NCT00281151

Brief Summary

The purpose of this study is to determine the mechanisms underlying the disparities in asthma and to improve asthma care in pregnant women, a targeted group at high risk for asthma-specific maternal and perinatal complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2002

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

September 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

January 20, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

December 11, 2014

Status Verified

February 1, 2009

Enrollment Period

5.7 years

First QC Date

January 20, 2006

Last Update Submit

December 10, 2014

Conditions

AsthmaLung Diseases

Outcome Measures

Primary Outcomes (1)

  • Asthma related maternal/fetal morbidities and asthma control

    Measured between two and six weeks following delivery

Eligibility Criteria

AgeUp to 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

This study will enroll pregnant women with asthma, children requiring intensive care unit (ICU) admission for asthma, and asthmatics requiring emergency care.

You may qualify if:

  • Pregnant women with asthma
  • Children requiring intensive care unit (ICU) admission for asthma
  • Asthmatics requiring emergency care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meharry Medical School

Nashville, Tennessee, 37208, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (6)

  • Talbot TR, Hartert TV, Mitchel E, Halasa NB, Arbogast PG, Poehling KA, Schaffner W, Craig AS, Griffin MR. Asthma as a risk factor for invasive pneumococcal disease. N Engl J Med. 2005 May 19;352(20):2082-90. doi: 10.1056/NEJMoa044113.

    PMID: 15901861BACKGROUND

  • Whalen U, Griffin MR, Shintani A, Mitchel E, Cruz-Gervis R, Forbes BL, Hartert TV. Smoking rates among pregnant women in Tennessee, 1990-2001. Prev Med. 2006 Sep;43(3):196-9. doi: 10.1016/j.ypmed.2006.04.021. Epub 2006 Jun 15.

    PMID: 16780937BACKGROUND

  • Enriquez R, Wu P, Griffin MR, Gebretsadik T, Shintani A, Mitchel E, Carroll KN, Hartert TV. Cessation of asthma medication in early pregnancy. Am J Obstet Gynecol. 2006 Jul;195(1):149-53. doi: 10.1016/j.ajog.2006.01.065. Epub 2006 May 2.

    PMID: 16631099BACKGROUND

  • Carroll KN, Griffin MR, Gebretsadik T, Shintani A, Mitchel E, Hartert TV. Racial differences in asthma morbidity during pregnancy. Obstet Gynecol. 2005 Jul;106(1):66-72. doi: 10.1097/01.AOG.0000164471.87157.4c.

    PMID: 15994619BACKGROUND

  • Hartert TV, Neuzil KM, Shintani AK, Mitchel EF Jr, Snowden MS, Wood LB, Dittus RS, Griffin MR. Maternal morbidity and perinatal outcomes among pregnant women with respiratory hospitalizations during influenza season. Am J Obstet Gynecol. 2003 Dec;189(6):1705-12. doi: 10.1016/s0002-9378(03)00857-3.

    PMID: 14710102BACKGROUND

  • Venarske DL, Busse WW, Griffin MR, Gebretsadik T, Shintani AK, Minton PA, Peebles RS, Hamilton R, Weisshaar E, Vrtis R, Higgins SB, Hartert TV. The relationship of rhinovirus-associated asthma hospitalizations with inhaled corticosteroids and smoking. J Infect Dis. 2006 Jun 1;193(11):1536-43. doi: 10.1086/503809. Epub 2006 Apr 27.

    PMID: 16652282BACKGROUND

MeSH Terms

Conditions

AsthmaLung Diseases

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • James R. Sheller

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

  • John J. Murray

    Meharry Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine

Study Record Dates

First Submitted

January 20, 2006

First Posted

January 24, 2006

Study Start

September 1, 2002

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

December 11, 2014

Record last verified: 2009-02

Locations

US(2)