Fetal Neurobehavior in Non-methadone Maintained Women in Substance Abuse Treatment

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).

Inclusion Criteria:

- Generally healthy women between ages 18 and 40, current clients of the CAP program

- Singleton, uncomplicated pregnancies, dated with routine 16 to 20 week ultrasound (as
is part of standard care at CAP)

- Abstinence from licit and illicit substance abuse in the four weeks prior to consent

Exclusion Criteria:

- Complications of pregnancy, including gestational diabetes, polyhydramnios,
hypertension, placenta previa or preterm labor

- Significant maternal health problems related to pregnancy, including HIV infection
and Type I diabetes

- Significant maternal psychopathology or other pathology that would preclude informed
consent (schizophrenia, mental retardation)

- Recent drug use, defined as positive urine toxicology (performed randomly at least
weekly in the treatment center), clinical positives (subject appearing intoxicated at
the treatment center) or patient report in the four weeks prior to recruitment, or at
any time during study participation (i.e. from 28 weeks to 36 weeks gestation)

- Recent alcohol use, by clinical detection, patient report or breathalyzer reading
(performed at the treatment center to confirm clinical impression) at any time in the
four weeks prior to recruitment, or at any time during study participation