Low Dose Antenatal Corticosteroids for Late Preterm Delivery (LoDAC Study)

Status: Recruiting
Location: See all (16) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

⁃ 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.

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Locations
Other Locations
Israel
Emek Medical Center
RECRUITING
Afula
Kaplan Medical Center
RECRUITING
Ashkelon
Soroka Medical Center
RECRUITING
Beersheba
Hilel Yafee Medical Center
RECRUITING
Hadera
Bnai Zion Medical Center
RECRUITING
Haifa
Carmel Medical Center
RECRUITING
Haifa
Rambam Health Care Cmpus
RECRUITING
Haifa
Hadassah Ein Karem
RECRUITING
Jerusalem
Hadassah Har Hzofim
RECRUITING
Jerusalem
Shaare Zedek Medical Center
RECRUITING
Jerusalem
Meir medical center
RECRUITING
Kfar Saba
Galilee Medical Center
RECRUITING
Nahariya
Rabin Medical Center
RECRUITING
Petah Tikva
Sheba Medical Center
RECRUITING
Ramat Gan
Ziv Medical Center
RECRUITING
Safed
Sourasky Medical Center
RECRUITING
Tel Aviv
Contact Information
Primary
Ron Beloosesky, MD
tomor2304@yahoo.com
0509205759
Time Frame
Start Date: 2022-01-01
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 1510
Treatments
Active_comparator: betamethasone 12 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
Experimental: 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 0.5 ml injection; the next dose of 0.5 ml will be administered 24 hours later
Related Therapeutic Areas
Sponsors
Leads: Rambam Health Care Campus

This content was sourced from clinicaltrials.gov

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