[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fetal-alcohol-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fetal-alcohol-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100314295","in-utero-alcoholic-exposure-plgf-biomarker-of-fetal-brain-lesions-100314295",false,"NCT03371641","In Utero Alcoholic Exposure: PlGF, Biomarker of Fetal Brain Lesions","ALCOBRAIN","Inclusion Criteria:\n\nMother:\n\n* Pregnant woman (monofetal or twin pregnancy, whatever the parity)\n* Age\\> or = to 18 years\n* Person affiliated to a social security system\n* Person who read and understood the information form and signed the consent form\n\n  * Alcohol exposure group Chronic consumption of at least 30 g of alcohol per week or acute consumption of \"binge drinking\" type during pregnancy (knowing that a unit of 10 g of pure alcohol corresponds to 25 cl of beer 4 ° 5, 10 cl of wine at 12 °, 3 cl of whiskey, 7 cl of Porto ...)\n  * Control group No alcohol consumption during pregnancy\n  * Child Informed parents and written consent signed by the father and mother for the child's participation in this research (unless one of the parents does not have parental authority)\n\nExclusion Criteria:\n\n* Female under 18\n* Pregnant woman with clinical suspicion of pre-eclampsia and \u002F or HELLP syndrome\n* Person deprived of liberty by an administrative or judicial decision or protected major subject (under tutorship or curatorship)\n* Patient participating in another interventional trial or who participated in another interventional trial during pregnancy",true,"FEMALE","18 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to validate that PLGF is a biomarker of cerebral lesions and therefore of secondary developmental disorders and disabilities that will be best diagnosed at 2 and 6 years of age.",[27],"Fetal Alcohol Syndrome",[27,29,30,31,32,33],"Pregnancy","Biomarker","PlGF","Cognitive development","Behavior troubles","RECRUITING","2026-02-04",{"date":37,"type":38},"2026-02-06","ACTUAL",{"date":40,"type":38},"2017-01-27",{"date":42,"type":21},"2026-03-27",{"name":44,"class":45},"University Hospital, Rouen","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":54,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":46},"100392836","phase-2-rct-of-prenatal-choline-supplementation-during-pregnancy-to-mitigate-adverse-effects-of-prenatal-alcohol-exposure-100392836","NCT04395196","RCT of Prenatal Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure","A Randomized, Double-Blind, Placebo-controlled Clinical Trial of Choline Supplementation During Pregnancy to Mitigate Adverse Effects of Prenatal Alcohol Exposure on Growth and Cognitive Development","Inclusion Criteria:\n\n* Age ≥18 yr\n* ≤20 wk gestation\n* Singleton pregnancy\n* Currently heavy drinking (average of ≥15 ml AA\u002Fday or binge drinking (≥4 standard drinks\u002Foccasion) on at least 1.5 occasions\u002Fmonth on average since becoming pregnant)\n* Current choline dietary intake \\\u003C1 g\u002Fday\n* Language fluency in English or Afrikaans\n\nExclusion Criteria:\n\n* Use of methamphetamine or other illicit drugs other than marijuana during the past year\n* HIV positive\n* Pharmacologic treatment for a serious pre-existing medical condition (e.g., diabetes, hypertension, epilepsy, or cardiac problems)\n* Having another child enrolled in the trial from a previous pregnancy\n* Plans for mother or child to move away from the area prior to study completion","ALL","45 Years",{"count":57,"type":21},288,[59],"PHASE2","Although the adverse effects associated with prenatal alcohol exposure (PAE) are well known, many women continue to drink heavily during pregnancy, putting their infants at risk for fetal alcohol spectrum disorders. Animal studies have shown that choline supplementation can mitigate effects of PAE on growth and development. Choline, an essential nutrient, serves as a methyl-group donor for DNA methylation and is a constituent of the neurotransmitter acetylcholine and a precursor to major components of cell membranes. In an R21 feasibility trial, 70 heavy drinkers were randomly assigned to receive a daily dose of 2g of choline or a placebo from initiation of antenatal care to delivery in Cape Town, South Africa, where the incidence of heavy drinking during pregnancy and fetal alcohol syndrome are among the highest in the world. When compared with infants in the placebo arm, infants in the choline-treated arm were more likely to meet criterion for eyeblink conditioning, demonstrated markedly better recognition memory on the Fagan Test of Infant Intelligence, which is known to have predictive validity for school-age IQ, and had better postnatal gains in weight and head circumference. Key features of this study included the higher choline dose (4.4 times adequate intake (AI), compared to 1.7-2.5 in previous human studies) and initiation of treatment early in pregnancy. We are now conducting a fully-powered, double-blind, randomized, placebo-controlled choline supplementation trial in heavy drinking pregnant women from a rural community in South Africa (1) to assess the effectiveness of maternal choline supplementation during pregnancy to mitigate effects of PAE on three primary outcomes: infant recognition memory and postnatal growth restriction (weight and head circumference); (2) to assess the efficacy of this supplementation for mitigating alcohol effects on the following secondary outcomes: infant eyeblink conditioning, postnatal length, and information processing speed; (3) to use innovative methods in causal inference analysis to examine protocol adherence as an important source of variation in treatment efficacy and to identify sociodemographic factors associated with non-compliance in order to facilitate implementation of the intervention protocol in clinical settings; and (4) in exploratory analyses, to examine whether maternal choline supplementation is particularly effective in women with lower dietary choline intake or poor nutritional status.",[62,27],"Fetal Alcohol Spectrum Disorders",[64,65,66,67],"Prenatal Alcohol Exposure","Choline Supplementation","Infant Neurodevelopment","Growth","2025-03-25",{"date":70,"type":38},"2025-04-01",{"date":72,"type":38},"2023-04-13",{"date":74,"type":21},"2028-05-15",{"name":76,"class":45},"Wayne State University",{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":104,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100480329","the-oklahoma-parent-child-assistance-program-100480329","NCT05534568","The Oklahoma Parent-Child Assistance Program","A Randomized Controlled Trial of the Parent-Child Assistance Program in Oklahoma","Inclusion Criteria:\n\n* 18 years or older\n* Women who have used alcohol, opioids, or other drugs during pregnancy\n* Women who are (1) pregnant or have a child under 24 months old who was exposed to substances and are not well connected to community services or (2) have a child with fetal Alcohol Spectrum Disorder and are currently with at-risk alcohol use and in childbearing years\n* Resides in Oklahoma City, Oklahoma or Tulsa, Oklahoma\n\nExclusion Criteria:\n\n* Not meeting eligible criteria above\n* Incarcerated at the time of enrollment\n* Enrollment in similar services (i.e., ReMerge, Systems of Care (SOC) and\u002For Family Treatment Courts (FTC) and heading to Termination of Parental Rights (TPR))\n* If the participant is receiving services from the Substance use Treatment and Recovery (STAR) Prenatal Clinic and is part of the research, their enrollment in PCAP will be delayed until STAR Prenatal Clinic graduation",{"count":85,"type":21},200,[24],"The Parent-Child Assistance Program (PCAP) helps mothers who have used alcohol, opioids, or other drugs during pregnancy and their children through the work of highly trained, closely supervised case managers. Case managers work closely with mothers over the course of three years, meeting the mothers in their own homes when possible, to help them to set goals and take advantage of available resources. The primary aims of PCAP include: (1) assisting mothers in obtaining substance use disorder (SUD) treatment and staying in recovery, (2) linking mothers to community resources that will help them build and maintain healthy, independent family lives for themselves and their children, and (3) preventing future drug and alcohol use during pregnancy.\n\nThis study brings PCAP to Oklahoma (the state with the highest incarceration rate for women, where most enter the criminal justice system for drug charges) for the first time. This five-year project includes 200 women who will enroll in the study and be randomly assigned to the treatment (100 women) or control group (100 women). The intervention (i.e., PCAP services) will take place over a three-year period at two sites: Oklahoma City, Oklahoma and Tulsa, Oklahoma.\n\nThis evaluation will measure participants' substance use, substance use disorder (SUD) treatment outcomes, and a host of other well-being outcomes-including but not limited to subsequent substance-exposed births, use of public assistance, education, use of family planning methods, and employment-to evaluate the effects of PCAP services. Among these, the investigators have identified four key outcomes: (1) the mother is on a reliable method of birth control, (2) abstinence for six months, (3) child custody (i.e., placement of children in foster care and\u002For with kinship providers), and (4) criminal justice involvement.",[89,90,91,92,93,94,95,96,62,27,97,98,99,100,101,102,103],"Substance Use Disorders","Pregnancy Related","Alcohol Use Disorder (AUD)","Alcohol Use Complicating Pregnancy, First Trimester","Alcohol Use Complicating Pregnancy, Second Trimester","Alcohol Use Complicating Pregnancy, Third Trimester","Alcohol Use Complicating Pregnancy, Unspecified Trimester","Alcohol Use Complicating Pregnancy, Childbirth, and the Puerperium","Drug Use Disorders","Drug Use Complicating Pregnancy, First Trimester","Drug Use Complicating Pregnancy, Second Trimester","Drug Use Complicating Pregnancy, Third Trimester","Drug Use Complicating Pregnancy, Unspecified Trimester","Drug Use Complicating Pregnancy, Childbirth, and the Puerperium","Maternal Drugs Affecting Fetus",[105,106,107,108,109,110,111,112,113,114],"Parent-child assistance","Substance use disorder","addictions","drug dependence","drug abuse","alcohol dependence","alcohol abuse","alcoholism","recovery services","PCAP","2024-06-05",{"date":117,"type":38},"2024-06-07",{"date":119,"type":38},"2022-11-15",{"date":121,"type":21},"2026-11-15",{"name":123,"class":45},"University of Oklahoma",2]