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Cardiovascular Effects of Prenatal Methamphetamine Exposure
Methamphetamine (MA) is one of the commonly used drugs during pregnancy. Cardiovascular effects of MA include elevated blood pressure, acute vasospasm, atherosclerotic disease, structural and electrical remodeling of cardiac tissue leading to arrhythmias and heart failure, and pulmonary hypertension.1 In addition, MA can cause neurotoxicity with harmful effects on neurodevelopment in the children who had prenatal exposure.5-8 Currently neonatal providers do not perform detailed cardiovascular evaluation in newborn period or long term neurodevelopmental assessments as outpatient for the newly born infants with prenatal exposure to MA, and they do not qualify for early intervention. The goal of the investigators is to perform detailed cardiovascular evaluation in neonatal period and estimate baseline prevalences and follow up with developmental and cardiovascular assessment using a questionnaire at 12 months in a cohort of neonates enriched with those who had prenatal exposure to MA.
Conditions:
🦠 Methamphetamine Abuse 🦠 Newborn Complication | Patient | Neonatalology
🗓️ Study Start (Actual) 5 October 2020
🗓️ Primary Completion (Estimated) 30 June 2023
✅ Study Completion (Estimated) 30 June 2023
👥 Enrollment (Estimated) 42
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Marysville, California, United States
📍 Sacramento, California, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Infants born at UCDCH and at AHRO at gestational age \>34 weeks. (\<34 weeks excluded to avoid the effects of prematurity)
    • 2. For the MA exposed subgroup (n=30): Infants born to mothers with prenatal history of MA use during current pregnancy and/or positive meconium toxicology positive for MA in infant.
    • 3. For the MA unexposed subgroup (n=12): Infants born to mothers without prenatal history of MA use during this pregnancy and negative meconium toxicology for MA in infant.

    Exclusion Criteria:

    • a) Presence of congenital anomalies and known fatal conditions.
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 8 October 2020
  • First Submitted that Met QC Criteria 29 October 2020
  • First Posted 5 November 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 28 November 2022
  • Last Update Posted 30 November 2022
  • Last Verified November 2022
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