Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)

Study Overview
=================
Brief Summary
-----------------
In women at 26 to 30 weeks gestation and who are risk for threatened early birth, who have not had their baby by 14 or more days after being given a single course of antenatal corticosteroids (ACS), do repeated courses of ACS every 14 days until 33 weeks' gestational age lower the risk of illness or death in babies compared to repeated courses of placebo. Children are assessed at 2 years and 5 years for neurodevelopmental impairment.

Detailed Description
-----------------
In women at 26 to 30 weeks gestation, who are at increased risk for preterm birth and remain undelivered 14 or more days following a single course of antenatal corticosteroids (ACS), are multiple course of ACS every 14 days until 33 weeks effective in reducing the risk of perinatal or neonatal mortality or significant neonatal morbidity, compared to placebo. 18-24 Month Follow-up: Children (18-24 months corrected gestational age) are assessed with the Bayley Scales of Infant Development (Second Edition) to determine neurodevelopmental impairment. 5 Year Follow-up (MACS-5): Children are assessed using the Child Behaviour Checklist (1 1/2 - 5) and the Behaviour Rating Inventory of Executive Function (Preschool version) to determine neurocognitive function.

Official Title
-----------------
Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study (MACS)

Conditions
-----------------
Pregnancies at Increased Risk of Preterm Birth

Intervention / Treatment
-----------------
* Drug: Multiple vs. single courses of antenatalcorticosteroids


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who have previously received one completed course of ACS, at least 14 days ago and continue to be at increased risk of preterm birth Gestational age greater ≥ 26 weeks and gestational age < 31 weeks Exclusion Criteria: Women requiring chronic doses of corticosteroids secondary to medical conditions Women with a contraindication to corticosteroids Women with clinical evidence of chorioamnionitis (temperature ≥ 38°c) Known lethal congenital anomaly (e.g. anencephaly)

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Multiple vs. single courses of antenatalcorticosteroids|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACS: Perinatal or neonatal mortality or serious neonatal morbidity |  |  | 
| MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACS: Death or neurologic impairment at 2 years of age |  |  | 
| MACS-5: Measures of growth and blood pressure assessed by clinical exam |  |  | 
| MACS-5: At Canadian sites, abnormalities in intelligence and specific cognitive skills (WPPSI-III, Beery: VMI and PPVT-III) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
antenatal corticosteroids, preterm birth, multiple versus single doses, follow-up