SmokingNCT02610751
Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels
An observational study of Smoking, run by TriHealth Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Smoking
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2016to 26 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Good Samaritan Hospital
Cincinnati, Ohio, 45220
Bethesda North Hospital
Cincinnati, Ohio, 45242
About this study
- 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.
Read the 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.
- Conditions
- Smoking
- Keywords
- Maternal Smoking, Female Fetal Testosterone, Anogenital Distance, Maternal Testosterone, Maternal Cotinine
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Smoking | No interventions were applied to this group. Measurements of female fetal testosterone, maternal cotinine and testosterone levels, newborn anogenital distance, second digit to fourth digit (2D:4D) finger length ratio, newborn length and birth weight are collected. | |
| Non-smoking | No interventions were applied to this group. Measurements of female fetal testosterone, maternal cotinine and testosterone levels, newborn anogenital distance, second digit to fourth digit (2D:4D) finger length ratio, newborn length and birth weight are collected. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Fetal Testosterone level
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startJan 2016
- Primary completion26 Aug 2019
- Study completion26 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dave Dhanraj, MD, MBA, Principal investigator, TriHealth Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610751
- Sponsor's protocol ID
- 15-063
- Status last verified
- Aug 2019
- First submitted
- 28 Oct 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Smith LM, Cloak CC, Poland RE, Torday J, Ross MG. Prenatal nicotine increases testosterone levels in the fetus and female offspring. Nicotine Tob Res. 2003 Jun;5(3):369-74. doi: 10.1080/146222031000094196.
PubMed 12791533Centers for Disease Control and Prevention (US); National Center for Chronic Disease Prevention and Health Promotion (US); Office on Smoking and Health (US). How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK53017/
PubMed 21452462Duskova M, Hruskovicova H, Simunkova K, Starka L, Parizek A. The effects of smoking on steroid metabolism and fetal programming. J Steroid Biochem Mol Biol. 2014 Jan;139:138-43. doi: 10.1016/j.jsbmb.2013.05.003. Epub 2013 May 14.
PubMed 23685014Cornelius MD, Day NL. Developmental consequences of prenatal tobacco exposure. Curr Opin Neurol. 2009 Apr;22(2):121-5. doi: 10.1097/WCO.0b013e328326f6dc.
PubMed 19532034Cornelius MD, Leech SL, Goldschmidt L, Day NL. Is prenatal tobacco exposure a risk factor for early adolescent smoking? A follow-up study. Neurotoxicol Teratol. 2005 Jul-Aug;27(4):667-76. doi: 10.1016/j.ntt.2005.05.006.
PubMed 16014324Day NL, Richardson GA, Goldschmidt L, Cornelius MD. Effects of prenatal tobacco exposure on preschoolers' behavior. J Dev Behav Pediatr. 2000 Jun;21(3):180-8.
PubMed 10883878Ernst A, Kristensen SL, Toft G, Thulstrup AM, Hakonsen LB, Olsen SF, Ramlau-Hansen CH. Maternal smoking during pregnancy and reproductive health of daughters: a follow-up study spanning two decades. Hum Reprod. 2012 Dec;27(12):3593-600. doi: 10.1093/humrep/des337. Epub 2012 Oct 2.
PubMed 23034153Barbieri RL, York CM, Cherry ML, Ryan KJ. The effects of nicotine, cotinine and anabasine on rat adrenal 11 beta-hydroxylase and 21-hydroxylase. J Steroid Biochem. 1987 Jul;28(1):25-8. doi: 10.1016/0022-4731(87)90119-1.
PubMed 3497305Matta SG, Valentine JD, Sharp BM. Nicotinic activation of CRH neurons in extrahypothalamic regions of the rat brain. Endocrine. 1997 Oct;7(2):245-53. doi: 10.1007/BF02778147.
PubMed 9549051Stroud LR, Papandonatos GD, Shenassa E, Rodriguez D, Niaura R, LeWinn KZ, Lipsitt LP, Buka SL. Prenatal glucocorticoids and maternal smoking during pregnancy independently program adult nicotine dependence in daughters: a 40-year prospective study. Biol Psychiatry. 2014 Jan 1;75(1):47-55. doi: 10.1016/j.biopsych.2013.07.024. Epub 2013 Sep 10.
PubMed 24034414Benowitz NL. Cotinine as a biomarker of environmental tobacco smoke exposure. Epidemiol Rev. 1996;18(2):188-204. doi: 10.1093/oxfordjournals.epirev.a017925. No abstract available.
PubMed 9021312Benowitz NL, Jacob P 3rd, Fong I, Gupta S. Nicotine metabolic profile in man: comparison of cigarette smoking and transdermal nicotine. J Pharmacol Exp Ther. 1994 Jan;268(1):296-303.
PubMed 8301571James WH. Potential explanation of the reported association between maternal smoking and autism. Environ Health Perspect. 2013 Feb;121(2):a42. doi: 10.1289/ehp.1206268. No abstract available.
PubMed 23380543Fowler PA, Bhattacharya S, Flannigan S, Drake AJ, O'Shaughnessy PJ. Maternal cigarette smoking and effects on androgen action in male offspring: unexpected effects on second-trimester anogenital distance. J Clin Endocrinol Metab. 2011 Sep;96(9):E1502-6. doi: 10.1210/jc.2011-1100. Epub 2011 Jul 13.
PubMed 21752894Thankamony A, Ong KK, Dunger DB, Acerini CL, Hughes IA. Anogenital distance from birth to 2 years: a population study. Environ Health Perspect. 2009 Nov;117(11):1786-90. doi: 10.1289/ehp.0900881. Epub 2009 Jul 13.
PubMed 20049133
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Smoking During Pregnancy and Female Fetal Testosterone Levels
- ClinicalTrials.gov ID
- NCT02610751
- Acronym / sponsor ID
- 15-063
- Conditions
- Smoking
- Keywords
- Maternal Smoking, Female Fetal Testosterone, Anogenital Distance, Maternal Testosterone, Maternal Cotinine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Jan 2016
- Primary completion
- 26 Aug 2019 (actual)
- Study completion
- 26 Aug 2019 (actual)
- First posted
- 20 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking | – | –No interventions were applied to this group. Measurements of female fetal testosterone, maternal cotinine and testosterone levels, newborn anogenital distance, second digit to fourth digit (2D:4D) finger length ratio, newborn length and birth weight are collected. |
| Non-smoking | – | –No interventions were applied to this group. Measurements of female fetal testosterone, maternal cotinine and testosterone levels, newborn anogenital distance, second digit to fourth digit (2D:4D) finger length ratio, newborn length and birth weight are collected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Female Fetal Testosterone level
Time frame: At delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Background: PubMed 12791533Smith LM, Cloak CC, Poland RE, Torday J, Ross MG. Prenatal nicotine increases testosterone levels in the fetus and female offspring. Nicotine Tob Res. 2003 Jun;5(3):369-74. doi: 10.1080/146222031000094196.
- Background: PubMed 21452462Centers for Disease Control and Prevention (US); National Center for Chronic Disease Prevention and Health Promotion (US); Office on Smoking and Health (US). How Tobacco Smoke Causes Disease: The Biology and Behavioral Basis for Smoking-Attributable Disease: A Report of the Surgeon General. Atlanta (GA): Centers for Disease Control and Prevention (US); 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK53017/
- Background: PubMed 23685014Duskova M, Hruskovicova H, Simunkova K, Starka L, Parizek A. The effects of smoking on steroid metabolism and fetal programming. J Steroid Biochem Mol Biol. 2014 Jan;139:138-43. doi: 10.1016/j.jsbmb.2013.05.003. Epub 2013 May 14.
- Background: PubMed 19532034Cornelius MD, Day NL. Developmental consequences of prenatal tobacco exposure. Curr Opin Neurol. 2009 Apr;22(2):121-5. doi: 10.1097/WCO.0b013e328326f6dc.
- Background: PubMed 16014324Cornelius MD, Leech SL, Goldschmidt L, Day NL. Is prenatal tobacco exposure a risk factor for early adolescent smoking? A follow-up study. Neurotoxicol Teratol. 2005 Jul-Aug;27(4):667-76. doi: 10.1016/j.ntt.2005.05.006.
- Background: PubMed 10883878Day NL, Richardson GA, Goldschmidt L, Cornelius MD. Effects of prenatal tobacco exposure on preschoolers' behavior. J Dev Behav Pediatr. 2000 Jun;21(3):180-8.
- Background: PubMed 23034153Ernst A, Kristensen SL, Toft G, Thulstrup AM, Hakonsen LB, Olsen SF, Ramlau-Hansen CH. Maternal smoking during pregnancy and reproductive health of daughters: a follow-up study spanning two decades. Hum Reprod. 2012 Dec;27(12):3593-600. doi: 10.1093/humrep/des337. Epub 2012 Oct 2.
- Background: PubMed 3497305Barbieri RL, York CM, Cherry ML, Ryan KJ. The effects of nicotine, cotinine and anabasine on rat adrenal 11 beta-hydroxylase and 21-hydroxylase. J Steroid Biochem. 1987 Jul;28(1):25-8. doi: 10.1016/0022-4731(87)90119-1.
- Background: PubMed 9549051Matta SG, Valentine JD, Sharp BM. Nicotinic activation of CRH neurons in extrahypothalamic regions of the rat brain. Endocrine. 1997 Oct;7(2):245-53. doi: 10.1007/BF02778147.
- Background: PubMed 24034414Stroud LR, Papandonatos GD, Shenassa E, Rodriguez D, Niaura R, LeWinn KZ, Lipsitt LP, Buka SL. Prenatal glucocorticoids and maternal smoking during pregnancy independently program adult nicotine dependence in daughters: a 40-year prospective study. Biol Psychiatry. 2014 Jan 1;75(1):47-55. doi: 10.1016/j.biopsych.2013.07.024. Epub 2013 Sep 10.
- Background: PubMed 9021312Benowitz NL. Cotinine as a biomarker of environmental tobacco smoke exposure. Epidemiol Rev. 1996;18(2):188-204. doi: 10.1093/oxfordjournals.epirev.a017925. No abstract available.
- Background: PubMed 8301571Benowitz NL, Jacob P 3rd, Fong I, Gupta S. Nicotine metabolic profile in man: comparison of cigarette smoking and transdermal nicotine. J Pharmacol Exp Ther. 1994 Jan;268(1):296-303.
- Individual participant dataSharing planned: No
Related trials for Smoking
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dave Dhanraj, MD, MBA principal investigator
TriHealth Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, run by TriHealth Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Fetal Testosterone level (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02610751, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.