Antenatal Corticoid Therapy for Late Preterm Babies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-05-31

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.

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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.

Conditions

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Hyaline Membrane Disease Transient Tachypnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A

Antenatal corticoid therapy

Group Type EXPERIMENTAL

Betamethasone

Intervention Type DRUG

IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)

Interventions

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Betamethasone

IM administration of 12mg of betamethasone each 24 hours (total dose=24mg)

Intervention Type DRUG

Other Intervention Names

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CELESTONE SOLUSPAN (MANTECORP)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No