MULTIPLE COURSES OF ANTENATAL CORTICOSTEROIDS FOR PRETERM BIRTH STUDY (MACS)

Not Applicable

Conditions: -O60
O60

Registration Number: PER-062-04

Lead Sponsor: IVERSIDAD DE TORONTO,

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

• Women who have previously received a full course of antenatal corticosteroids 14-21 days before and who continue to have an increased risk of preterm delivery.
• Gestational age greater than or equal to 25 weeks and less than or equal to 32 full weeks of gestation (gestational age will be determined by the clinician based on menstrual history and 1st trimester ultrasound if one is available).
• All fetuses must be alive at the time of randomization. However, in multiple gestations, if it were believed that any fetus had died before week 13, that fetus will not be considered part of the pregnancy for the purpose of this study,

Exclusion Criteria

• Women who require chronic doses of corticosteroids secondary to specific medical situations (eg: systemic lupus erythematosus, congenital adrenal hyperplasia, and severe asthma)
• Women with contraindication to corticosteroids.
• Women with clinical evidence of chorioamnionitis (temperature 38 ° C).
• Known congenital lethal malformation (eg: anencephaly) in any of the fetuses
• First batch of antenatal corticosteroids received prior to week 23
• Previous participation in the MACS

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:defined as antenatal, or postnatal, death during the first 28 days of life or before hospital discharge, which occurred later.<br>Measure:Perinatal or Neonatal Mortality<br>Timepoints:28 days<br>;<br>Outcome name:defined as one or more of the following cases:<br>1. Respiratory Distress Syndrome<br>2. Bronchopulmonary dysplasia<br>3. Grade IV intraventricular hemorrhage<br>4. Periventricular cysts<br>5. Necrotizing enterocolitis<br>Measure:Significant Neonatal Morbidity<br>Timepoints:24 hours<br>

Secondary Outcome Measures