Prenatal Exposure Effects Psychophysiology Study

NCT ID: NCT01134770

Last Updated: 2024-12-18

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2025-06-30

Brief Summary

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

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.

Conditions

Pregnancy

Keywords

Prenatal Substance Use; Cocaine; Cigarette Smoking; Mothers; Pregnant women; Smoking Mothers

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Prenatal Cocaine

Use of cocaine at anytime during pregnancy. Subjects may also have used other drugs in combination with Cocaine

No interventions assigned to this group

Prenatal Nicotine-Alcohol-Marijuana

Subjects may have used any of these drugs during pregnancy, alone or in combination. This group has not used cocaine during pregnancy.

No interventions assigned to this group

Drug-Free Pregnancy

Subjects did not use any of the following drugs during pregnancy:

cocaine, nicotine, alcohol, marijuana.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Karen Grewen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

Other Identifiers

08-1092

Identifier Type: -

Identifier Source: org_study_id