Actively Recruiting
Low Dose Antenatal Corticosteroids for Late Preterm Delivery
Led by Rambam Health Care Campus · Updated on 2024-04-10
1510
Participants Needed
16
Research Sites
313 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low Dose Antenatal Corticosteroids for Late Preterm Delivery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Singleton pregnancy at 34 weeks 0 days to 36 weeks 5 days of gestation at high risk for late preterm delivery
- Preterm uterine contractions with intact membranes and at least 3 cm cervical dilation or 75% cervical effacement
- Spontaneous rupture of the membranes
- Expected delivery via induction or cesarean between 24 hours and 7 days after planned randomization as determined by obstetric provider
You will not qualify if you...
- Already received a full course of betamethasone
- Expected delivery in less than 12 hours, including ruptured membranes with more than 6 contractions per hour or cervical dilation of 3 cm or more unless oxytocin was withheld for at least 12 hours
- Cervical dilation of 8 cm or more
- Evidence of non-reassuring fetal status requiring immediate delivery
- Prior antenatal corticosteroid treatment
- Current known or suspected infection (viral, bacterial, or other)
- Pre-gestational diabetes mellitus
- Infection requiring antibiotics or hospitalization in the month before study
- Poor understanding of the informed consent language
AI-Screening
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Trial Site Locations
Total: 16 locations
1
Emek Medical Center
Afula, Israel
Actively Recruiting
2
Kaplan Medical Center
Ashkelon, Israel
Actively Recruiting
3
Soroka Medical Center
Beersheba, Israel
Actively Recruiting
4
Hilel Yafee Medical Center
Hadera, Israel
Actively Recruiting
5
Bnai Zion Medical Center
Haifa, Israel
Actively Recruiting
6
Carmel Medical Center
Haifa, Israel
Actively Recruiting
7
Rambam Health Care Cmpus
Haifa, Israel
Actively Recruiting
8
Hadassah Ein Karem
Jerusalem, Israel
Actively Recruiting
9
Hadassah Har Hzofim
Jerusalem, Israel
Actively Recruiting
10
Shaare Zedek Medical Center
Jerusalem, Israel
Actively Recruiting
11
Meir medical center
Kfar Saba, Israel
Actively Recruiting
12
Galilee Medical Center
Nahariya, Israel
Actively Recruiting
13
Rabin Medical Center
Petah Tikva, Israel
Actively Recruiting
14
Sheba Medical Center
Ramat Gan, Israel
Actively Recruiting
15
Ziv Medical Center
Safed, Israel
Actively Recruiting
16
Sourasky Medical Center
Tel Aviv, Israel
Actively Recruiting
Research Team
R
Ron Beloosesky, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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