NCT01603732

Brief Summary

The goal of this study is to find out if there is any association between a mother's exposure to bacteria that normally causes "strep throat" and her baby's developing heart disease/heart defect.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
397

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

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

January 1, 2010

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 4, 2017

Status Verified

April 1, 2017

Enrollment Period

5.9 years

First QC Date

May 18, 2012

Last Update Submit

April 3, 2017

Conditions

Congenital Heart Disease in Pregnancy

Keywords

Strep exposure and heart defects

Outcome Measures

Primary Outcomes (1)

  • Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease

    History of strep infection using a detailed questionnaire and maternal medical records (primary end-point) and (b) maternal titers of the anti-strep antibody, anti-streptolysin O (ASO) (secondary endpoint).

    01/15/2010 - 12/31/2014

Secondary Outcomes (1)

  • Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease

    01/15/2010 - 12/31/2014

Study Arms (4)

Moms w HLHS or variant

Mom's fetal diagnosis Hypoplastic Left Heart Syndrome/variant

Moms w/ Other congential heart defect)

Moms fetal diagnosis -other congenital heart defects

Moms-fetal - echo normal

Moms echo fetal diagnosis is normal.

Random Healthy Moms

Mom with healthy pregnancy.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Random Healthy Controls and Moms with fetal care/echos during pregnancy.

You may qualify if:

  • For Fetal pts:
  • HLHS or variant diagnosis
  • Other Congenital Heart Disease
  • Greater than or = 20wks gestation
  • For Healthy moms:
  • No diagnosis of Congenital Heart Disease
  • Greater than or = 20wks gestation

You may not qualify if:

  • For fetal pts \& healthy controls:
  • Mom less than 18 years old
  • Twins or multiple gestations
  • Pregnancy affected by 2 or more congenital anomalies( in addition to heart defects)
  • Pregnancy affected by OB complications like pre-eclampsia
  • Known history of chromosomal anomaly or carrier status
  • Pregnancy result of fertility treatment including in vitro fertilization
  • Emotionally distress
  • Mom received blood transfusion or immunoglobin infusion within 6 months of the pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

St Louis Childrens Hospital

St Louis, Missouri, 63110, United States

Location

Cincinatti Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Related Publications (2)

  • Eghtesady P. Hypoplastic left heart syndrome: Rheumatic heart disease of the fetus? Med Hypotheses. 2006;66(3):554-65. doi: 10.1016/j.mehy.2005.09.013. Epub 2005 Oct 20.

    PMID: 16242853BACKGROUND

  • McGregor KF, Spratt BG, Kalia A, Bennett A, Bilek N, Beall B, Bessen DE. Multilocus sequence typing of Streptococcus pyogenes representing most known emm types and distinctions among subpopulation genetic structures. J Bacteriol. 2004 Jul;186(13):4285-94. doi: 10.1128/JB.186.13.4285-4294.2004.

    PMID: 15205431BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Confirmation of maternal ß-hemolytic streptococcal \& enterovirus infection(s) will be determined from nose and rectal swabs \& blood samples assayed for standard marker antibodies to ß-hemolytic streptococcal \& enterovirus exposure.

Study Officials

  • Pirooz Eghtesady, MD,PhD

    Washington University School of Medicine and St Louis Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2012

First Posted

May 23, 2012

Study Start

January 1, 2010

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 4, 2017

Record last verified: 2017-04

Locations

US(2)