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Relationship About Pregnancy Health and Offspring Developmental &Behavioral Outcomes (APCSAHAODBO)

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ClinicalTrials.gov Identifier: NCT04017286
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 25, 2019
Sponsor:
Information provided by (Responsible Party):
Chen Li, Children's Hospital of Chongqing Medical University

Brief Summary:

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 .


Condition or disease
Children Behavior Problem Pregnancy

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Years
Official Title: A Prospective Cohort Study of the Association Between Pregnancy Health and Offspring Developmental & Behavioral Outcomes(Multi-Centered)
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 31, 2025
Estimated Study Completion Date : December 31, 2028

Group/Cohort
depressive disorder group
At 21 weeks of pregnancy, women diagnosed with depressive disorder by the Hamilton depression scale and Beck depression rating scale and their offspring were enrolled.
Nutrient-deficient group
Nutrients (Vitamin A,D,E) were tested at 21 weeks of pregnancy, and pregnant women with one or more nutrient deficiencies or insufficiency and their offspring were enrolled.
depressive disorder and nutrient deficiency group
At 21 weeks of pregnancy, pregnant women with depressive disorder and nutrient deficiency or insufficiency and their offspring were enrolled.
Neither group
At 21 weeks of pregnancy, pregnant women without depressive disorder and nutrient deficiency or insufficiency and their offspring were enrolled.



Primary Outcome Measures :
  1. Changes in Denver Developmental Screening Test results within 72 months of age [ Time Frame: 72 months ]
    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.

  2. Changes in Gesell Developmental Schedules test results within 72 months of age [ Time Frame: 72 months ]
    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.

  3. The Vanderbilt Attention Deficit Hyperactivity Disorder Diagnostic Rating Scale [ Time Frame: 72 months ]
    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.

  4. Changes in vitamin A [ Time Frame: 72 months ]
    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.

  5. Changes in Vitamin D [ Time Frame: 72 months ]
    Vitamin D 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. the measurement of the concentration of 25-OH-D3 as that of vitamin D. It is below 30 nmol/L considered as Vitamin D deficiency, 30-50 nmol/L considered as Vitamin D insufficiency, over 50 nmol/L considered as Vitamin D sufficiency.

  6. Changes in Vitamin E [ Time Frame: 72 months ]
    Vitamin E 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. It is normal range with the concentration of 11.6-46.4 umol/L.

  7. Homocysteine [ Time Frame: delivery ]
    Homocysteine is measured for the mothers at first visit during 21 weeks of gestation and delivery. It is measured by HPLC and tandem mass spectrometry. The concentration of homocysteine less than 11.4umol/L is normal for men and less than 10.4 umol/L for women.

  8. Bisphenol A [ Time Frame: 72 months ]
    The concentration of bisphenol A is measured for mother at delivery and for children aged 2 and 6. The investigators measured the concentration of urine in order to compare the differences of children between high dose of BPA with low dose of BPA. However, as far as we know, the normal range of bisphenol A has not been reported at home and abroad. We also want to explore the relationship between bisphenol A and neuropsychiatric development.

  9. the Adaptive Scale of Infant and Children [ Time Frame: 72 months ]
    This scale is assessed for the children at the age of 72 months. Extremely low (≤5), severely low (6 points), moderately low (8 points), marginal (9 points), normal (10 points), more than normal (11 points), excellent (12 points), very good (13 points).


Secondary Outcome Measures :
  1. Beck depression rating scale [ Time Frame: 21 weeks of pregnancy ]
    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.

  2. Hamilton Depression Scale [ Time Frame: 21 weeks of pregnancy ]
    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.

  3. Mini-Mental State Examination [ Time Frame: 21 weeks of pregnancy ]
    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.

  4. Changes in the Montreal Children Hospital Feeding Scale within 12 months of age [ Time Frame: 12 months ]
    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.

  5. Change of weight for height Z-score(WHZ) [ Time Frame: 72 months ]
    The measurement of body length/height and weight (the average of three consecutive measurements) for age is at 3 months, 6 months,12 months,24 months,36 months and 72 months respectively and calculated by WHO2006 curve. It's considered abnormal when the WHZ is below P3 or over P97, the normal range is between P3~P97.

  6. Change of the height for age Z-score(HAZ) [ Time Frame: 72 months ]
    The measurement of body length/height (the average of three consecutive measurements) for age is at 3 months, 6 months,12 months , 24 months, 36 months and 72 months respectively and calculated by WHO2006 curve. It's considered abnormal when the HAZ is below P3 or over P97, the normal range is between P3~P97.

  7. Change of the weight for Age Z-score(WAZ) [ Time Frame: 72 months ]
    The measurement of weight (the average of three consecutive measurements) for age is at 3 months, 6 months,12 months , 24 months, 36 months and 72 months respectively and calculated by WHO2006 curve . It's considered abnormal when the WAZ is below P3 or over P97, the normal range is between P3~P97.

  8. Ferritin [ Time Frame: 24 months ]
    The ferritin is measured for mothers at 21 weeks of pregnancy and for children at the age of 24 months. It is measured by chemiluminescence method. It is normal when the concentration of ferritin is between 5-148 ng/ml for girls and 28-365 ng/ml for boys.

  9. Folate [ Time Frame: 24 months ]
    The folate is measured for mothers at 21 weeks of pregnancy and for children at the age of 24 months. It is measured by chemiluminescence method. It is normal when the concentration of folate is greater than 5.38 ng/ml.

  10. Activity of Daily Living Scale [ Time Frame: 21 weeks of pregnancy ]
    The investigators screened the questionnaire to assess cognitive impairment of the pregnant women at 21 weeks of pregnancy. ADLs can be broken down into the following categories: personal hygiene, continence management, dressing, feeding, ambulating. The evaluation results can be analyzed according to the total score, subscale score and single score. The total score < 16 points, completely normal; > 16 points, with varying degrees of functional decline, and the maximum score is 64 points. Single points; 1 point :normal, 2-4 points : functional decline.≥2 items with a score ≥3 points, or a total score ≥ 22 points, are considered to have obvious dysfunction.


Biospecimen Retention:   Samples With DNA
In the investigator's study, partly samples of material from research participants are retained in a biorepository.For example, cord blood from newborn, DNA, venous blood and urine. A few of hair is also collected at the same time and stored for future measurements (used to extract DNA in case that the cord blood is unsufficient or DNA extraction from the blood fails unexpectedly).


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Ages Eligible for Study:   3 Months to 72 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study 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.
Criteria

Inclusion Criteria:

  1. Inclusion criteria for pregnant women: Aged 20~49;
  2. no cognitive impairment, able to complete the scale test;
  3. Hamilton Depression Scale (HAMD questionnaire) is normal (HAMD score <8 points) or mild to moderate positive (HAMD questionnaire score: 8~35 points);
  4. Participants are asked for their own written informed content for the study;

Exclusion Criteria:

  1. Patients receiving anti-depression therapy during the first 6 months of gestation or during pregnancy;
  2. Patients with severe depression with scores of no less than 35 points in the HAMD questionnaire;
  3. Patients with other mental disorders;
  4. Patients with neurological diseases;
  5. Patients with cognitive dysfunction.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04017286


Contacts
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Contact: Li Chen, MD (+86)136 7762 0103 ext +86 chenli2012@126.com

Locations
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China, Chongqing
The People's Hospital of Yubei District of Chongqing City Not yet recruiting
Chongqing, Chongqing, China, 401120
Contact: chun Y Su, MD    (+86)189 9613 7157 ext +86    1501614339@qq.com   
Chongqing First People's Hospital of Liangjiang New Area Not yet recruiting
Chongqing, Chongqing, China, 401121
Contact: Chao Li, MB    (+86)13896164470 ext +86    695040138@qq.com   
The Central Hospital of Jiangjin District of Chongqing City Not yet recruiting
Chongqing, Chongqing, China, 402260
Contact: Feng Li, Master    (+86)136 6801 9599 ext +86    123495256@qq.com   
Wanzhou Health Center for Women and Children Recruiting
Chongqing, Chongqing, China, 404100
Contact: zhi W Shen, Master    (+86)137 0945 8848 ext +86    13709458848@126.com   
China, Hainan
The Maternal and Child Health Hospital of Hainan Province Not yet recruiting
Haikou, Hainan, China, 570000
Contact: Ling Li, Master    (+86)186 8985 3985 ext +86    liling53985@126.com   
Sponsors and Collaborators
Chen Li
Investigators
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Study Director: Li Chen, MD Children's Hospital of Chongqing Medical University
Principal Investigator: Tanya Froehlich, MD,MS Children's Hospital Medical Center, Cincinnati
Study Chair: yu T Li, MS Children's Hospital of Chongqing Medical University

Publications:
Cross-Disorder Group of the Psychiatric Genomics Consortium, Lee SH, Ripke S, Neale BM, Faraone SV, Purcell SM, Perlis RH, Mowry BJ, Thapar A, Goddard ME, Witte JS, Absher D, Agartz I, Akil H, Amin F, Andreassen OA, Anjorin A, Anney R, Anttila V, Arking DE, Asherson P, Azevedo MH, Backlund L, Badner JA, Bailey AJ, Banaschewski T, Barchas JD, Barnes MR, Barrett TB, Bass N, Battaglia A, Bauer M, Bayés M, Bellivier F, Bergen SE, Berrettini W, Betancur C, Bettecken T, Biederman J, Binder EB, Black DW, Blackwood DH, Bloss CS, Boehnke M, Boomsma DI, Breen G, Breuer R, Bruggeman R, Cormican P, Buccola NG, Buitelaar JK, Bunney WE, Buxbaum JD, Byerley WF, Byrne EM, Caesar S, Cahn W, Cantor RM, Casas M, Chakravarti A, Chambert K, Choudhury K, Cichon S, Cloninger CR, Collier DA, Cook EH, Coon H, Cormand B, Corvin A, Coryell WH, Craig DW, Craig IW, Crosbie J, Cuccaro ML, Curtis D, Czamara D, Datta S, Dawson G, Day R, De Geus EJ, Degenhardt F, Djurovic S, Donohoe GJ, Doyle AE, Duan J, Dudbridge F, Duketis E, Ebstein RP, Edenberg HJ, Elia J, Ennis S, Etain B, Fanous A, Farmer AE, Ferrier IN, Flickinger M, Fombonne E, Foroud T, Frank J, Franke B, Fraser C, Freedman R, Freimer NB, Freitag CM, Friedl M, Frisén L, Gallagher L, Gejman PV, Georgieva L, Gershon ES, Geschwind DH, Giegling I, Gill M, Gordon SD, Gordon-Smith K, Green EK, Greenwood TA, Grice DE, Gross M, Grozeva D, Guan W, Gurling H, De Haan L, Haines JL, Hakonarson H, Hallmayer J, Hamilton SP, Hamshere ML, Hansen TF, Hartmann AM, Hautzinger M, Heath AC, Henders AK, Herms S, Hickie IB, Hipolito M, Hoefels S, Holmans PA, Holsboer F, Hoogendijk WJ, Hottenga JJ, Hultman CM, Hus V, Ingason A, Ising M, Jamain S, Jones EG, Jones I, Jones L, Tzeng JY, Kähler AK, Kahn RS, Kandaswamy R, Keller MC, Kennedy JL, Kenny E, Kent L, Kim Y, Kirov GK, Klauck SM, Klei L, Knowles JA, Kohli MA, Koller DL, Konte B, Korszun A, Krabbendam L, Krasucki R, Kuntsi J, Kwan P, Landén M, Långström N, Lathrop M, Lawrence J, Lawson WB, Leboyer M, Ledbetter DH, Lee PH, Lencz T, Lesch KP, Levinson DF, Lewis CM, Li J, Lichtenstein P, Lieberman JA, Lin DY, Linszen DH, Liu C, Lohoff FW, Loo SK, Lord C, Lowe JK, Lucae S, MacIntyre DJ, Madden PA, Maestrini E, Magnusson PK, Mahon PB, Maier W, Malhotra AK, Mane SM, Martin CL, Martin NG, Mattheisen M, Matthews K, Mattingsdal M, McCarroll SA, McGhee KA, McGough JJ, McGrath PJ, McGuffin P, McInnis MG, McIntosh A, McKinney R, McLean AW, McMahon FJ, McMahon WM, McQuillin A, Medeiros H, Medland SE, Meier S, Melle I, Meng F, Meyer J, Middeldorp CM, Middleton L, Milanova V, Miranda A, Monaco AP, Montgomery GW, Moran JL, Moreno-De-Luca D, Morken G, Morris DW, Morrow EM, Moskvina V, Muglia P, Mühleisen TW, Muir WJ, Müller-Myhsok B, Murtha M, Myers RM, Myin-Germeys I, Neale MC, Nelson SF, Nievergelt CM, Nikolov I, Nimgaonkar V, Nolen WA, Nöthen MM, Nurnberger JI, Nwulia EA, Nyholt DR, O'Dushlaine C, Oades RD, Olincy A, Oliveira G, Olsen L, Ophoff RA, Osby U, Owen MJ, Palotie A, Parr JR, Paterson AD, Pato CN, Pato MT, Penninx BW, Pergadia ML, Pericak-Vance MA, Pickard BS, Pimm J, Piven J, Posthuma D, Potash JB, Poustka F, Propping P, Puri V, Quested DJ, Quinn EM, Ramos-Quiroga JA, Rasmussen HB, Raychaudhuri S, Rehnström K, Reif A, Ribasés M, Rice JP, Rietschel M, Roeder K, Roeyers H, Rossin L, Rothenberger A, Rouleau G, Ruderfer D, Rujescu D, Sanders AR, Sanders SJ, Santangelo SL, Sergeant JA, Schachar R, Schalling M, Schatzberg AF, Scheftner WA, Schellenberg GD, Scherer SW, Schork NJ, Schulze TG, Schumacher J, Schwarz M, Scolnick E, Scott LJ, Shi J, Shilling PD, Shyn SI, Silverman JM, Slager SL, Smalley SL, Smit JH, Smith EN, Sonuga-Barke EJ, St Clair D, State M, Steffens M, Steinhausen HC, Strauss JS, Strohmaier J, Stroup TS, Sutcliffe JS, Szatmari P, Szelinger S, Thirumalai S, Thompson RC, Todorov AA, Tozzi F, Treutlein J, Uhr M, van den Oord EJ, Van Grootheest G, Van Os J, Vicente AM, Vieland VJ, Vincent JB, Visscher PM, Walsh CA, Wassink TH, Watson SJ, Weissman MM, Werge T, Wienker TF, Wijsman EM, Willemsen G, Williams N, Willsey AJ, Witt SH, Xu W, Young AH, Yu TW, Zammit S, Zandi PP, Zhang P, Zitman FG, Zöllner S, Devlin B, Kelsoe JR, Sklar P, Daly MJ, O'Donovan MC, Craddock N, Sullivan PF, Smoller JW, Kendler KS, Wray NR; International Inflammatory Bowel Disease Genetics Consortium (IIBDGC). Genetic relationship between five psychiatric disorders estimated from genome-wide SNPs. Nat Genet. 2013 Sep;45(9):984-94. doi: 10.1038/ng.2711. Epub 2013 Aug 11.

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Responsible Party: Chen Li, Vice Director, Professor, Children's Hospital of Chongqing Medical University
ClinicalTrials.gov Identifier: NCT04017286     History of Changes
Other Study ID Numbers: CLi
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 25, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data is confidential during the study.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Chen Li, Children's Hospital of Chongqing Medical University:
Developmental assessment
Homocysteine
physique growth
nutrients

Additional relevant MeSH terms:
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Problem Behavior
Behavioral Symptoms
Nutrients
Growth Substances
Physiological Effects of Drugs