Antenatal Corticoid Therapy for Late Preterm Babies
Information source: Instituto Materno Infantil Prof. Fernando Figueira
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyaline Membrane Disease; Transient Tachypnea
Intervention: Betamethasone (Drug)
Phase: N/A
Status: Completed
Sponsored by: Instituto Materno Infantil Prof. Fernando Figueira Official(s) and/or principal investigator(s): Melania Amorim, MD, PhD, Study Director, Affiliation: Instituto Materno Infantil Prof. Fernando Figueira
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.
Clinical Details
Official title: Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Primary outcome: neonatal respiratory distress
Secondary outcome: during of neonatal hospitalizationneonatal oxygen requirement neonatal sepsis neonatal death
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 49 Years.
Gender(s): Female.
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
Locations and Contacts
Instituto Materno Infantil Prof. Fernando Figueira, Recife, Pernambuco 50070550, Brazil
Additional Information
Starting date: May 2008
Last updated: June 8, 2010
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