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

Completed

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

• Registration Number: NCT05694676
• Lead Sponsor: Karamanoğlu Mehmetbey University

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.

Study Timeline

• Study First Submitted: 2023-01-12
• Study First Submitted QC: 2023-01-12
• Study First Posted: 2023-01-23
• Study Start: 2023-02-17
• Primary Completion: 2023-10-11
• Study Completion: 2023-10-11
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Mothers	Beck Depression Inventory, (BDI)	Mothers aged 18 to 40 years, who have singleton pregnancy.
Mothers	State-Trait Anxiety Inventory-Trait, (STAI-T)	Mothers aged 18 to 40 years, who have singleton pregnancy.
Infants	Assessment of the quality of Genaral Movements (GMs)	Infants were born at 36-42 weeks of gestation without complication.

Primary Outcome Measures

Name	Time	Method
Relationship Between Prenatal Maternal Anxiety and the Quality of General Movements	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	3-5 months	Univariate statistical analyses will be performed to calculate differences in mothers' BDI scores between children with normal and abnormal GMs.

Secondary Outcome Measures

Name	Time	Method
Multivariate analyses will be carried out with control variables	3-5 months	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)

Trial Locations

Locations (1)

Karaman Training and Research Hospital; 🇹🇷 Karaman, Turkey