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| ID | Type | Description | Link |
|---|---|---|---|
| ISRCTN72654148 |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multiple vs. single courses of antenatalcorticosteroids | Drug |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kellie Murphy, M.D. | MOUNT SINAI HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Data Coordinating Centre, CMICR 790 Bay Street, 7th Floor | Toronto | Ontario | M5G 1N8 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25123162 | Derived | Asztalos E, Willan A, Murphy K, Matthews S, Ohlsson A, Saigal S, Armson A, Kelly E, Delisle MF, Gafni A, Lee S, Sananes R, Rovet J, Guselle P, Amankwah K; MACS-5 Collaborative Group. Association between gestational age at birth, antenatal corticosteroids, and outcomes at 5 years: multiple courses of antenatal corticosteroids for preterm birth study at 5 years of age (MACS-5). BMC Pregnancy Childbirth. 2014 Aug 13;14:272. doi: 10.1186/1471-2393-14-272. | |
| 24126948 |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| Derived |
| Asztalos EV, Murphy KE, Willan AR, Matthews SG, Ohlsson A, Saigal S, Armson BA, Kelly EN, Delisle MF, Gafni A, Lee SK, Sananes R, Rovet J, Guselle P, Amankwah K, Saleem M, Sanchez J; MACS-5 Collaborative Group. Multiple courses of antenatal corticosteroids for preterm birth study: outcomes in children at 5 years of age (MACS-5). JAMA Pediatr. 2013 Dec;167(12):1102-10. doi: 10.1001/jamapediatrics.2013.2764. |
| 22525902 | Derived | Murphy KE, Willan AR, Hannah ME, Ohlsson A, Kelly EN, Matthews SG, Saigal S, Asztalos E, Ross S, Delisle MF, Amankwah K, Guselle P, Gafni A, Lee SK, Armson BA; Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study Collaborative Group. Effect of antenatal corticosteroids on fetal growth and gestational age at birth. Obstet Gynecol. 2012 May;119(5):917-23. doi: 10.1097/AOG.0b013e31825189dc. |
| 20956409 | Derived | Asztalos EV, Murphy KE, Hannah ME, Willan AR, Matthews SG, Ohlsson A, Kelly EN, Saigal S, Ross S, Delisle MF, Amankwah K, Guselle P, Gafni A, Lee SK, Armson BA, Sananes R, Tomat L; Multiple Courses of Antenatal Corticosteroids for Preterm Birth Study Collaborative Group. Multiple courses of antenatal corticosteroids for preterm birth study: 2-year outcomes. Pediatrics. 2010 Nov;126(5):e1045-55. doi: 10.1542/peds.2010-0857. Epub 2010 Oct 18. |
| D000091642 | Urogenital Diseases |