Smoking Clinical Trial
Official title:
Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels
NCT number | NCT02610751 |
Other study ID # | 15-063 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 2016 |
Est. completion date | August 26, 2019 |
Verified date | August 2019 |
Source | TriHealth Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
- 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.
Status | Completed |
Enrollment | 80 |
Est. completion date | August 26, 2019 |
Est. primary completion date | August 26, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Bethesda North Hospital | Cincinnati | Ohio |
United States | Good Samaritan Hospital | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
TriHealth Inc. |
United States,
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* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Female Fetal Testosterone level | At delivery |
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