Pregnancy Cohort Study: Pregnancy as a Window to Future Health
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- Hypertensive disorders of pregnancy
研究概览
简要总结
The goal of this observational cohort study is to gain deep insights into how metabolic disorders such as obesity or diabetes during pregnancy affect the metabolic and cardiovascular health of mother and child in the short and long term.
It will investigate the following questions:
- How do maternal metabolic disorders affect pregnancy outcomes?
- How do maternal metabolic disorders affect fetal growth?
- How do maternal metabolic disorders affect the newborn's metabolism and body composition?
- How do maternal metabolic disorders during pregnancy affect breast milk composition?
- How do maternal metabolic disorders during pregnancy affect the metabolic health of the mother after birth? Participants in this study are pregnant women who will be asked to come to the clinics for three visits during their pregnancy, as well as for the delivery of their baby, and one time 2-3 months thereafter. At each visit, researchers will perform physical examinations (such as body composition measurements) and collect biological samples (blood, urine, saliva), clinical information, and lifestyle data. At birth, researchers will collect cord blood and breast milk as well as clinical data of the delivery and the health of the baby. Researchers will measure body fat in newborn babies and at 2-3 months of age.
详细描述
Pregnancy is a sensitive and determining period in life where maternal and environmental cues can influence mother and offspring health short and long term. Negative exposures in pregnancy can have long term consequences, such as higher risk for development or aggravation of obesity, metabolic and cardiovascular diseases. However, preventive measures such as life style interventions can be particularly effective (window of opportunity) and could mitigate disease trajectories.
During a healthy pregnancy, a multitude of fine-tuned physiological adaptations takes place to meet the demands of the developing fetus and prepare maternal organism for delivery and lactation. These physiological changes affect the maternal metabolism, cardiovascular system, immune system, microbiome, or endocrine system. Unfavorable or adverse maternal factors (e.g. endocrine, genetic, metabolic, lifestyle factors) may compromise these adaptations, promoting pregnancy complications such as gestational diabetes (GDM), hypertensive pregnancy diseases, fetal growth restriction, fetal overgrowth, or preterm birth. These pregnancy pathologies not only pose an immediate health risk to both mother and child, but also may negatively impact the longer-term cardiovascular, endocrine, and metabolic health of both.
Offspring exposed in utero to maternal diabetes, hypertensive diseases or maternal obesity are at higher risk of developing obesity, diabetes of cardiovascular disorders later in life. For the mother, each pregnancy loads a metabolic burden, which is aggravated by pregnancy complications, also increasing the mother's risk of developing metabolic or cardiovascular disease later in life.
Therefore, prediction and risk evaluation, early diagnosis and prognosis, safe (non-invasive) therapeutic strategies are urgently needed to provide intervention as early as possible (pre-conceptional, during pregnancy and postpartum) to avoid potential manifestations of long-term health problems. Due to the relatively short duration of pregnancy and the often increased health awareness of expectant mothers, pregnancy is an ideal phase to identify origins of disease, evaluate personalized diagnostic and predictive markers, as well as preventive strategies.
In the recent years, the concept of deep phenotyping during pregnancy has emerged as a means to tackle the current inadequate understanding on the pathobiology of pregnancy related diseases and heath trajectories.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •ongoing pregnancy prior to 14th gestational week, women with child wish; above 18 years of age, giving informed consent
排除标准
- •gestational age > 14th week of gestation; below 18 years of age; fetal genetic anomalies /malformation
结局指标
主要结局
Hypertensive disorders of pregnancy
时间窗: From enrolment to child birth; 6 months
gestational hypertension and preeclampsia, assessed through medical chart review.
Neonatal body composition at birth
时间窗: between delivery and 48h postpartum
Measured as fat mass and fat-free mass by air displacement plethysmography (via PEAPOD)
Neonatal C-peptide in cord blood
时间窗: at birth
Concentrations of C-peptide in cord blood
Neonatal cytokine profile
时间窗: at birth
Neonatal inflammatory cytokines will be measured in cord blood serum collected at birth using multiplexing cytokine assays.
Neonatal epigenetic profile
时间窗: at birth
Epigenomic profile of the umbilical cord blood measured by DNA methylation
Maternal adiposity
时间窗: From enrolment to 8-12 weeks post partum
Measured as fat mass and fat-free mass by air displacement plethysmography (via BODPOD) at 10-14 weeks, 20-24 weeks and 34-37 weeks of gestation and 8-12 weeks post partum.
Maternal fasting blood glucose
时间窗: from enrollment to 8-12 weeks postpartum
Fasting blood glucose as measured in mg/mL from NaF blood tubes at 10-14 weeks, 24-24 weeks, 34-37 weeks of gestation and 8-12 postpartum.
Maternal blood pressure
时间窗: From enrolment to 8-12 weeks postpartum
Blood pressure will be measured at 10-14 weeks, 24-28 weeks and 34-37 weeks of gestation and 8-12 weeks post partum.
Maternal lipid profiles - triglycerides
时间窗: From enrolment to 8-12 weeks post partum
Analysis of serum lipid profiles: triglycerides at 3 time points during pregnancy (10-14 weeks (wks); 24-28wks; 34-37wks), and 8-12 wks postpartum.
Maternal lipid profiles: phospholipids
时间窗: From enrolment to 8-12 weeks post partum
Analysis of serum lipid profiles: phospholipids at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.
Maternal lipid profiles: free fatty acids
时间窗: From enrolment to 8-12 weeks post partum
Analysis of serum lipid profiles: free fatty acids at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.
Maternal lipid profiles: total cholesterol
时间窗: From enrolment to 8-12 weeks post partum
Analysis of serum lipid profiles: total cholesterol at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.
Maternal lipid profiles: HDL cholesterol
时间窗: From enrolment to 8-12 weeks post partum
Analysis of serum lipid profiles: HDL cholesterol at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.
Maternal lipid profiles: LDL cholesterol
时间窗: From enrolment to 8-12 weeks post partum
Analysis of serum lipid profiles: LDL cholesterol at 3 time points during pregnancy (10-14wks; 24-28wks; 34-37wks), and 8-12wks postpartum.
Maternal endothelial function
时间窗: From enrolment to 8-12 weeks post partum
measured as pulse wave velocity using a Vicorder®.
Maternal cytokine profile
时间窗: From enrolment to 8-12 weeks postpartum
Serum cytokines will be analysed by multiplexing at all visits during pregnancy and postpartum.
Gestational diabetes
时间窗: From enrolment to child birth; 6 months
assessed through 75g 2h oral glucose tolerance test performed at 24-28 weeks of gestation.
次要结局
- Human milk oligosaccharide (HMO) profile in maternal blood(From enrolment to 8-12 weeks postpartum)
- Human milk oligosaccharide (HMO) profile in cord blood(at birth)
- Human milk oligosaccharide (HMO) profile in maternal urine(From enrolment to 8-12 weeks post partum)
- Human milk oligosaccharide (HMO) profile in breast milk(from child birth to 8-12 weeks postpartum)
- Adverse pregnancy outcome(From enrolment to child birth; 6 months)