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Clinical Trials/ISRCTN98260309
ISRCTN98260309
Completed
Not Applicable

eurodevelopment of Babies Born to Mothers with Epilepsy (NaME): a observational cohort study

The University of Manchester0 sites385 target enrollmentApril 26, 2016
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ConditionsSpecialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicineUKCRC code/ Disease:Pregnancy and Childbirth

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Specialty: Reproductive health and childbirth, Primary sub-specialty: Reproductive and sexual medicine
Sponsor
The University of Manchester
Enrollment
385
Status
Completed
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 26, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\. A diagnosis of epilepsy and either:
  • •1\.1\. On antiepileptic drug treatment (experimental group)
  • •1\.2\. Not on treatment (control group)
  • •2\. Living within the North West, North East of England or Northern Ireland.
  • •3\. Able to provide informed consent
  • •4\. In their first or second trimester of pregnancy

Exclusion Criteria

  • •1\. Significant learning disability (defined as not able to live independently).
  • •2\. Taking non\-AED medications which are known to be teratogenic (e.g. warfarin)
  • •3\. Unable to understand written or verbal English (due to the standardised assessments in use)

Outcomes

Primary Outcomes

Not specified

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