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Completed

NCT Number: NCT00187382

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

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.

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Key information

Conditions

Pregnancies at Increased Risk of Preterm Birth Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

14 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor

Toronto, Ontario, M5G 1N8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Multiple vs. single courses of antenatalcorticosteroids

Drug

Primary outcomes

  1. MACS: Perinatal or neonatal mortality or serious neonatal morbidity

  2. MACS-5: Mortality or survival with severe neuro-morbidities at 5 years of age

Secondary outcomes

  1. MACS: Death or neurologic impairment at 2 years of age

  2. MACS-5: Measures of growth and blood pressure assessed by clinical exam

  3. MACS-5: At Canadian sites, abnormalities in intelligence and specific cognitive skills (WPPSI-III, Beery: VMI and PPVT-III)

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Registry information

Important dates

Study start
2001
Primary completion
2007
Study completion
2011
First posted
Sep 16, 2005
Registry last updated
Jun 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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