Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels



Status:Recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:12/30/2018
Start Date:January 2016
End Date:May 2019
Contact:Ganga Devaiah, MS
Email:ganga_devaiah@trihealth.com
Phone:513-862-2341

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- 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.

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.

Inclusion Criteria:

- Women, >/= 18 years old

- Current singleton pregnancy

- Recruited prior to 3rd trimester lab visit

- Known female fetus confirmed by Ultrasound, typically performed 18 to 22 weeks, or
later gestational age (GA)

- Self reported smoker (of at least ½ pack per day) or non-smoker documented in
electronic chart.

- Eligibility will not be limited by desired mode of delivery

Exclusion Criteria:

- Patients who successfully quit smoking at <14 weeks gestation and who have not resumed
smoking during the pregnancy will be excluded from the case/control arm of study.

- Patients considered light smokers, who self report smoking less than ½ pack per day.

- Patients with Polycystic Ovarian Syndrome
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Cincinnati, Ohio 45242
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