An observational study in Smoking, sponsored by TriHealth Inc.. Completed at 2 sites in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-28.
Sponsored by TriHealth Inc. · Observational
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.
325 studies on the registry are indexed under Smoking; 141 are open to participants now.
This study's enrollment of 80 is below the median of 114 across 69 observational studies indexed under Smoking.
Browse Smoking studies →TriHealth Inc. is the lead sponsor of 102 studies on the registry; 9 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.
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Smoking and non-smoking women greater than 18 years of age with a current singleton pregnancy with known female fetus confirmed by ultrasound.
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Exclusion Criteria:
No interventions were applied to this group. Measurements of female fetal testosterone, maternal cotinine and testosterone levels, newborn anogenital distance, second digit to fourth digit (2D:4D) finger length ratio, newborn length and birth weight are collected.
No interventions were applied to this group. Measurements of female fetal testosterone, maternal cotinine and testosterone levels, newborn anogenital distance, second digit to fourth digit (2D:4D) finger length ratio, newborn length and birth weight are collected.
Female Fetal Testosterone level
Time frame: At delivery
Plan to share: No
The record gives a start of Jan 2016, a primary completion of Aug 2019 and a completion of Aug 2019. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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