Antenatal Corticoid Therapy for Late Preterm Babies (ACTLPT)

Instituto Materno Infantil Prof. Fernando Figueira

Status

Completed

Conditions

Hyaline Membrane Disease

Transient Tachypnea

Treatments

Drug: Betamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT00675246

CORTICOID001

Details and patient eligibility

About

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.

Full 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.

Enrollment

320 estimated patients

Sex

Female

Ages

18 to 49 years old

Volunteers

No Healthy Volunteers

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