Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Betamethasone
- Conditions
- Hyaline Membrane Disease
- Sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- neonatal respiratory distress
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
This study aims to determine the effectiveness of antenatal corticosteroid therapy in late preterm babies. The investigators hypothesis is corticoid accelerates fetal lung maturation even after 34 weeks and reduces risk of respiratory distress syndrome and other neonatal morbidities.
Detailed Description
Late preterm babies have important morbidity when compared with term babies, with oxygen requirement and more days of hospitalization. If antenatal corticosteroid therapy is necessary for fetal lung maturation after 34 weeks, it remains to be established. The systematic review with metanalysis in Cochrane Library includes a small number of late preterm babies and no conclusion about effectiveness of corticoid therapy in this setting could be drawn. Our hypothesis is that antenatal corticosteroid therapy is effective to prevent respiratory disease and morbidity in late preterm babies and this study will be carried out to evaluate this question.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnancy between 34 and 36 weeks
- •Confirmed gestational age (LMP, USG)
- •Alive fetus
- •Imminent risk of preterm delivery
Exclusion Criteria
- •Multiple pregnancy
- •Major fetal malformations
- •Comproved fetal lung maturity
- •Maternal or fetal indication for immediate interruption of pregnancy
- •Maternal hemorrhagic syndromes (placenta previa, abruptio placenta)
- •Chorioamnionitis
- •Chronic use of corticosteroids
- •Previous use of corticosteroids for fetal lung maturation in the current pregnancy
Arms & Interventions
A
Antenatal corticoid therapy
Intervention: Betamethasone
Outcomes
Primary Outcomes
neonatal respiratory distress
Time Frame: neonatal period (28 days of life)
Secondary Outcomes
- neonatal death(neonatal period (28 days of life))
- during of neonatal hospitalization(neonatal period (28 days of life))
- neonatal sepsis(neonatal period (28 days of life))
- neonatal oxygen requirement(neonatal period (28 days of life))