PregnancyPEEPSNCT01134770
Prenatal Exposure Effects Psychophysiology Study
An observational study of Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women or mothers with their newborn infants.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
Read the 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):
- 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.
- Conditions
- Pregnancy
- Keywords
- Prenatal Substance Use, Cocaine, Cigarette Smoking, Mothers, Pregnant women, Smoking Mothers
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prenatal Cocaine | Use of cocaine at anytime during pregnancy. Subjects may also have used other drugs in combination with Cocaine | |
| 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. | |
| Drug-Free Pregnancy | Subjects did not use any of the following drugs during pregnancy: cocaine, nicotine, alcohol, marijuana. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes
Measured: 2 to 4 weeks of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startJul 2008
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Grewen, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134770
- Sponsor's protocol ID
- 08-1092
- Acronym
- PEEPS
- Status last verified
- Feb 2026
- First submitted
- 28 May 2010
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prenatal Cocaine and Neurobehavioral Factors Underlying Mother-Infant Interaction
- ClinicalTrials.gov ID
- NCT01134770
- Acronym / sponsor ID
- PEEPS / 08-1092
- Conditions
- Pregnancy
- Keywords
- Prenatal Substance Use, Cocaine, Cigarette Smoking, Mothers, Pregnant women, Smoking Mothers
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- Jul 2008 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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):
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prenatal Cocaine | – | –Use of cocaine at anytime during pregnancy. Subjects may also have used other drugs in combination with Cocaine |
| 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. |
| Drug-Free Pregnancy | – | –Subjects did not use any of the following drugs during pregnancy: cocaine, nicotine, alcohol, marijuana. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women or mothers with their newborn infants.
Key inclusion criteria (6 listed)
- During pregnancy, mother has used any of the following:
- Mother is pregnant or no more than 4 weeks postpartum
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes
Time frame: 2 to 4 weeks of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Karen Grewen, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the effect of prenatal cocaine exposure on the neonatal brain. ventricular volumes (time frame: 2 to 4 weeks of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.