Relationship About Pregnancy Health and Offspring Developmental &Behavioral Outcomes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-72
SponsorChen Li
About this trial
This topic puts forward a hypothesis: genetic and environmental factors such as major depressive disorder during pregnancy, nutritional status of vitamin A, D, E, and folic acid, intestinal microecology, and bisphenol A exposure, may affect the cognitive development level of the offspring through the genetic correlation with attention deficit hyperactivity disorder, developmental delay/intellectual disability, and major depressive disorder, allelic heterogeneity and pleiotropy of ITIH3 mediated by SNP and CACNB2, neurotransmitters like dopamine, and metabolic pathways, thereby increasing the risk of attention deficit hyperactivity disorder and developmental delay/intellectual disability prevalence on offspring.
This topic planning from allelic heterogeneity and pleiotropy of attention deficit hyperactivity disorder and major depressive disorder mediated by SNP, neurotransmitters like dopamine, and metabolic pathways, explores deeply the influences on children's development level and the risk of common neurological disorder caused by genetic and environmental factors during pregnancy, looking for reasonable prevention, early diagnosis of biomarkers and therapeutic targets, in order to provide data support for further improvement and revision of national mother and infant healthcare policy .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inclusion criteria for pregnant women: Aged 20~49;
no cognitive impairment, able to complete the scale test;
Hamilton Depression Scale (HAMD questionnaire) is normal (HAMD score <8 points) or mild to moderate positive (HAMD questionnaire score: 8~35 points);
Participants are asked for their own written informed content for the study;
Disqualifiers
Patients receiving anti-depression therapy during the first 6 months of gestation or during pregnancy;
Patients with severe depression with scores of no less than 35 points in the HAMD questionnaire;
Patients with other mental disorders;
Patients with neurological diseases;
Trial population
This study is based on source material from Chongqing suburban maternity and child health hospital. The investigators randomly select the pregnant women aged 20 to 49 from the pregnancy clinics and obstetric wards, respectively construct mother-child matching and a prospective study cohort depending on whether the pregnant women with major depressive disorder or not, nutrition state of vitamin A, D, E, during pregnancy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 4 trial groupsGroup A: depressive disorder group
Group B: Nutrient-deficient group
Group C: depressive disorder and nutrient deficiency group
Group D: Neither group
Trial outcomes
Primary outcomes
1
Changes in Denver Developmental Screening Test results within 72 months of age
The DDST is taking at the age of 12 months,24 months,36months and 72months respectively ,consists of 104 items, spread 4 domains, such as gross motor, fine motor, language and personal-social skill. A normal score means no delay in any domain and no more than one caution; an abnormal score means two or more domains with two or more delays or one domain with two or more delays and another domains with one delay; a suspect score means one or more domains with one delay and more than one cautions or one domain with two or more delays; a score of untestable means enough refused items that the score would be suspect if they had been delays.
Time frame
72 months2
Changes in Gesell Developmental Schedules test results within 72 months of age
The GDS is taking at the age of 12 months,24 months, 36 months and 72 months respectively , evaluate a child's cognitive, language, motor and social-emotional responses in five strands: adaptation, gross motor, fine motor, language and personal-social skill, then schedule operates off what is known as an individual's developmental quotient (DQ). Diagnostic criteria: the score of DQ≥86: normal, 76-85: marginal , 55-75: mild mental retardation, 40-54: moderate mental retardation, 25-39: severe mental retardation, and ≤25 : extremely severe mental retardation.
Time frame
72 months3
The Vanderbilt Attention Deficit Hyperactivity Disorder Diagnostic Rating Scale
The Vanderbilt ADHD Diagnostic Rating Scale (VADRS) is for children at the age of 72 months. Scores of 2 or 3 on a single Symptom question reflect often-occurring behaviors. Scores of 4 or 5 on Performance questions reflect problems in performance. To meet the diagnosis of ADHD, one must have at least 6 positive responses to either the inattentive 9 or hyperactive 9 core symptoms, or both.
Time frame
72 months4
Changes in vitamin A
Vitamin A is measured for the mothers at first visit during 21 weeks of gestation and delivery, for the children is 24 months, 36 months and 72 months respectively. It is measured by HPLC and tandem mass spectrometry. And it is considered as Vitamin A deficiency when the concentration is below 0.70 umol/L, 0.70-1.05 umol/L is considered as marginal vitamin A deficiency, 1.05-2.56 umol/L is considered as normal range, and over 2.56 umol/L is considered as Vitamin A excess.
Time frame
72 monthsSecondary outcomes
1
Beck depression rating scale
The investigators assess Beck depression rating scale the severity of depression of the women at 21 weeks of pregnancy by Beck depression rating scale, a 21-items questionnaire. Scoring criteria: 0-13: good mental state, 14-19: mildly depressed, 20-28: moderately depressed, 29-63: severe depression.
Time frame
21 weeks of pregnancy2
Hamilton Depression Scale
The investigators assess the mood of the pregnant women at 21 weeks of pregnancy by the scale. Total score \< 8: normal; A score of 8 to 20: possible depression; A score of 20 to 35: depression; Overall score \> 35: major depression.
Time frame
21 weeks of pregnancy3
Mini-Mental State Examination
The investigators screened the questionnaire to assess cognitive impairment of the pregnant women at 21 weeks of pregnancy. Any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.
Time frame
21 weeks of pregnancy4
Changes in the Montreal Children Hospital Feeding Scale within 12 months of age
The scale measured for the children aged 6 months and 12 months respectively. The score previously calculated is the original score without standardization (rough score), and the total score of the scale (rough score) is 14-98, and then the rough score is converted into standardized score. If the standard score is less than or equal to 50, there is no difficulty in feeding; if the standard score is 51-60, there is mild difficulty in feeding; if the standard score is 61-70, there is moderate difficulty in feeding; if the standard score is greater than 70, there is severe difficulty in feeding.
Time frame
12 monthsSponsors and contacts
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Chen Li
Lead sponsor
Children's Hospital of Chongqing Medical University
Sponsor institution
Source ClinicalTrials.gov