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临床试验/NCT05951738
NCT05951738招募中不适用

Exposures to PRenatal and Postnatal Adverse Stressful Experiences: Multimodal Omics Signatures Underlying Stress Vulnerability and Resilience and as Novel Targets for Preventive Strategies.

IRCCS Centro San Giovanni di Dio Fatebenefratelli5 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2022年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
5
主要终点
Differentially expressed genes and biological pathways modulation

研究概览

简要总结

The study aims at identifying:

  1. specific biological and molecular alterations associated with development of depression in pregnancy or risk of it.
  2. specific biological and molecular alterations due to exposure to maternal depression in utero that are still present in the offspring, that could possibly mediate the development of negative outcomes, and which are the possible clinical moderators of the associated risk;
  3. whether antidepressant therapies prescribed by personal physician and the use of digital tools can have a preventive effect in the transmission of the risk from mothers to babies and in the development of depressive symptoms in high-risk pregnant women;

In order to achieve these, 80 pregnant women with depression, 80 at high-risk and 80 controls will be recruited and clinically monitored over pregnancy and postpartum along with their babies, specifically at these timepoints: 25th and 32nd weeks of gestation, 1 week postpartum, 4 weeks postpartum, 8 weeks postpartum, 12 months postpartum.

Women, based on their clinician choice, will receive antidepressants and will be provided with a smartphone app to monitor them, using a combination of personalised, daily self-reported assessments and sensors for passive data collection to cover mental and physical health.

Blood and saliva samples from pregnant women will be collected at the 25th and 32nd week of gestation to perform biological analyses.

Saliva samples from babies will be collected at 8 weeks and 12 months postpartum to perform biological analyses.

Clinical and psychological data will be collected from women at all timepoints.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

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

  • Pregnant women of a singleton pregnancy
  • Age ≥ 18 years

排除标准

  • Uterine anomalies and obstetric complications
  • Comorbidity with severe or chronic diseases
  • Substance abuse
  • Language barrier

结局指标

主要结局

Differentially expressed genes and biological pathways modulation

时间窗: 25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.

次要结局

  • Rate and profile of DNA methylation(25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.)
  • Cortisol levels(25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.)
  • Smartphone app utility(From 25th of gestation to 12 months postpartum)
  • Immune-related factors levels(25th and 32nd weeks of gestation for pregnant women; 8 weeks and 12 months postpartum for babies.)

研究者

发起方
IRCCS Centro San Giovanni di Dio Fatebenefratelli
申办方类型
Other
责任方
Principal Investigator
主要研究者

Annamaria Cattaneo

Head of the Biological Psichiatry unit

IRCCS Centro San Giovanni di Dio Fatebenefratelli

研究点 (5)

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