Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels

Completed

Conditions studied: Smoking

In brief

* 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.

Key facts

Study ID: NCT02610751
Run by: TriHealth Inc.
People needed: 80
Starts: 2016-01-01
Expected to finish: 2019-08-26
Last updated by the study team: 2019-08-28

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Good Samaritan Hospital — Cincinnati, Ohio, United States
Bethesda North Hospital — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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