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

K

Karamanoğlu Mehmetbey University

Status

Completed

Conditions

Maternal Distress
Cerebral Palsy
Infant Development

Treatments

Other: Beck Depression Inventory, (BDI)
Other: State-Trait Anxiety Inventory-Trait, (STAI-T)
Other: Assessment of the quality of Genaral Movements (GMs)

Study type

Observational

Funder types

Other

Identifiers

NCT05694676
11-2022/02

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

10 to 20 weeks old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

120 participants in 2 patient groups

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

Trial contacts and locations

1

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Central trial contact

Ozlem Dulger, MD; Aynur Basaran, MD, Prof

Data sourced from clinicaltrials.gov

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