Evaluation of Maternal B-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(CHD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 397
- 试验地点
- 2
- 主要终点
- Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease
研究概览
简要总结
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.
详细描述
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 4. To determine if co-infections play a role in congenital heart defects
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease
时间窗: 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).
次要结局
- Title: Evaluation of Maternal ß-hemolytic Streptococcal Pharyngeal Exposure in Pregnancies Affected by Congenital Heart Disease(01/15/2010 - 12/31/2014)