Low Dose Antenatal Corticosteroids for Late Preterm Delivery

NCT ID: NCT05698966

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1510 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2028-01-01

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.

Detailed Description

Antenatal corticosteroids (ACS) are a type of steroid medication that is administered to pregnant women at risk of preterm birth in order to reduce the risk of respiratory distress syndrome (RDS) and other complications in the newborn. ACS were first demonstrated to be effective in a controlled trial conducted in the 1970s by Liggins and Howie, who used a combination of betamethasone at a dose of 12 mg given in two doses 24 hours apart. Since then, numerous randomized controlled trials and meta-analyses have shown that ACS can significantly reduce neonatal death, RDS, intraventricular hemorrhage, necrotizing enterocolitis, and the need for respiratory support and neonatal intensive care unit admission in preterm infants. ACS are now recommended for use in virtually all pregnancies at risk of preterm delivery between 24 and 34 weeks of gestation. The use of ACS in late preterm pregnancies (between 34 and 37 weeks) has also been studied, with mixed results. The largest study to date, the ALPS trial, found that ACS reduced composite adverse outcomes and respiratory morbidity in late preterm infants, but did not significantly reduce the risk of RDS or mortality. The American Congress of Obstetricians and Gynecologists has recommended the use of ACS in late preterm pregnancies, but with caution due to the potential for adverse effects such as hypoglycemia. Long-term follow-up studies are needed to evaluate the potential long-term effects of ACS in late preterm infants. In this 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

the two different group will differ in the doses of corticosteroids

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

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

the two different group will differ in the doses of corticosteroids

Interventions

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

the two different group will differ in the doses of corticosteroids

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rambam Health Care Campus

OTHER

Sponsor Role: lead

Responsible Party

Ron Beloosesky MD

Head of ultrasound in obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emek Medical Center

Afula, , Israel

Site Status: RECRUITING

Kaplan Medical Center

Ashkelon, , Israel

Site Status: RECRUITING

Soroka Medical Center

Beersheba, , Israel

Site Status: RECRUITING

Hilel Yafee Medical Center

Hadera, , Israel

Site Status: RECRUITING

Bnai Zion Medical Center

Haifa, , Israel

Site Status: RECRUITING

Carmel Medical Center

Haifa, , Israel

Site Status: RECRUITING

Rambam Health Care Cmpus

Haifa, , Israel

Site Status: RECRUITING

Hadassah Ein Karem

Jerusalem, , Israel

Site Status: RECRUITING

Hadassah Har Hzofim

Jerusalem, , Israel

Site Status: RECRUITING

Shaare Zedek Medical Center

Jerusalem, , Israel

Site Status: RECRUITING

Meir medical center

Kfar Saba, , Israel

Site Status: RECRUITING

Galilee Medical Center

Nahariya, , Israel

Site Status: RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status: RECRUITING

Sheba Medical Center

Ramat Gan, , Israel

Site Status: RECRUITING

Ziv Medical Center

Safed, , Israel

Site Status: RECRUITING

Sourasky Medical Center

Tel Aviv, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Ron Beloosesky, MD

Role: CONTACT

tomor2304@yahoo.com

0509205759

Facility Contacts

Noa Zafran, MD

Role: primary

Edi Vaisbuch, MD

Role: primary

Noa Aleluya, MD

Role: primary

Rinat Gabbay, MD

Role: primary

Rami Sammour, MD

Role: primary

Nir Kugelman, MD

Role: primary

Doron Cabiri

Role: primary

Lorin Levit Rosen, MD

Role: primary

Sorina Grisaru, MD

Role: primary

Or Elinor, MD

Role: primary

Maya Wolf, MD

Role: primary

Sivan Easton, MD

Role: primary

Yoav Yinon, MD

Role: primary

Yael Sciaky-Tamir, MD

Role: primary

Liran Hirsh

Role: primary

Other Identifiers

00451890

Identifier Type: -

Identifier Source: org_study_id