Efficacy of Antenatal Steroids in Reducing Respiratory Morbidities in Late Preterm Infants

Phase 2UnknownNCT01206946

American University of Beirut Medical Center700 enrolled

Overview

The hypothesis of the study is that administration of antenatal steroid to women at high risk of preterm birth after 34 weeks of gestation would reduce the risk of respiratory complications, specifically Respiratory Distress Syndrome (RDS) or Transient Tachypnea of the Newborn (TTN) in late preterm babies.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

700

Conditions

Respiratory Distress Syndrome, Newborn Transient Tachypnea of the Newborn

Interventions

BetamethasoneDRUG

A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)

Normal SalineOTHER

Two doses of 2ml of normal saline given at 24 hourly intervals

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 49 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women between 34 0/7- 36 6/7 weeks of gestation * High risk of preterm birth Exclusion Criteria: * Multiple births * Fetal congenital malformations * A course of steroids within 2 weeks of randomization * Multiple courses of steroids * Chorioamnionitis * Non reassuring fetal heart rate * Obstetrical indication of delivery * Active bleeding * Pregnancy related hypertensive disorders * Uncontrolled diabetes

Locations (5)

American University of Beirut Medical Center

Beirut, Lebanon

RECRUITING

Bahman Hospital

Beirut, Lebanon

RECRUITING

Hotel Dieu de France

Beirut, Lebanon

NOT_YET_RECRUITING