NCT00187382

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,858

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
4.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

June 15, 2010

Status Verified

June 1, 2010

Enrollment Period

6.2 years

First QC Date

September 13, 2005

Last Update Submit

June 14, 2010

Conditions

Pregnancies at Increased Risk of Preterm Birth

Keywords

antenatal corticosteroidspreterm birthmultiple versus single dosesfollow-up

Outcome Measures

Primary Outcomes (2)

  • MACS: Perinatal or neonatal mortality or serious neonatal morbidity

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

Secondary Outcomes (3)

  • 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)

Interventions

Multiple vs. single courses of antenatalcorticosteroidsDRUG

Eligibility Criteria

Age14 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Toronto, Ontario, M5G 1N8, Canada

Location

Related Publications (4)

  • 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.

    PMID: 25123162DERIVED

  • 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.

    PMID: 24126948DERIVED

  • 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.

    PMID: 22525902DERIVED

  • 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.

    PMID: 20956409DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Kellie Murphy, M.D.

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

April 1, 2001

Primary Completion

June 1, 2007

Study Completion

December 1, 2011

Last Updated

June 15, 2010

Record last verified: 2010-06

Locations

CA(1)