned to receive either a full dose or a quarter dose of betamethasone, administered 24 hours apart. The main outcome measure will be the incidence of respiratory problems or neonatal death within 72 hours of delivery in both groups, aiming to determine if the lower dose is non-inferior to the standard dose.

Why it matters

Who can join: the full rules

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

Where it's running

• Emek Medical Center
  Afula, Israel Recruiting
• Kaplan Medical Center
  Ashkelon, Israel Recruiting
• Soroka Medical Center
  Beersheba, Israel Recruiting
• Hilel Yafee Medical Center
  Hadera, Israel Recruiting
• Bnai Zion Medical Center
  Haifa, Israel Recruiting
• Carmel Medical Center
  Haifa, Israel Recruiting

Study contacts

• Study coordinator: Ron Beloosesky, MD
• Email: tomor2304@yahoo.com
• Phone: 0509205759

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.