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RECRUITING
NCT05698966
NA

Low Dose Antenatal Corticosteroids for Late Preterm Delivery

Sponsor: Rambam Health Care Campus

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

1510

Start Date

2022-01-01

Completion Date

2028-01-01

Last Updated

2024-04-10

Healthy Volunteers

No

Interventions

OTHER

we will use reduced dose of acceptable corticosteroids treatment for preterm birth

the two different group will differ in the doses of corticosteroids

Locations (16)

Emek Medical Center

Afula, Israel

Kaplan Medical Center

Ashkelon, Israel

Soroka Medical Center

Beersheba, Israel

Hilel Yafee Medical Center

Hadera, Israel

Bnai Zion Medical Center

Haifa, Israel

Carmel Medical Center

Haifa, Israel

Rambam Health Care Cmpus

Haifa, Israel

Hadassah Ein Karem

Jerusalem, Israel

Hadassah Har Hzofim

Jerusalem, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Meir medical center

Kfar Saba, Israel

Galilee Medical Center

Nahariya, Israel

Rabin Medical Center

Petah Tikva, Israel

Sheba Medical Center

Ramat Gan, Israel

Ziv Medical Center

Safed, Israel

Sourasky Medical Center

Tel Aviv, Israel