Cardiovascular Effects of Prenatal Methamphetamine Exposure

University of California (UC) Davis

Status: Completed

Conditions: Newborn Complication | Patient | Neonatalology; Methamphetamine Abuse

Study type: Observational

Funder types: Other

Identifiers

NCT04616625

1632548

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

26 participants in 2 patient groups

Methamphetamine exposed

Description:

Infants born to mothers with prenatal history of MA use during current pregnancy and/or positive meconium toxicology positive for MA in infant.

Methamphetamine non-exposed

Description:

Infants born to mothers without prenatal history of MA use during this pregnancy and negative meconium toxicology for MA in infant.