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.
Full Title of Study: “Relationship Between Prenatal Maternal Depression and Anxiety and the Quality of General Movements of Healthy Term Infants at 3 Months”
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: June 30, 2023
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.
- Other: Assessment of the quality of Genaral Movements (GMs)
- The variation, complexity and fluency of movements over a video recording is done and the quality of GMs is classified as normal-optimal, normal-suboptimal, mildly abnormal, and definitely abnormal movements.
- Other: State-Trait Anxiety Inventory-Trait, (STAI-T)
- The scale consists of 20 items in total and provides a four-point Likert type measurement (1- anxiety symptom is not present, 4- the symptom lasts all the time). Scores range from 20 (low anxiety) to 80 (high anxiety).
- Other: Beck Depression Inventory, (BDI)
- BDI contains 21 items and rates the depressive symptoms for the last week. Each item has four options and is scored between 0 and 3. The total score ranges from 0 to 63. Higher scores indicate more severe depression
Arms, Groups and Cohorts
- Mothers aged 18 to 40 years, who have singleton pregnancy.
- Infants were born at 36-42 weeks of gestation without complication.
Clinical Trial Outcome Measures
- 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.
- Multivariate analyses will be carried out.
- Time Frame: 3-5 months
- Significant primary outcome measures will be controlled with: Maternal age, Maternal gravida and parity, Maternal education, marital status, Maternal BMI before pregnancy and at birth, Type of delivery, and Gestational age at birth, Birth weight, Birth height, Birth head circumference, Gender, 1st and 5th minute Apgar scores, and Breastfeeding
Participating in This Clinical Trial
Mothers 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 – 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. Mothers 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
Gender Eligibility: All
Minimum Age: 10 Weeks
Maximum Age: 20 Weeks
- Lead Sponsor
- Karamanoğlu Mehmetbey University
- Karaman Training and Research Hospital
- Provider of Information About this Clinical Study
- Principal Investigator: Aynur Başaran, MD – Karamanoğlu Mehmetbey University
- Overall Contact(s)
- Aynur Basaran, +90 537 562 0666, email@example.com
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