Cerebral PalsyNCT05694676
Relationship Between Prenatal Maternal Distress and the Quality of General Movements at 3 Months
An observational study of Cerebral Palsy and Infant Development, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 20 weeks
- Conditions the study is for
- Cerebral Palsy, Infant Development, Maternal Distress
- What is being tested?
- Assessment of the quality of Genaral Movements (GMs), State-Trait Anxiety Inventory-Trait, (STAI-T) and Beck Depression Inventory, (BDI)
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2023to 11 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 20 weeks
- All sexes
- Child
Study population: Mothers aged 18 to 40 years, who have singleton pregnancy. Infants were born at 36-42 weeks of gestation without complication.
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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karaman Training and Research Hospital
Karaman, 70200
About this study
Official title: Relationship Between Prenatal Maternal Depression and Anxiety and the Quality of General Movements of Healthy Term Infants 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.
Read the 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
- Being tested
- Assessment of the quality of Genaral Movements (GMs), State-Trait Anxiety Inventory-Trait, (STAI-T), Beck Depression Inventory, (BDI)
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the quality of Genaral Movements (GMs)Other
Also called Prechtl's General 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.
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
| Study group | Role | What they receive |
|---|---|---|
| Mothers | Mothers aged 18 to 40 years, who have singleton pregnancy. Receives: 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. Receives: Other: Assessment of the quality of Genaral Movements (GMs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3-5 months
Secondary outcomes (1)
Multivariate analyses will be carried out with control variables
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)
Measured: 3-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2023
- Study start17 Feb 2023
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Responsible party
- Principal investigator, Aynur Başaran, Karamanoğlu Mehmetbey University
- Investigators
- Aynur Basaran, MD,Prof, Study director, Karaman Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05694676
- Sponsor's protocol ID
- 11-2022/02
- Status last verified
- Dec 2023
- First submitted
- 12 Jan 2023
- Last updated
- 8 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Prenatal Maternal Depression and Anxiety and the Quality of General Movements of Healthy Term Infants at 3 Months
- ClinicalTrials.gov ID
- NCT05694676
- Acronym / sponsor ID
- 11-2022/02
- Conditions
- Cerebral Palsy, Infant Development, Maternal Distress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Collaborators
- Karaman Training and Research Hospital
- Study start
- 17 Feb 2023 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 23 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mothers | – | Other: State-Trait Anxiety Inventory-Trait, (STAI-T), Other: Beck Depression Inventory, (BDI)Mothers aged 18 to 40 years, who have singleton pregnancy. |
| Infants | – | Other: Assessment of the quality of Genaral Movements (GMs)Infants were born at 36-42 weeks of gestation without complication. |
Who may qualify
- Ages
- 10 to 20 weeks
- Sex
- All
- Age groups
- Child
- Study population
- Mothers aged 18 to 40 years, who have singleton pregnancy. Infants were born at 36-42 weeks of gestation without complication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of the quality of Genaral Movements (GMs)Also: Prechtl's General 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. | Other | Infants |
| 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). | Other | Mothers |
| 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 | Other | Mothers |
Primary outcome
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.
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.
1 secondary outcome
Multivariate analyses will be carried out with control variables
Time frame: 3-5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aynur Basaran, MD,Prof study director
Karaman Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Palsy and Infant Development, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship Between Prenatal Maternal Anxiety and the Quality of General Movements (time frame: 3-5 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.