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临床试验/NCT05694676
NCT05694676已完成不适用

Relationship Between Prenatal Maternal Depression and Anxiety and the Quality of General Movements of Healthy Term Infants at 3 Months

Karamanoğlu Mehmetbey University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2023年2月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
Relationship Between Prenatal Maternal Anxiety and the Quality of General Movements

研究概览

简要总结

Depression and anxiety symptoms are common during pregnancy which may disturb the intrauterine environment by affecting the mother's physiological responses to stress, and ultimately impair fetal and postnatal development. There is increasing evidence about the effects of maternal distress on young brain tissue leading to some structural changes. The neurological footprints of these structural changes on the young brain may be caught early in life by a video assessment of General Movements (GMs) quality.

详细描述

Depression and anxiety symptoms are common during pregnancy and are estimated to affect 7% - 20% of pregnant women, constituting significant risks for mothers and babies. Depression and anxiety may disturb the intrauterine environment by affecting the mother's physiological responses to stress, and ultimately impair fetal and postnatal development. Increasing evidence shows that prenatal exposure to maternal depression and anxiety is associated with several lifelong adverse outcomes in children, including physical health problems, emotional and behavioral difficulties, and low verbal IQ.

Such maladaptive outcomes are thought to have a neurobiological basis and there is increasing evidence about the effects of maternal distress on young brain tissue leading to some structural changes. However, what is more important is that the neurological footprints of these structural changes on the young brain can be caught early in life. The neurological status of infants can be determined early in life by video assessment of General Movements (GMs) quality. In this study at the age of 3 months, a video assessment of the quality of GMs will be performed to evaluate neurologic conditions.

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
10 Weeks 至 20 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Mothers aged 18 to 40 years,
  • Singleton pregnancy
  • No smoking during prengnancy
  • No illicit drug or alcohol use during pregnancy,
  • No major health conditions requiring invasive treatments (e.g., dialysis, blood transfusions, chemotherapy),
  • No diagnosis of psychotic illnesses (eg, schizophrenia,bipolar or borderline personality disorder), and
  • No major autoimmune diseases
  • No pregnancy-related complications: (including prenatal infection, pregnancy-included hypertension, gestational diabetes, oligohydramnios, polyhydramnios, preterm labor, vaginal bleeding, placenta previa, or anemia).
  • Infant inclusionary criteria:
  • infants were born at 36-42 wk of gestation
  • uncomplicated singleton birth,
  • no pre-existing neurologic conditions or major head trauma, neonatal intensive care unit stay limited to observation only (ie, no interventions), and
  • infant discharged from the hospital with the mother.

排除标准

  • post partum depression and/or anxiety
  • delivery complication
  • Infant exclusion criteri:
  • infant birth before 36 weeks gestation
  • infant weight lower 2500gr at birth
  • Apgar score 0f <7 at 5 minutes
  • Major neonatal complications
  • Identified neurologic, genetic or congenital syndrome

结局指标

主要结局

Relationship Between Prenatal Maternal Anxiety and the Quality of General Movements

时间窗: 3-5 months

Univariate statistical analyses will be performed to calculate differences in mothers' STAI-T scores between children with normal and abnormal GMs.

Relationship Between Prenatal Maternal Depression and the Quality of General Movements

时间窗: 3-5 months

Univariate statistical analyses will be performed to calculate differences in mothers' BDI scores between children with normal and abnormal GMs.

次要结局

  • Multivariate analyses will be carried out with control variables(3-5 months)

研究者

发起方
Karamanoğlu Mehmetbey University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Aynur Başaran

MD, Prof

Karamanoğlu Mehmetbey University

研究点 (1)

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