Antenatal Corticoid Therapy for Late Preterm Babies

Study Overview
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Brief Summary
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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
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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.

Official Title
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Antenatal Corticoid Therapy for Fetal Lung Maturation in Late Preterm Pregnancies: a Randomized Controlled Trial

Conditions
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Hyaline Membrane Disease, Transient Tachypnea

Intervention / Treatment
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* Drug: Betamethasone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Antenatal corticoid therapy | Drug: Betamethasone<br>* IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)<br>* Other names: CELESTONE SOLUSPAN (MANTECORP);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neonatal respiratory distress |  | neonatal period (28 days of life) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| during of neonatal hospitalization |  | neonatal period (28 days of life) | 
| neonatal oxygen requirement |  | neonatal period (28 days of life) | 
| neonatal sepsis |  | neonatal period (28 days of life) | 
| neonatal death |  | neonatal period (28 days of life) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corticoid therapy, fetal lung maturation, late preterm, respiratory distress syndrome, neonatal death