Low Dose Antenatal Corticosteroids for Late Preterm Delivery

NCT05698966 | Recruiting DMC

• 1 other identifier: 00451890
• Study Type: interventional
• Target: 1,510
• Locations: 1 country
• Sites: 16

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.

Conditions

Respiratory Morbidity; Preterm Labor

Keywords

corticosteroids; low dose; late prerterm

Outcome Measures

Primary Outcomes (1)

• Respiratory morbidity

  1. Use of continuous positive airway pressure (CPAP) or high-flow nasal cannula for ≥2 continuous hr in the first 72 hours 2. Fraction of inspired oxygen of ≥0.30 for ≥4 continuous hr in the first 72 hours 3. Mechanical ventilation in the firdt 72 hours yes/no 4. extracorporeal membrane oxygenation (ECMO) yes/no 5. TTN: transient tachypnea of newborn yes/no

  first 72 hours after birth

Secondary Outcomes (1)

• other neonatal morbidities other neonatal morbidities

  first 30 days after birth

Study Arms (2)

betamethasone 12 mg

ACTIVE COMPARATOR

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

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

betamethasone 3 mg

EXPERIMENTAL

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

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

Interventions

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

the two different group will differ in the doses of corticosteroids

betamethasone 12 mg; betamethasone 3 mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (16)

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

Rambam Health Care Cmpus

Haifa, Israel

RECRUITING

Hadassah Ein Karem

Jerusalem, Israel

RECRUITING

Hadassah Har Hzofim

Jerusalem, Israel

RECRUITING

Shaare Zedek Medical Center

Jerusalem, Israel

RECRUITING

Meir medical center

Kfar Saba, Israel

RECRUITING

Galilee Medical Center

Nahariya, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Sheba Medical Center

Ramat Gan, Israel

RECRUITING

Ziv Medical Center

Safed, Israel

RECRUITING

Sourasky Medical Center

Tel Aviv, Israel

RECRUITING

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Ron Beloosesky, MD

CONTACT

0509205759; tomor2304@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ultrasound in obstetrics and gynecology

Study Record Dates

• First Submitted: December 31, 2022
• First Posted: January 26, 2023
• Study Start: January 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

IL (16)