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

NCT05694676 | Completed

• 1 other identifier: 11-2022/02
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy; Infant Development; Maternal Distress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Multivariate analyses will be carried out with control variables

  3-5 months

Study Arms (2)

Mothers

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

Other: State-Trait Anxiety Inventory-Trait, (STAI-T); Other: Beck Depression Inventory, (BDI)

Infants

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

Other: Assessment of the quality of Genaral Movements (GMs)

Interventions

Assessment of the quality of Genaral Movements (GMs) OTHER

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.

Also known as: Prechtl's General movements (GMs)

Infants

State-Trait Anxiety Inventory-Trait, (STAI-T) OTHER

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).

Mothers

Beck Depression Inventory, (BDI) OTHER

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

Mothers

Eligibility Criteria

• Age: 10 Weeks - 20 Weeks
• Sex: all
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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).
• 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.

You may not qualify if:

• post partum depression and/or anxiety
• delivery complication
• 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

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead
• Karaman Training and Research Hospital: collaborator

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Aynur Basaran, MD,Prof

  Karaman Training and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Prof

Study Record Dates

• First Submitted: January 12, 2023
• First Posted: January 23, 2023
• Study Start: February 17, 2023
• Primary Completion: October 11, 2023
• Study Completion: October 11, 2023
• Last Updated: December 8, 2023

Record last verified: 2023-12

Locations

TU (1)