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临床试验/NCT06340152
NCT06340152招募中不适用

Multi-Omics for Maternal Health After Preeclampsia

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 1,100 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,100
试验地点
1
主要终点
Gestational hypertension

研究概览

简要总结

To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies.

详细描述

The investigators will recruit and retain a diverse population of pregnant women who are high- and low-risk for hypertensive disorders of pregnancy/preeclampsia (HDP/PE) for longitudinal collection of phenotypic and environmental exposure measures and biosamples for integrative analysis of phenotypic, environmental, and multi-omic data to understand links between development of HDP/PE and associated fetal pathologies during pregnancy, as well as postpartum maternal health. Participation in the study will begin no later than the second trimester of pregnancy (enrollment by 24 weeks of gestation) and continue through the first year postpartum. Over the course of the study, biospecimens and relevant surveys and cardiovascular assessments will be collected at specified intervals/time-points, as outlined in the table below. In-person study visits should take no more than 30 minutes. Relevant medical information collected as part of routine clinical care will be obtained from the electronic medical record (EMR). The study will take place at UCSD and VUMC prenatal clinics and hospital labor and delivery units, or another private location of the participants choosing, such as their home or office.

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

入选标准

  • Pregnant women 18 years of age to 50 years of age
  • 10-24 weeks gestation at time of enrollment
  • Singleton pregnancy
  • Planning to deliver at a study site (UCSD or VUMC)

排除标准

  • Inability to give informed consent
  • Intrauterine fetal demise
  • Fetal genetic or structural anomaly
  • Institutionalization for psychiatric disorder, mental deficiency or incarcerated
  • Active or history of malignancy requiring major surgery or systemic chemotherapy
  • Multi-fetal gestation or a twin demise at any gestational age
  • Known maternal or fetal chromosomal anomalies
  • Patients who plan to keep their placenta after delivery

结局指标

主要结局

Gestational hypertension

时间窗: 2nd trimester - Delivery

Postpartum hypertension

时间窗: Delivery - 13 months postpartum

Preeclampsia

时间窗: 2nd trimester - 13 months postpartum

次要结局

  • Postpartum cardiovascular disease(Delivery - 13 months postpartum)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Louise Laurent, MD/PhD

Professor

University of California, San Diego

研究点 (1)

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