CompletedNot Applicable

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

Turkey (Türkiye)120 participantsStarted 2023-02-17

Plain-language 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.

Who can participate

Age range

10 Weeks – 20 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Relationship Between Prenatal Maternal Anxiety and the Quality of General Movements

Timeframe: 3-5 months

Relationship Between Prenatal Maternal Depression and the Quality of General Movements

Timeframe: 3-5 months

Trial details

NCT IDNCT05694676

SponsorKaramanoğlu Mehmetbey University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-10-11

View on ClinicalTrials.gov More Cerebral Palsy trials