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Clinical Trials/NCT05694676
NCT05694676
Completed
Not Applicable

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

Karamanoğlu Mehmetbey University1 site in 1 country120 target enrollmentFebruary 17, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cerebral Palsy
Sponsor
Karamanoğlu Mehmetbey University
Enrollment
120
Locations
1
Primary Endpoint
Relationship Between Prenatal Maternal Anxiety and the Quality of General Movements
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 17, 2023
End Date
October 11, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Karamanoğlu Mehmetbey University
Responsible Party
Principal Investigator
Principal Investigator

Aynur Başaran

MD, Prof

Karamanoğlu Mehmetbey University

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Relationship Between Prenatal Maternal Anxiety and the Quality of General Movements

Time Frame: 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

Time Frame: 3-5 months

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

Secondary Outcomes

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

Study Sites (1)

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