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Completed

NCT Number: NCT05694676

Relationship Between Prenatal Maternal Distress and the Quality of General Movements 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.

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Key information

Age range

10 week–20 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Prechtl's General movements (GMs)

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).

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Multivariate analyses will be carried out with control variables

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Karamanoğlu Mehmetbey University

Other

Collaborators

  • Karaman Training and Research Hospital

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 23, 2023
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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