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临床试验/NCT04417283
NCT04417283进行中(未招募)不适用

Project HOPE 1000: A Longitudinal Study of Mothers and Infants to Understand Health Outcomes Related to Pregnancy and Early-Life Exposures

Duke University2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2018年11月21日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
1,000
试验地点
2
主要终点
Development of a data repository to provide a secure, centralized storage location for samples from pregnant women.

研究概览

简要总结

The purpose of this study is to collect biological samples from pregnant women and their babies and to collect data on long-term health, school outcomes, and the use of state and county services. The information learned from this study may help identify important factors that may influence the health of mothers and babies, both short-and long-term.

详细描述

Humans pass through more biological milestones during gestation and the first two years of life (known as the "first 1000 days") than during any other period of development. Consequently, both intrinsic biology/physiology and extrinsic factors such as environmental exposures can have profound impacts on long-term health and disease outcomes. The purpose of this project is to develop a cohort of mother-infant dyads that can provide a collection of birth samples and be studied long-term - from pregnancy through early childhood - to help identify early life factors that influence lifelong health and disease. The study will include collection of specimens from pregnant women during each trimester of pregnancy, at delivery, and within the first few months after giving birth, as well as collection of specimens from the infants at birth and during their first two years of life. In addition to specimens, health information will be collected from the participants' electronic health records, and via questionnaires to assess health behaviors, social determinants, and environmental exposures. Participants may also consent for yearly review of state administrative data, including educational data, social services, and vital records. The specimens and data collected in this study will allow for assessment of the impact of different factors during pregnancy and early childhood on long-term health and well-being.

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

入选标准

  • The subject has provided a signed Informed consent prior to any study procedures.
  • Maternal age at consent of ≥ 18 years old
  • Ability to understand English or Spanish
  • Willingness to comply with and be available for all protocol procedures
  • Singleton gestation < 24 weeks 0 days
  • Receiving prenatal care at a Duke-affiliated Obstetrics clinic with the intent of delivering at Duke University Health System-affiliated hospital (including Duke University Hospital and Duke Regional Hospital)
  • Plans to have their infant seen at a Duke-affiliated Pediatrics practice after birth
  • Plans to remain in the area for two years after delivery

排除标准

  • Non-viable pregnancy
  • Having any condition that, in the opinion of the site investigators, would place the subject at unacceptable risk of injury or confound data interpretation

研究组 & 干预措施

Mother-infant dyads

Mother and/or infant participants will provide a series of biological specimens, including blood, urine, and microbiome samples. Additionally, each participant will wear a silicone wrist band each trimester to capture environmental exposures and will fill out study surveys related to diet, environmental exposures, and social factors.

结局指标

主要结局

Development of a data repository to provide a secure, centralized storage location for samples from pregnant women.

时间窗: Up to 2 years

次要结局

未报告次要终点

研究者

发起方
Duke University
申办方类型
Other
责任方
Sponsor

研究点 (2)

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