Clinical Trials Directory

Trials / Completed

CompletedNCT02610751

Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels

Status
Completed
Phase
Study type
Observational
Enrollment
80 (actual)
Sponsor
TriHealth Inc. · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Accepted

Summary

* The investigators hope their study will answer the question of whether or not fetal testosterone levels are increased in female newborns exposed to nicotine as a result of maternal smoking during pregnancy. Secondarily they plan to also evaluate maternal cotinine and testosterone levels and newborn anogenital distance, second digit to fourth digit (2D:4D) finger length ratio, newborn length and birth weight. * The investigators hope by performing this study, they will help to uncover the effect of tobacco exposure in utero on human female fetal testosterone levels, thus improving the counseling for tobacco use in pregnancy.

Detailed description

Epidemiological studies and laboratory research performed on animal models have revealed that the effects of maternal smoking during pregnancy go beyond the perinatal period due to the effect of nicotine on increasing fetal testosterone levels. This is of great concern as an increase fetal testosterone has been linked to impaired reproductive development and infertility in both male and female offspring, early onset of menarche in females, shorter body height, increased BMI, shortened anogenital distance and low second digit to fourth digit finger length ratio. Additionally elevated fetal testosterone levels have been associated with development of psychosocial disorders such as Autism, ADHD, antisocial behavior, conduct disorder, adult criminal behavior, and sensation seeking behavior. Although there have been a few animal studies that have investigated the effects of maternal nicotine exposure on fetal testosterone levels with review of the epidemiologic literature on subsequent adverse implications, no known human studies have been performed to further investigate the relationship between maternal smoking during pregnancy and female fetal testosterone levels.

Conditions

Timeline

Start date
2016-01-01
Primary completion
2019-08-26
Completion
2019-08-26
First posted
2015-11-20
Last updated
2019-08-28

Locations

2 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT02610751. Inclusion in this directory is not an endorsement.