Fetal Early Non-invasive Biomarkers of Chronic Maternal Stress During Pregnancy Resulting in Alterations of Infant Cognitive Development
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- methylation levels by Epigenome-Wide Association Study (EWAS)
研究概览
简要总结
The investigators´ main hypothesis is that prenatal stress (PS)- induced programming during fetal and postnatal development is reflected in epigenetic and autonomic nervous system (ANS) biomarkers which can be harnessed for early detection and follow-up of affected children. By integrating multiple non-invasively obtainable sources of information using novel epigenetic, electrophysiologic and statistical approaches, the trial could yield progress in maternal-fetal medicine, offering a more precise and truly personalized prediction and new possibilities for designing interventions to improve neurodevelopmental outcomes of pregnancy affected by PS.
详细描述
Rationale:
A cohort of the population of women attending the center of perinatology at the Department of Obstetrics and Gynecology at the Klinikum rechts der Isar of the Technische Universität München (TUM) for having birth will fall in the group of persons with higher perceived stress levels that might concomitantly carry fetuses that show altered sympathetic and vagal activity.
Experimental design:
This study will be conducted at the Department of Obstetrics and Gynecology at the Klinikum rechts der Isar of the Technische Universität München (TUM) a tertiary center of Perinatology of high complexity located in Munich, Germany and that serves about 2000 mothers/newborns per year. TUM obstetricians will identify prospective subjects according with the inclusion criteria of the study, consistent on singleton pregnant women between 18 to 45 years of age in their third trimester (at least 28 weeks gestation) and without a) serious placental alterations; b) fetal malformations; c) maternal severe illness during pregnancy (i.e. preclampsia), d) maternal drug or alcohol abuse, e) preterm birth (less than 37 weeks) and f) Cord blood pH<7,10.
Prospective participants will be referred to attend an informational session, when procedures will be explained, formal enrollment will be completed and the consent forms from the participants themselves and parental consent for their infants will be obtained. These protocols are in strict accordance with the Committee of Ethical Principles for Medical Research from TUM and has the approval of the Ethics Committee of the Hospital " Klinikum rechts der Isar". Upon acceptance participants will enter to Phase I-IV.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton pregnant women between 18 to 45 years of age in their third trimester (at least 28 weeks gestation)
排除标准
- •serious placental alterations;
- •fetal malformations;
- •maternal severe illness during pregnancy (i.e. preclampsia),
- •maternal drug or alcohol abuse,
- •preterm birth (less than 37 weeks) and
- •Cord blood pH<7,10.
结局指标
主要结局
methylation levels by Epigenome-Wide Association Study (EWAS)
时间窗: 12 months
fetal hear rate (FHR) signatures
时间窗: 12 months
The impact of prenatal stress (PS) on autonomic nervous system (ANS) activity will be analyzed by deploying advanced methods of FHR monitoring: phase-rectified signal averaging (PRSA), multidimensional FHR variability analysis and assessment of maternal-fetal heart rate synchronization. We expect that children affected by PS show early alterations of fetal ANS.
次要结局
- neuro development at 18 months of age(18 months after birth)
研究者
PD Dr. S. M. Lobmaier
Principal Investigator,
Technical University of Munich