An observational study in Epilepsy and Pregnancy, sponsored by Stanford University. Completed at 20 sites in United States. Open to female participants aged 14 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-13.
Sponsored by Stanford University · Observational
Epilepsy is one of the most common neurological disorders affecting women of childbearing age. Poor pregnancy outcomes are increased in these women and their children. The proposed studies will increase our knowledge on multiple levels to improve care and reduce adverse outcomes in these mothers and children. An overall goal of this study is to establish the relationship between antiepileptic drug exposure and outcomes in the mother and child as well as describe and explain the variability in antiepileptic drug exposure and response.
There is a compelling need for prospective, properly controlled studies in women with epilepsy (WWE) during pregnancy to improve maternal and child outcomes. The proposed investigations are pertinent to the National Institute of Neurological Disorders and Stroke Epilepsy Research Benchmarks and will address multiple gaps in our knowledge noted by the recent American Academy of Neurology guidelines. This multicenter investigation will employ a prospective, observational, parallel-group, cohort design with an established research team.
The specific aims are to:
An overall goal of the proposed research is to establish the relationship between antiepileptic drug exposure and outcomes in the mother and child as well as describe and explain the variability in antiepileptic drug exposure and response.
Anticonvulsant blood levels (ABLs) and area-under-the-concentration-time-curves (AUCs) will be used as direct measures of drug exposure. The results will enable clinicians to prospectively calculate individual dosing regimens for the mother in order to optimize dosing and limit unnecessary drug exposure to the child. In addition, genetic samples will be collected, which will provide a valuable resource for future pharmacogenetics studies to further delineate individual variability across patients.
FACTORS ASSESSED IN MONEAD.
Maternal factors: IQ, age, education, employment, ethnic group, maternal and family medical history including prior pregnancies and psychiatric disorders, socioeconomic status, site, periconception and pregnancy folate, concomitant medications, alcohol use, tobacco use, or other drug use during pregnancy, unwanted pregnancy, pregnancy complications, medical diseases and serious adverse events, McMaster Family Assessment Device (FAD), Block Food Frequency, and for WWE: types and frequency of seizures or epilepsy, antiepileptic drug dosages \& blood levels, and compliance.
Depression during pregnancy and post-partum as determined by the screening instrument (Beck Depression Inventory-II; BDI-II), the EPDS (Edinburgh Postnatal Depression Scale) and confirmed by the Structured Clinical Interview for DSM-IV (SCID), Beck Anxiety Inventory (BAI), Pittsburgh Sleep Index, and Perceived Stress Scale in mothers, Parental Stress Index, and Neurological Disorders Depression Inventory in Epilepsy (NDDI-E).
Maternal hormones (estradiol, progesterone) and Vit D will be drawn at Visit 1, 2, 3, 4, 5, 6 and 7. Maternal continine Levels will be collected via urine sample at Visit 3 on all non-smoking mothers. If the continine result is positive for tobacco smoke exposure, an LC/MS (liquid chromatography/mass spectrometry test.
Paternal \& relative factors: In fathers and a primary maternal relative, the following were collected: head circumference, IQ estimates, socioeconomic status, dob, race, ethnicity, family history, and medical history. For the father, marital status, total household income, employment status. weight, height, and handedness were also collected.
Adult IQ Assessments:
Peabody Picture Vocabulary Test (PPVT), Wechsler's Adult Intelligence Scale (WAIS).
Child factors: enrollment \& birth gestational ages, birthweight, breastfeeding, AED levels when breastfeeding, physical examinations, childhood medical diseases (including congenital malformations), head circumference, weight, serious adverse events, developmental delays, and special education. Also, obtained premature delivery, APGARs (1 \& 5 minutes), Neonatal Intensive Care Unit admissions and all admissions >12hrs, hypoglycemia (\<45), need for resuscitation, and neonatal death. Child Hgb, Hct, PKU, TSH, and T4 at delivery from med records if collected.
Child Cognitive/Behavioral Assessments:
Denver II, Behavior Assessment System for Children - Parent (BASCP-2) and Teacher (BASCT-2), Behavior Rating Inventory of Executive Functioning Preschool (BRIEFP) and version 2 (BRIEF-2), Adaptive Behavior Assessment Scale 3 (ABAS-3), Modified Checklist for Autism in Toddlers (M-CHAT), Modified Edinburgh Handedness Inventory, Gilliam Autism Rating Scale 3 (GARS-3), Bayley Scales of Infant and Toddler Development-3 (BSID-III), Differential Abilities Scale-II (DAS-II), Preschool Language Scale-5 (PLS-5), Peabody Picture Vocabulary Test-4 (PPVT-4), Beery-Buktenica Developmental Test of Visual-Motor Integration-6 (VMI-6), Torrance Test of Creative Thinking- Figural (TTCT-F), NEuroPSYchological Assessment 2nd edition (NEPSY2), Expressive One Word Picture Vocabulary Test-4 (EOWPVT4), Wechsler's Intelligence Scale for Children 5 (WISC5) Coding subtest, Children's Memory Scale (CMS), Lafayette Grooved Pegboard (GPB), Wide Range Achievement Test 5th edition (WRAT5), and Social Responsiveness Scale 2
Verbal intellectual ability at age 6 years is the ultimate primary outcome. It is determined by Verbal Index which is average of Word Definitions and Verbal Similarities subtests from the Differential Ability Scales-2nd ed. (DAS-II),50 -School Age Level, Expressive One-Word Picture Vocabulary Test-4,51 the Phonological Processing, Comprehension of Instructions and Sentence Repetition subscales from the NEPSY-2 57 and the Peabody Picture Vocabulary Test-4th ed. (PPVT-4).52 Children will not reach age 6 in this initial grant period, so primary outcome at age 2 will be the Language Scale from the Bayley Scales of Infant \& Toddler Development-III.
Cerebral Lateralization will be assessed as verbal minus non-verbal difference scores and proportion of dextrals in PWWE vs. HPW and in their children as assessed by the Edinburgh Handedness Inventory.
1,842 studies on the registry are indexed under Epilepsy; 423 are open to participants now.
This study's enrollment of 565 is above the median of 101 across 536 observational studies indexed under Epilepsy.
Browse Epilepsy studies →Stanford University is the lead sponsor of 2,161 studies on the registry; 428 are open to participants now.
Of its 268 completed or terminated interventional studies of FDA-regulated products, 207 (77%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects will be recruited by the investigators from their clinic populations and advertisements.
Inclusion Criteria for All Women
Inclusion Criteria applicable for pregnant women only. -Ability for follow-up through 6 years after giving birth.
Criteria applicable for non-pregnant women with epilepsy only:
Exclusion Criteria for All Women
Exclusion criteria applicable for pregnant women only.
Exclusion criteria applicable for all women with epilepsy.
-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. -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.
Inclusion Criteria for Study Family Members
The Maternal Relative must be a full biological relative or half-sibling of the mother chosen by the following hierarchy:
th Half-Sibling if NO Primary FULL relatives are available.
Exclusion Criteria for Study Family Members
Women in their first trimester of pregnancy who are not diagnosed with epilepsy
Women diagnosed with epilepsy and not currently pregnant.
Women in their first trimester of pregnancy and diagnosed with epilepsy
Change in seizure frequency over pregnancy vs. post-partum (comparable time periods for non-pregnant women with epilepsy).
Change in seizure frequency during pregnancy vs postpartum as measured by subject completed daily electronic seizure diaries
Time frame: Pregnant women with epilepsy:1st Trimester through 9 months post-partum; Nonpregnant women with epilepsy: Study enrollment through 18 months participation
C-section Rate
rate of C-sections in pregnant women without epilepsy vs pregnant women with epilepsy
Time frame: Pregnant women with epilepsy & Pregnant women without epilepsy at child's birth
Rate of Depression
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.
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
Child Intellectual Ability (2YO)
Child intellectual ability as measured by the Language Scale of the Bayley Scales of Infant Development -III at visit 9 (2YO). All of the outcome measures for cognitive outcomes at the various ages are scale scores which are continuous with a mean of 100 and a standard deviation of 15.
Time frame: When child is 2 Years of age
Child Intellectual Ability (4.5 YO)
Child intellectual ability as measured by the Torrence Test of Creative Thinking at visit 11 (4.5YO). All of the outcome measures for cognitive outcomes at the various ages are scale scores which are continuous with a mean of 100 and a standard deviation of 15.
Time frame: When child is 4.5 Years of age
Child Intellectual Ability (3 and 6 YO)
Child intellectual ability as measured by the Verbal Index Score at visit 10 (3YO) and visit 12 (6YO). All of the outcome measures for cognitive outcomes at the various ages are scale scores which are continuous with a mean of 100 and a standard deviation of 15.
Time frame: When child is 3 and 6 Years of age
Small for Gestational Age Rate
Rate of children considered small for gestational age (\<10%tile)born to women with epilepsy vs women without epilepsy
Time frame: Child's birth
Breastfeeding Effects on verbal intellectual ability in children
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.
Time frame: Birth until the child is 2 Years of age, although we anticipate not all children will breastfeed until 2 Years
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