Prenatal Exposure Effects Psychophysiology Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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): cocaine nicotine (cigarettes) marijuana 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: 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. 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.

Official Title
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Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction

Conditions
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Pregnancy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prenatal Cocaine<br>Use of cocaine at anytime during pregnancy. Subjects may also have used other drugs in combination with Cocaine | |
| Prenatal Nicotine-Alcohol-Marijuana<br>Subjects may have used any of these drugs during pregnancy, alone or in combination. This group has not used cocaine during pregnancy. | |
| Drug-Free Pregnancy<br>Subjects did not use any of the following drugs during pregnancy: cocaine, nicotine, alcohol, marijuana. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes |  | 2 to 4 weeks of age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prenatal Substance Use, Cocaine, Cigarette Smoking, Mothers, Pregnant women, Smoking Mothers