| Conditions: |
|
Fetus - Embryology - Pregnancy - Drug Abuse |
| Purpose: |
|
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.
|
| Study Summary: |
|
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).
|
| Criteria: |
|
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
|
| NCT ID: |
|
NCT00522626 |
| Primary Contact: |
|
Principal Investigator
Lauren M Jansson, MD
Johns Hopkins University
Lauren M Jansson, MD
Phone: 410-550-5438
Email: ljansson@jhmi.edu
|
| Backup Contact: |
|
Email: ewilli77@jhmi.edu
Erica Williams
Phone: (410)550-8779
|
| Location Contact: |
|
Baltimore, Maryland 21224
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |