Maternal and Neurodevelopmental Outcomes of in Utero Antiepileptic Drug (AED) Exposure (MONEAD)
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|ClinicalTrials.gov Identifier: NCT01730170|
Recruitment Status : Active, not recruiting
First Posted : November 21, 2012
Last Update Posted : October 14, 2020
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||565 participants|
|Official Title:||Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs|
|Actual Study Start Date :||January 2013|
|Estimated Primary Completion Date :||August 30, 2022|
|Estimated Study Completion Date :||February 28, 2023|
Pregnant Women without Epilepsy
Women in their first trimester of pregnancy who are not diagnosed with epilepsy
Nonpregnant Women with Epilepsy
Women diagnosed with epilepsy and not currently pregnant.
Pregnant Women with Epilepsy
Women in their first trimester of pregnancy and diagnosed with epilepsy
- Increase in seizure frequency over pregnancy vs. post-partum (comparable time periods for non-pregnant women with epilepsy). [ Time Frame: Pregnant women with epilepsy:1st Trimester through 9 months post-partum; Nonpregnant women with epilepsy: Study enrollment through 18 months participation ]Increase in seizure frequency during pregnancy vs postpartum as measured by subject completed daily electronic seizure diaries
- C-section Rate [ Time Frame: Pregnant women with epilepsy & Pregnant women without epilepsy at child's birth ]rate of C-sections in pregnant women without epilepsy vs pregnant women with epilepsy
- Rate of Depression [ Time Frame: Pregnant women: 1st Trimester through 9 months post partum, again when child is 2 and 3 Years of age. Nonpregnant women with epilepsy: Study enrollment through 6months participation, then 12 months until 18 months participation ]Rate of depression during pregnancy in pregnant women with epilepsy vs pregnant women without epilepsy screened by the Beck Depression Inventory and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual-IV.
- Child Verbal Intellectual Ability [ Time Frame: When child is 2, 3, 4.5 and 6 Years of age ]Child verbal intellectual ability as measured by the Language Scale of the Bayley Scales of Infant Development -III at visit 9 (2Yo) and by the Differential Abilities Scale-II at visit 10 (3Yo)and 4.5YO and 6YO.
- Small for Gestational Age Rate [ Time Frame: Child's birth ]Rate of children considered small for gestational age (<10%tile)born to women with epilepsy vs women without epilepsy
- Breastfeeding Effects on verbal intellectual ability in children [ Time Frame: Birth until the child is 2 Years of age, although we anticipate not all children will breastfeed until 2 Years ]Measuring difference in verbal intellectual ability in breastfed children vs non-breastfed children born to women on aeds via the Bayley Scales of Infant Development III Language scale at 2 years of age and Differential Abilities Scale III at 3, 4.5 and 6 Years of age.
Biospecimen Retention: Samples With DNA
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): NCT01730170
|Principal Investigator:||Kimford J Meador, M.D.||Emory University|
|Principal Investigator:||Page B Pennell, M.D.||Brigham & Women's Hospital - Harvard|