Congenital Heart Disease in PregnancyNCT01603732
Association Between a Mother's Exposure to "Strep Throat" and Her Baby's Developing Heart Disease
An observational study of Congenital Heart Disease in Pregnancy, run by Washington University School of Medicine at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease in Pregnancy
- How many people
- 397 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2010to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Random Healthy Controls and Moms with fetal care/echos during pregnancy.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Pregnancy result of fertility treatment including in vitro fertilization
- Emotionally distress
- Mom received blood transfusion or immunoglobin infusion within 6 months of the pregnancy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Cincinatti Children's Hospital Medical Center
Cincinnati, Ohio, 45229
St Louis Childrens Hospital
St Louis, Missouri, 63110
About this study
Official title: Evaluation of Maternal B-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(CHD)
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.
Read the detailed description
The primary objective of this study is to:
- measure maternal ß-hemolytic streptococcal carriage as defined by positive throat cultures in the absence of symptoms among Hypoplastic Left Heart Syndrome (HLHS) mothers.
- define the incidence of positive strep throat cultures among asymptomatic pregnant women, identified at <18 weeks gestation and followed to term.
- Measure antibodies that may cross react to select valvular/myocardial antigens in HLHS/Congenital Heart Defect(CHD)-other neonates born to mothers in the study
- determine serum and/or tissue reactivity against antibodies in matched maternal serum.
The secondary objectives of this study is to:
- measure maternal ß-hemolytic streptococcal serology using standard serology testing among HLHS mothers.
- determine the history of maternal ß-hemolytic streptococcal exposure using a study questionnaire among HLHS mothers.
- Determine "baseline" strep serologies and history of strep exposure among a cohort of asymptomatic pregnant women, identified at <18 weeks gestation and followed to term. The overall purpose of this study is to evaluate the history of β-hemolytic streptococcal pharyngeal exposure, groups A, G and C ("strep throat") in pregnant women whose pregnancies have been complicated by the diagnosis of congenital heart disease. Our short-term goal is to identify a potential association of an antecedent maternal strep throat exposure in pregnancy to identify a subset of heart defects
- To determine if co-infections play a role in congenital heart defects
- Conditions
- Congenital Heart Disease in Pregnancy
- Keywords
- Strep exposure and heart defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
To determine if mothers of babies with HLHS have a significant history of strep infections
Measured: 01/15/2010 - 12/31/2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2012 (estimated)
- Study startJan 2010
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Congenital Heart Disease in PregnancyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Pirooz Eghtesady, MD,PhD, Principal investigator, Washington University School of Medicine and St Louis Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01603732
- Sponsor's protocol ID
- 201102410
- Other IDs
- 5R01HL098634-02
- Status last verified
- Apr 2017
- First submitted
- 18 May 2012
- Last updated
- 4 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16242853McGregor 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.
PubMed 15205431
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Maternal B-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(CHD)
- ClinicalTrials.gov ID
- NCT01603732
- Acronym / sponsor ID
- 201102410
- Conditions
- Congenital Heart Disease in Pregnancy
- Keywords
- Strep exposure and heart defects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jan 2010
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this study is to:
- measure maternal ß-hemolytic streptococcal carriage as defined by positive throat cultures in the absence of symptoms among Hypoplastic Left Heart Syndrome (HLHS) mothers.
- define the incidence of positive strep throat cultures among asymptomatic pregnant women, identified at <18 weeks gestation and followed to term.
- Measure antibodies that may cross react to select valvular/myocardial antigens in HLHS/Congenital Heart Defect(CHD)-other neonates born to mothers in the study
- determine serum and/or tissue reactivity against antibodies in matched maternal serum.
The secondary objectives of this study is to:
- measure maternal ß-hemolytic streptococcal serology using standard serology testing among HLHS mothers.
- determine the history of maternal ß-hemolytic streptococcal exposure using a study questionnaire among HLHS mothers.
- Determine "baseline" strep serologies and history of strep exposure among a cohort of asymptomatic pregnant women, identified at <18 weeks gestation and followed to term. The overall purpose of this study is to evaluate the history of β-hemolytic streptococcal pharyngeal exposure, groups A, G and C ("strep throat") in pregnant women whose pregnancies have been complicated by the diagnosis of congenital heart disease. Our short-term goal is to identify a potential association of an antecedent maternal strep throat exposure in pregnancy to identify a subset of heart defects
- To determine if co-infections play a role in congenital heart defects
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Random Healthy Controls and Moms with fetal care/echos during pregnancy.
Key inclusion criteria (7 listed)
- For Fetal pts:
- HLHS or variant diagnosis
- Other Congenital Heart Disease
- Greater than or = 20wks gestation
- For Healthy moms:
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease
Time frame: 01/15/2010 - 12/31/2014
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).
1 secondary outcome
Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease
Time frame: 01/15/2010 - 12/31/2014
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2017.
- Background: PubMed 16242853Eghtesady 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.
- Background: PubMed 15205431McGregor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pirooz Eghtesady, MD,PhD principal investigator
Washington University School of Medicine and St Louis Children's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease in Pregnancy, run by Washington University School of Medicine at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease (time frame: 01/15/2010 - 12/31/2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01603732, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2017.