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Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD) (MONEAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01730170
Recruitment Status : Completed
First Posted : November 21, 2012
Last Update Posted : July 13, 2023
Sponsor:
Collaborators:
The Emmes Company, LLC
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Kimford Jay Meador, Stanford University

Study Description
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Brief Summary:
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.

Condition or disease
Epilepsy Pregnancy

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Study Design
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Study Type : Observational
Actual Enrollment : 565 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs
Actual Study Start Date : January 2013
Actual Primary Completion Date : December 12, 2022
Actual Study Completion Date : December 12, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Pregnancy

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Change 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 ]
    Change in seizure frequency during pregnancy vs postpartum as measured by subject completed daily electronic seizure diaries

  2. 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

  3. 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.

  4. Child Intellectual Ability (2YO) [ Time Frame: When child is 2 Years of age ]
    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.

  5. Child Intellectual Ability (4.5 YO) [ Time Frame: When child is 4.5 Years of age ]
    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.

  6. Child Intellectual Ability (3 and 6 YO) [ Time Frame: When child is 3 and 6 Years of age ]
    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.

  7. 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

  8. 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
Serum, cheek cells, urine

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   14 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited by the investigators from their clinic populations and advertisements.
Criteria

Inclusion Criteria for All Women

  • 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.
  • Ability to maintain a daily medical diary.
  • Language skills in English or Spanish adequate to perform the cognitive tests and questionnaires.
  • Access to a telephone for phone contacts.
  • Age 14-45 inclusive.

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:

  • Minimum of 9 months post live birth, miscarriage, or elective termination.
  • Not currently breastfeeding.

Exclusion Criteria for All Women

  • Women with an expected IQ<70.
  • 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.
  • History of psychogenic non-epileptic spells.
  • History of positive Syphilis test.
  • History of HIV positive test.
  • Progressive cerebral disease (e.g., multiple sclerosis, progressive brain tumor).
  • Presence of other major medical illness (e.g., diabetes, cancer).
  • 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.
  • Concurrent participation in an experimental drug trial.

Exclusion criteria applicable for pregnant women only.

  • Exposure to known teratogens during pregnancy, excluding AEDs.
  • Detection of fetal major congenital malformation prior to enrollment in current pregnancy.
  • History of a known genetic disorder in herself or a primary relative (may contact MONEAD team with details for possible exception).
  • 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.

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.

  • Diagnosed by a health care professional as perimenopausal or postmenopausal.
  • 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

  • The Father must be the biological father of the child in the study.

  • The Maternal Relative must be a full biological relative or half-sibling of the mother chosen by the following hierarchy:

    1. st choice: Sister of closest age to the mother in the trial
    2. nd Sister of next closest age
    3. rd Brother of closest age
    4. th Brother of next closest age
    5. th Mother
    6. th Father of pregnant mother in the study

    7. th Half-Sibling if NO Primary FULL relatives are available.

      Exclusion Criteria for Study Family Members

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Stanford University
The Emmes Company, LLC
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Kimford J Meador, M.D. Stanford University
Principal Investigator: Page B Pennell, M.D. University of Pittsburgh
Principal Investigator: Abigail Matthews, PhD The Emmes Company, LLC
  Study Documents (Full-Text)

Documents provided by Kimford Jay Meador, Stanford University:
Study Protocol and Informed Consent Form  [PDF] November 17, 2021

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kimford Jay Meador, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT01730170    
Other Study ID Numbers: IRB00060793
2U01NS038455-11A1 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2012    Key Record Dates
Last Update Posted: July 13, 2023
Last Verified: July 2023
Keywords provided by Kimford Jay Meador, Stanford University:
Epilepsy
Pregnancy
Additional relevant MeSH terms:
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Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases