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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 hospitalization

neonatal 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

Page last updated: August 23, 2015

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