Relationship Between Prenatal Maternal Distress and the Quality of General Movements at 3 Months

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

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.

Study Overview

• Status: Completed
• Conditions: Cerebral Palsy; Infant Development; Maternal Distress
• Intervention / Treatment: Other: State-Trait Anxiety Inventory-Trait, (STAI-T); Other: Beck Depression Inventory, (BDI); Other: Assessment of the quality of Genaral Movements (GMs)

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.

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

• Study Contact: Name: Aynur Basaran, MD, Prof; Phone Number: +90 537 562 0666; Email: aynurbasaran@gmail.com
• Study Contact Backup: Name: Ozlem Dulger, MD; Phone Number: +90 532 606 4380; Email: ozlem_dulger@yahoo.com.tr

Study Locations

• Turkey
  • Karaman, Turkey, 70200
    • Karaman Training and Research Hospital
    • Contact: Aynur Basaran; Phone Number: +90 338 226 3225; Email: aynurbasaran@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months to 4 months (Child)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Mothers aged 18 to 40 years, who have singleton pregnancy.

Infants were born at 36-42 weeks of gestation without complication.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mothers; Mothers aged 18 to 40 years, who have singleton pregnancy.	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
Infants; Infants were born at 36-42 weeks of gestation without complication.	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 Names: Prechtl's General movements (GMs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship Between Prenatal Maternal Anxiety and the Quality of General Movements	Univariate statistical analyses will be performed to calculate differences in mothers' STAI-T scores between children with normal and abnormal GMs.	3-5 months
Relationship Between Prenatal Maternal Depression and the Quality of General Movements	Univariate statistical analyses will be performed to calculate differences in mothers' BDI scores between children with normal and abnormal GMs.	3-5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Multivariate analyses will be carried out with control variables	Significant primary outcome measures will be controlled with: Maternal age (years); Maternal education (Literate, Elementary school, Middle School, High school, University); Marital status (married, separated, divorced, widow); Maternal height (m); Maternal weight before pregnancy (kg); Maternal weight at birth (kg); Maternal BMI before pregnancy (Maternal weight before pregnancy/Maternal height) (kg/m^2); Maternal BMI at birth (Maternal weight at birth/Maternal height)(kg/m^2); Type of delivery (Vaginal spontaneous, Instrumental, Assisted vaginal, Elective C/S, Emergency C/S),; Birth order; Gestational age at birth (days); Infant birth weight (grams); Infant birth height (cm); Infant birth head circumference (cm); Infant gender (boy, girl); Infant 1st and 5th minute Apgar scores; Breastfeeding (>6wk, <=6 wk)	3-5 months

Collaborators and Investigators

• Sponsor: Karamanoğlu Mehmetbey University
• Collaborators: Karaman Training and Research Hospital
• Investigators: Study Director: Aynur Basaran, MD,Prof, Karaman Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2023
• Primary Completion (Actual): October 11, 2023
• Study Completion (Actual): October 11, 2023

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 23, 2023

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 7, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: 11-2022/02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No