Fetal Neurobehavior in Non-methadone Maintained Women in Substance Abuse Treatment
Condition: Pregnancy; Drug Abuse
MeSH terms: Substance-Related Disorders
Study type: Observational

Summary: 
      This study seeks to elucidate fetal neurobehavioral development in fetuses of opioid
      dependent women who have either undergone and completed methadone detoxification,or who never
      received methadone maintenance, and are not methadone maintained at 36 weeks gestation. This
      research will determine how fetal neurobehavioral functioning in fetuses of opioid dependent,
      non-methadone maintained women differs from that of fetuses whose opioid dependent mothers
      are methadone maintained. The project will utilize a state-of-the-art computerized fetal
      actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart
      rate, the interaction between the two and maternal physiologic parameters.
    

Detailed description: 
      This project examines fetal neurobehavior in non-methadone maintained, opioid dependent
      women. Subjects are outpatients at the Center for Addiction and Pregnancy on the Johns
      Hopkins Bayview Medical Center campus, who are between the ages of 18 and 40, who have either
      completed a methadone detoxification prior to 32 weeks gestation and are on no opiate
      replacement therapy after 32 weeks gestation, or who have never received methadone
      maintenance, and are free of maternal or known fetal health complications. Women are
      consented at 32 weeks of gestation. During the four weeks between consent and fetal testing,
      women will be privately interviewed by project staff and administered the SCLR-90 (Symptom
      Checklist) ASRS (Adult ADHD Self-Report Scale), and the PSD (Posttraumatic Stress Diagnostic
      Scale). These tools will be used to detect symptoms in different psychological domains
      (SCLR-90), ADHD (ASRS) and PTSD (PSD). At 36 weeks of gestation, women undergo fetal
      monitoring. Maternal demographic data (i.e. substance use history, pregnancy history,
      methadone dose, other medications) are abstracted from the maternal chart prior to each
      session. Women are asked a series of questions (the SOWS, or Subjective Opiate Withdrawal
      Scale and Adjective Questionnaire), via standardized questionnaires used to detect the
      presence or absence of withdrawal symptomatology prior to each session. Women will undergo
      two 60 minute fetal monitoring sessions on this day. The timing of the two sessions is such
      that it will provide two historical control groups. The first session will occur at 9 AM. The
      second session will occur at 1 P.M. The use of two fetal testing times will alleviate the
      problem of fetal circadian rhythms which would otherwise confound one or the other groups.
      The data acquisition is performed using a standard fetal monitoring system (Toitu 325). Data
      recorded include fetal movements and fetal heart rate. Additional data to be recorded include
      maternal EKG via 3 electrodes placed on the maternal chest (right mid sub-clavicle, left
      mid-axillary thorax) and upper left thigh (for ground lead), maternal respirations via a
      bellows apparatus attached around the maternal chest beneath the breasts, maternal
      contractions via the same transducer that detects fetal movement and fetal heart rate, and
      maternal skin conductance, or electrodermal activity via two electrodes with a gelled skin
      contact area placed on the index and middle fingers of one hand affixed with adhesive collars
      to limit gel contact to a 1 cm circle, and velcro. This maternal data will be time
      synchronized and analyzed in conjunction with fetal data. Also planned is the observation of
      fetal response to externally applied sound (a baby rattle). At the conclusion of the 60
      minute session, an additional 6 minute recording will be added, with three sound stimuli at 1
      minute intervals. Infants will undergo neurobehavioral testing on day #3 of life. This
      testing consists of the administration of the NICU Network Neurobehavioral Scale (the NNNS),
      a standardized 30-minute harmless and painless evaluation of the infant's motor, sensory and
      neurologic capabilities. The exam evaluates the infant's responses to auditory and visual
      stimuli, as well as movement, reflexes, signs of stress and consolability. Infants will also
      undergo an assessment for vagal tone on the first and third days of life. This assessment
      will involve obtaining 8-10 minutes of resting heart rate via 3 standard infant EKG leads
      while the infant is in a quiet state. The EKG leads will be connected directly to a
      Physio-control EKG monitor (R wave Medical Electronics of Florida). This reading is then
      transmitted to a vagal tone monitor (Delta Biometrics, Inc.) and computer for data storage
      and off-line analysis. Software will be used to computer heart period and vagal tone
      measures.

      All fetal testing procedures obtained as part of this protocol are experimental; none are
      used for clinical purposes. Women consenting to participation will continue to receive
      routine care at CAP. Participants will be removed from the protocol if they should relapse to
      any licit or illicit substance between the time of consent (32 weeks gestation) and the time
      of fetal testing (36 weeks gestation).
    

Intervention name(s): Maternal fetal monitoring
Intervention type(s): Device
Intervention description(s): Simultaneous monitoring of maternal and fetal physiology
Other intervention name(s): Toitu 325
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        OPioid exposed pregnancies
      
Keywords: Fetus; Drug abuse; Fetal development; Substance abuse; Opioids; Methadone