Clinical trial NCT02610751: Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels
Official title: Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Keywords: Maternal Smoking
Female Fetal Testosterone
Anogenital Distance
Maternal Testosterone
Maternal Cotinine
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Smoking and non-smoking women greater than 18 years of age with a current singleton pregnancy with known female fetus confirmed by ultrasound.

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Female Fetal Testosterone level
timeFrame: At delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Good Samaritan Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital
state: Ohio
Study officials:
affiliation: TriHealth Inc.
name: Dave Dhanraj, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
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