Prenatal Exposure Effects Psychophysiology Study



Status:Enrolling by invitation
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 45
Updated:10/14/2018
Start Date:July 2008
End Date:June 2019

Use our guide to learn which trials are right for you!

Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction

The purpose of the study is to understand the biology and behavior of early mother-infant
attachment, and to investigate how it may be affected by prenatal substance exposures. The
investigators are interested in how drugs such as cocaine, alcohol, marijuana and cigarette
smoking affect both mother and baby.

The investigators are looking for pregnant women or mothers with their newborn infants to
participate in this study. Eligible women include mothers who have used any of the following
drugs at any time during pregnancy (alone or in combination):

1. cocaine

2. nicotine (cigarettes)

3. marijuana

4. alcohol

The investigators are also looking for mothers who have not used any drugs during pregnancy.

Information collected in this research study is strictly confidential, and protection of
sensitive information is additionally assured by an NIH Certificate of Confidentiality.

Participation in this study involves:

1. One visit at 2-4 weeks postpartum. This visit includes an interview for mother and a 30
minute brain scan (no radiation, no sedation) for baby.

2. Two visits at 3 months postpartum. Mothers will have blood pressure and heart rate
measured while they look at videos about babies, listen to baby sounds, interact with
their own baby. Samples of blood, urine and saliva will be taken from mother. Baby will
have a developmental assessment, and saliva samples will be taken.

Payment is $300 or the equivalent in Walmart gift cards for completion of brain imaging, lab
visits and 1 day of monitoring mother's blood pressure at home.

Inclusion Criteria:

- During pregnancy, mother has used any of the following:

- cocaine

- marijuana and/or alcohol but not cocaine

- nicotine (smoked cigarettes)

- no drugs during pregnancy

- Mother is pregnant or no more than 4 weeks postpartum

Exclusion Criteria:

- Mother has cardiovascular disease

- Delivery before 36 weeks or later than 42 weeks gestation

- Birth weight less than 5.5 lbs

- Baby was a multiple birth
We found this trial at
1
site
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials