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.

Study Overview

• Status: Recruiting
• Conditions: Methamphetamine Abuse; Newborn Complication | Patient | Neonatalology

• Study Type: Observational
• Enrollment (Anticipated): 42

Contacts and Locations

• Study Contact: Name: Deepika Sankaran, MD; Phone Number: 3477410372; Email: dsankaran@ucdavis.edu
• Study Contact Backup: Name: Satyan Lakshminrusimha, MD; Phone Number: 9167343891; Email: slakshmi@ucdavis.edu

Study Locations

• United States
  • California
    • Marysville, California, United States, 95901
      • Recruiting
      • Adventist Health and Rideout
      • Contact: Deepika Sankaran, MD; Phone Number: 916-734-8672; Email: dsankaran@ucdavis.edu
      • Contact: Rosa R. Pesavento; Phone Number: 6508145023; Email: rpesavento@ucdavis.edu
    • Sacramento, California, United States, 95817
      • Not yet recruiting
      • UC Davis Children's Hospital
      • Contact: Rosa R. Pesavento; Phone Number: 650-814-5023; Email: rpesavento@ucdavis.edu
      • Contact: Catherine Rottkamp, MD PhD; Phone Number: 9168165077; Email: carrottkamp@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Infants born at UCDCH and at AHRO at gestational age >34 weeks. (<34 weeks excluded to avoid the effects of prematurity)

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Methamphetamine exposed; 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; Infants born to mothers without prenatal history of MA use during this pregnancy and negative meconium toxicology for MA in infant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of prevalence of MA use among births		Through study completion, an average of 2 years.
Evaluation of effects of prenatal MA exposure on neonatal cardiovascular status.	Perfusion index by pulse-oximeter, heart function by echocardiogram, EKG and detailed cardiac exam in the newborn period between 24-48 hours after birth.	Through study completion, an average of 2 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Infant's neurodevelopmental outcome and general assessment at 12 months of age.	Phone call with parent to assess the infant's neurodevelopment at 12 months of age using "Ages and Stages" questionnaire with parent and/or pediatrician, assessment of general health, nutrition and cardiovascular status (BP measurement) by phone call with pediatrician	Through study completion, an average of 2 years.

Collaborators and Investigators

• Sponsor: University of California, Davis
• Collaborators: Adventist Health and Rideout

Publications and helpful links

Helpful Links

• Learn more or sign up for the study here!

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: October 8, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Methamphetamine; Methamphetamine in pregnancy; Cardiovascular effects of methamphetamine on newborn; Effect of prenatal methamphetamine exposure on neurodevelopment
• Other Study ID Numbers: 1632548

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No