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

NCT ID: NCT05694676

Last Updated: 2023-12-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-02-17
• Study Completion Date: 2023-10-11

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.

Conditions

Cerebral Palsy; Infant Development; Maternal Distress

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Mothers

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

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

Intervention Type: 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).

Beck Depression Inventory, (BDI)

Intervention Type: 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

Infants

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

Assessment of the quality of Genaral Movements (GMs)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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).

Intervention Type: 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

Intervention Type: OTHER

Other Intervention Names

Prechtl's General movements (GMs)

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
• 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.

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

• Minimum Eligible Age: 10 Weeks
• Maximum Eligible Age: 20 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Karaman Training and Research Hospital

OTHER

Sponsor Role: collaborator

Karamanoğlu Mehmetbey University

OTHER

Sponsor Role: lead

Responsible Party

Aynur Başaran

MD, Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Aynur Basaran, MD,Prof

Role: STUDY_DIRECTOR

Karaman Training and Research Hospital

Locations

Karaman Training and Research Hospital

Karaman, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

11-2022/02

Identifier Type: -

Identifier Source: org_study_id