The National Institute of Neurological Disorders and Stroke, part of the National Institutes of Health, is looking for individuals to participate in clinical studies. Participating in clinical trials allows you to play an active role in research on the nature and causes of many disorders of the brain and nervous system, and to possibly help physician-scientists develop future treatments. The information below is designed to help you quickly learn about actively recruiting research studies for which you or someone you know may be eligible.
The purpose of this study is to discover how antiepileptic drugs (AED) affect pregnancy outcomes for both the mother and child, including obstetrical complications, seizures, and the long-term effects of AED on children.
AED often are used to help control seizures in women with epilepsy. Many cannot stop taking these medications even if they become pregnant. During pregnancy, the doses of medications may be changed to keep seizures under control. However, the effects of these medications and the different dosages on pregnancy and on unborn children and their development are not fully known.
The goal of the MONEAD study is to determine how AED (including different dosages) affect pregnancy and the long-term effects these medications have on the mothers and children including the children’s behavior and thinking abilities. Exposure to anti-seizure medications through the womb as well as through breast milk will be considered. The differences in the effects of the medications and different doses, and problems during pregnancy and birth as well as the children’s family history and environment also will be considered.
1. Pregnant women with epilepsy up to 20 weeks gestation, healthy pregnant women without epilepsy up to 20 weeks gestation, or non-pregnant women with epilepsy.
2. Ability to maintain a daily medical diary.
3. Access to a telephone for phone contacts.
4. Age 14-45 inclusive.
5. Ability for follow-up through 6 years after giving birth. Criteria applicable for pregnant women only.
6. Minimum of 9 months post-partum. Criteria applicable for non-pregnant women with epilepsy only.
7. Not currently breastfeeding. Criteria applicable for non-pregnant women with epilepsy only.
8. Language skills in English or Spanish adequate to perform the cognitive tests and questionnaires.
1. Women with an expected IQ<70.
2. IV drug use in past year or any of the following since the beginning of pregnancy: Alcohol abuse, cocaine, or methamphetamine) or sequelae of drug/alcohol abuse.
3. History of psychogenic non-epileptic spells.
4. History of positive Syphilis test.
5. History of HIV positive test.
6. Progressive cerebral disease (e.g., multiple sclerosis, progressive brain tumor).
7. Presence of other major medical illness (e.g., diabetes, cancer).
8. Any medical, psychiatric, or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs ability to give informed consent.
9. Concurrent participation in an experimental drug trial
10. Exposure to known teratogens during pregnancy, excluding AEDs. Please see the MOP for an updated list of known teratogens. Exclusion criteria applicable for pregnant women only.
11. Detection of fetal major congenital malformation prior to enrollment in current pregnancy.
12. History of a known genetic disorder in herself or a primary relative (may contact MONEAD team with details for possible exception). Exclusion criteria applicable for pregnant women only.
13. Use of non-licensed midwife as primary source of natal care and/or planning home delivery or delivery at a stand-alone birth center, independent from a hospital.
14. Planned surgical intervention for epilepsy that would occur during the subject’s participation in the project
Exclusion criteria applicable for pregnant women with epilepsy only.
15. History of switching AEDs during pregnancy prior to enrollment. “Switching” AEDs includes changing from no AED therapy to therapy, discontinuing a current AED therapy, or changing to a different AED therapy.
Exclusion criteria applicable for non-pregnant women only.
16. Diagnosed by a health care professional as perimenopausal or postmenopausal.
17. History of switching AEDs within 90 days of enrollment. “Switching” AEDs includes changing from no AED therapy to therapy, discontinuing a current AED therapy, or changing to a different AED therapy. “
Inclusion Criteria for Study Family Members:
1. The Father must be the biological father of the child in the study.
2. The Maternal Relative must be a full biological relative of the mother chosen by the following hierarchy:
1st choice: Sister of closest age to the mother in the trial
2nd. Sister of next closest age
3rd. Brother of closest age
4th. Brother of next closest age
6th. Father of pregnant mother in the study.
Exclusion Criteria for Study Family Members:
1. Any medical, psychiatric, or other condition that, in the judgment of the investigator, is a contraindication to protocol participation or impairs ability to give informed consent.
Contact: Gene Moore, telephone: 843-261-4805; email: firstname.lastname@example.org; or Dominic Ippolito, telephone: 301-251-1161 ext. 125; email: email@example.com; or visit: http://clinicaltrials.gov/ct2/show/NCT01730170 or www.moneadstudy.org
Last Reviewed July 2, 2015