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Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy Clinical research trials and Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy medical trials happen in hundreds of localities throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy. Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy clinical trial. Participants frequently obtain the most expert healthcare available for their Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy  Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
For Condition: Cognition Disorders,Epilepsy,Seizure
Status: No longer recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: To determine if antiepileptic drugs (AEDs) differ in their neurodevelopmental effects. Specifically, do the children of the women with epilepsy differ in their behavioral and cognitive development depending on which AED their mother takes during pregnancy?
Details: This is a prospective investigation enrolling 285 to 380 women with epilepsy during the first two trimesters of their pregnancies. There are 25 clinical centers as well as the database center. The women will be taking one of the following AEDs: carbamazepine, phenytoin, valproate, or lamotrigine. Cognitive and behavioral testing of the child will be done up to the age of 6 years. The study does not change the woman's doctor and does not interfere with the care of the treating physician.
Eligibility:
Study Type: Observational, Natural History, Longitudinal, Defined Population, Prospective Study
Minimum Age/Maximum Age: /
Genders: Female
Protocol Entry Criteria: - Subject must be diagnosed with partial seizures and/or secondary generalization or primary generalized seizures (absence, atonic, myoclonic, and generalized tonic-clonic seizures) - Subjects must be on either carbamazepine, lamotrigine, phenytoin, or valproate monotherapy. - Mothers must not have a history of drug abuse (including alcohol) in the last year and have no sequelae of drug abuse. - Mothers must be able to maintain an accurate seizure diary of major motor seizures - Subjects must have an IQ greater than or equal to 70 points. - Subjects must have a history of a negative RPR and HIV. - Subjects must not have progressive cerebral disease or presence of other major medical illness - Subjects must not have exposure to known teratogens during pregnancy, except AEDs. - Subjects must not have poor compliance with prenatal care. - Subjects must have adequate reading skills to perform the cognitive tests.
Total Enrollment: 380
Location and Contact Information:
Overall Study Official:
KimfordMeador, Principal Investigator, Georgetown University
Georgetown University
Charleston, South Carolina, 29414
United States
Additional Information:
Study ID Numbers: R01NS038455;
Study Start Date: September 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00021866
Other Seizure Studies:
1. Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
Related Studies:
Other Seizure Clinical Trials
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Developmental Effects On Children Of Women Who Take Antiepileptic Drugs During Pregnancy
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