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A Pilot Study of Prophylactic Management of Lamotrigine in Pregnant Women

NCT03774641 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2025-03-05

No results posted yet for this study

Summary

Pregnant women who are taking lamotrigine will be evaluated monthly during pregnancy including a clinical evaluation and a blood draw for lamotrigine levels at each visit. Based on the Therapeutic Drug Monitoring protocol, participant's lamotrigine dosing will be adjusted as needed based on participant's blood levels compared to the reference concentration that was obtained prior to pregnancy or early in pregnancy while clinically stable. After delivery participant and participant's infants will be assessed for mood and functioning at 1, 2, 4, and 6 weeks postpartum.

Conditions

Interventions

DRUG

Lamictal

Blood-serum levels will be checked monthly during pregnancy and reference concentration will be maintained

Sponsors & Collaborators

Principal Investigators

  • Lindsay Standeven, MD · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-03
Primary Completion
2024-04-16
Completion
2024-04-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03774641 on ClinicalTrials.gov