Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Female Fetal Testosterone level
研究概览
简要总结
- 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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Female Fetal Testosterone level
时间窗: At delivery
次要结局
未报告次要终点