Clinical trial NCT05694676: Relationship Between Prenatal Maternal Distress and the Quality of General Movements at 3 Months
Official title: Relationship Between Prenatal Maternal Depression and Anxiety and the Quality of General Movements of Healthy Term Infants at 3 Months
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Infant Development
Maternal Distress
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
Collaborators: name: Karaman Training and Research Hospital
First posted: 2023-01-23
Enrollment: 120
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Relationship Between Prenatal Maternal Anxiety and the Quality of General Movements
timeFrame: 3-5 months
measure: Relationship Between Prenatal Maternal Depression and the Quality of General Movements
timeFrame: 3-5 months
Secondary outcomes:
measure: Multivariate analyses will be carried out with control variables
timeFrame: 3-5 months
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
Study officials:
affiliation: Karaman Training and Research Hospital
name: Aynur Basaran, MD,Prof
role: STUDY_DIRECTOR
References: