Tobacco Smoke PollutionNCT07201181
Prenatal Tobacco Exposure and Newborn Outcomes: A Maternal Urinary Cotinine Study
An observational study of Tobacco Smoke Pollution and Maternal Exposure During Pregnancy, run by Haseki Training and Research Hospital.
Trial summary
Prenatal exposure to tobacco smoke, through either active maternal smoking or secondhand exposure, has been associated with impaired fetal oxygenation, metabolic stress, and adverse early neonatal outcomes. Read more about this study
- Who is it for?
- Ages 0 minutes to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoke Pollution, Maternal Exposure During Pregnancy, Infant, Newborn
- What is being tested?
- Maternal Urinary Cotinine Assessment
- Type of treatment
- Injection or infusion
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 0 minutes to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Study population: This is a single-center prospective cohort study conducted at a tertiary hospital. Consecutive eligible mother-newborn dyads are recruited during the delivery hospitalization. Maternal clean-catch urine is collected within 24 hours before delivery for cotinine and creatinine measurement. Dyads are classified as active exposure, passive exposure, or no exposure according to prespecified urinary cotinine-to-creatinine thresholds and maternal exposure history. Outcomes are obtained mainly from routine care and include cord blood lactate, pH, base excess, FCOHb, birthweight, anthropometric measurements, Apgar scores, vital signs, early laboratory results, newborn screening TSH, hearing screening, and follow-up weight loss and bilirubin where available. No experimental intervention or additional neonatal blood sampling is planned.
Who may be able to join
- Pregnant individual expected to deliver a liveborn infant at the study hospital and providing written informed consent before delivery.
- Singleton pregnancy with an anticipated gestational age of ≥35 completed weeks at delivery.
- Maternal clean-catch urine sample obtainable within 24 hours before delivery, preferably at admission and before intravenous fluid administration, for urinary cotinine and creatinine measurement.
- Availability of routine umbilical cord blood gas analysis at birth, including at minimum lactate, pH, and base excess, with fetal carboxyhemoglobin recorded when available.
- Availability of routine neonatal clinical data, including birthweight, anthropometric measurements, Apgar scores, vital signs, and early postnatal assessments according to unit practice.
Who cannot join
- Multiple gestation.
- Major congenital anomaly, known chromosomal or genetic disorder, or major metabolic disease likely to affect neonatal adaptation or the study outcomes.
- Emergency clinical circumstances in which obtaining informed consent or the maternal urine sample could delay or interfere with urgent maternal or neonatal care.
- Inability to obtain an adequate maternal urine sample before delivery for cotinine and creatinine measurement.
- Severe perinatal condition preventing acquisition or reliable interpretation of the primary outcome data, including major birth trauma or prolonged intensive care requirement.
- Missing umbilical cord blood lactate measurement or other critical primary outcome data.
- Previous enrollment of the same mother-newborn dyad.
About this study
Official title: Association of Prenatal Tobacco Exposure Verified by Maternal Urinary Cotinine With Umbilical Cord Blood Lactate, Fetal Carboxyhemoglobin, and Early Neonatal Outcomes: A Prospective Single-Center Observational Study
Prenatal exposure to tobacco smoke, through either active maternal smoking or secondhand exposure, has been associated with impaired fetal oxygenation, metabolic stress, and adverse early neonatal outcomes. This prospective, single-center observational cohort study will objectively assess maternal tobacco exposure using cotinine measured in maternal urine and examine its association with early neonatal biochemical, metabolic, and clinical outcomes.
Consecutive eligible mother-newborn dyads will be recruited at a tertiary academic hospital after written informed consent is obtained. A clean-catch midstream maternal urine sample will be collected within 24 hours before delivery, preferably at admission to the delivery unit and before intravenous fluid administration, for quantitative cotinine and creatinine measurement. Maternal tobacco exposure will be assessed using the urinary cotinine concentration, the cotinine-to-creatinine ratio, and maternal self-reported smoking and secondhand smoke exposure. Based on prespecified biomarker thresholds and exposure history, participants will be classified as having active exposure, passive exposure, or no exposure. No experimental intervention will be administered.
Read more
Neonatal data will include umbilical cord blood gas parameters, including pH, pCO2, pO2, base excess, bicarbonate, lactate, and fetal carboxyhemoglobin (FCOHb). Birthweight, length, head circumference, Apgar scores, oxygen saturation, heart rate, and blood pressure will also be recorded. Routine laboratory measurements obtained during the early postnatal period will include complete blood count parameters, hematologic and inflammatory indices such as NLR and PLR, albumin, the albumin-to-lactate ratio, HDL, LDL, and other routinely available biochemical markers. Thyroid-stimulating hormone results from the national newborn screening program and newborn hearing screening results will be recorded. Postnatal weight loss and bilirubin measurements from routine follow-up visits will also be collected when available.
The primary objective is to determine whether increasing maternal urinary cotinine exposure is associated with higher umbilical cord blood lactate and FCOHb levels, indicating greater metabolic stress and impaired fetal oxygenation. Secondary objectives include evaluating associations with cord blood gas parameters, birthweight, early hematologic and biochemical indices, albumin and the albumin-to-lactate ratio, blood pressure, bilirubin levels, thyroid screening results, and hearing screening outcomes.
Maternal, obstetric, and perinatal variables, including maternal age, parity, gestational age, mode of delivery, smoking history, intrapartum factors, and relevant maternal comorbidities, will be recorded for adjusted analyses. Statistical analyses will include comparisons among the three exposure groups and multivariable regression models evaluating urinary cotinine both as a continuous measure and as a categorical exposure variable.
This study is designed to provide prospectively collected, biomarker-verified evidence regarding the relationship between maternal tobacco exposure and immediate neonatal metabolic, hematologic, and physiologic outcomes using measurements that are feasible within routine clinical care.
- Conditions
- Tobacco Smoke Pollution, Maternal Exposure During Pregnancy, Infant, Newborn, Carbon Monoxide Poisoning
- Being tested
- Maternal Urinary Cotinine Assessment
- Keywords
- Prenatal Tobacco Exposure, Maternal Smoking
- Medical subject headings
- Carbon Monoxide Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Urinary Cotinine AssessmentOther
A clean-catch midstream maternal urine sample will be collected within 24 hours before delivery, preferably at admission to the delivery unit and before intravenous fluid administration. Urinary cotinine and creatinine concentrations will be measured, and the cotinine-to-creatinine ratio will be used to objectively classify prenatal tobacco exposure. No treatment or behavioral intervention will be assigned.
| Study group | Role | What they receive |
|---|---|---|
| Active Prenatal Tobacco Exposure (Maternal Urinary Cotinine-Defined) | Mother-newborn dyads in whom the maternal urinary cotinine-to-creatinine ratio is consistent with active tobacco exposure according to the prespecified study threshold. Maternal self-reported smoking and secondhand smoke exposure will also be recorded as supportive exposure information.
Neonatal outcomes will include umbilical cord blood gas parameters, including pH, pCO2, pO2, base excess, bicarbonate, lactate, and fetal carboxyhemoglobin (FCOHb); birthweight and other anthropometric measurements; Apgar scores; oxygen saturation; heart rate; blood pressure; and routine laboratory measurements obtained during the early postnatal period. Laboratory variables will include complete blood count parameters, NLR, PLR, albumin, the albumin-to-lactate ratio, HDL, LDL, and other routinely available biochemical markers. Newborn screening TSH, hearing screening results, postnatal weight loss, and bilirubin measurements will also be recorded where available. Receives: Other: Maternal Urinary Cotinine Assessment | |
| Passive Prenatal Tobacco Exposure (Maternal Urinary Cotinine-Defined) | Mother-newborn dyads in whom the maternal urinary cotinine-to-creatinine ratio is detectable but below the active-exposure threshold and is consistent with passive prenatal tobacco exposure according to the prespecified study thresholds. Maternal self-reported smoking and secondhand smoke exposure will also be recorded as supportive exposure information.
The same neonatal biochemical, metabolic, physiologic, and clinical measurements will be collected as in the active-exposure and reference cohorts. No experimental intervention will be administered. Receives: Other: Maternal Urinary Cotinine Assessment | |
| No Prenatal Tobacco Exposure (Maternal Urinary Cotinine-Defined Reference Cohort) | Mother-newborn dyads in whom the maternal urinary cotinine-to-creatinine ratio is below the prespecified no-exposure threshold or below the analytical detection limit. Maternal smoking and secondhand smoke exposure history will also be recorded to assess agreement between biomarker-based and self-reported exposure classifications.
The same neonatal biochemical, metabolic, physiologic, and clinical measurements will be collected as in the exposed cohorts. No experimental intervention will be administered. Receives: Other: Maternal Urinary Cotinine Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Umbilical Cord Blood Lactate
Umbilical cord blood lactate concentration measured using routine blood gas analysis. Lactate levels will be compared across maternal urinary cotinine-defined exposure groups (active, passive, and no exposure) and evaluated in multivariable regression models with adjustment for relevant maternal and perinatal factors. Unit of Measure: mmol/L.
Measured: At birth (sample obtained within 10 minutes of delivery; analyzed within routine lab turnaround)
Secondary outcomes (3)
Umbilical Cord Blood pH
Arterial/venous cord blood pH per routine gas analysis; association with maternal cotinine exposure categories.
Unit of Measure: pH units
Measured: At birth (within 10 minutes)
Umbilical Cord Blood Base Excess (BE)
Base excess from routine cord gas; group comparisons and adjusted models parallel to primary analysis.
Unit of Measure: mEq/L
Measured: At birth (within 10 minutes)
Fetal Carboxyhemoglobin (FCOHb)
Percent carboxyhemoglobin from cord blood CO-oximetry; tested for dose-response with maternal urinary cotinine.
Unit of Measure: percent
Measured: At birth (same cord sample, routine CO-oximetry if available)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start1 Aug 2026 (estimated)
- Primary completion8 Nov 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tobacco Smoke PollutionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haseki Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berker Okay, Haseki Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201181
- Sponsor's protocol ID
- 141-2025
- Status last verified
- Jul 2026
- First submitted
- 23 Sep 2025
- Last updated
- 21 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abraham M, Alramadhan S, Iniguez C, Duijts L, Jaddoe VW, Den Dekker HT, Crozier S, Godfrey KM, Hindmarsh P, Vik T, Jacobsen GW, Hanke W, Sobala W, Devereux G, Turner S. A systematic review of maternal smoking during pregnancy and fetal measurements with meta-analysis. PLoS One. 2017 Feb 23;12(2):e0170946. doi: 10.1371/journal.pone.0170946. eCollection 2017.
PubMed 28231292Filis P, Hombach-Klonisch S, Ayotte P, Nagrath N, Soffientini U, Klonisch T, O'Shaughnessy P, Fowler PA. Maternal smoking and high BMI disrupt thyroid gland development. BMC Med. 2018 Oct 23;16(1):194. doi: 10.1186/s12916-018-1183-7.
PubMed 30348172Di HK, Gan Y, Lu K, Wang C, Zhu Y, Meng X, Xia WQ, Xu MZ, Feng J, Tian QF, He Y, Nie ZQ, Liu JA, Song FJ, Lu ZX. Maternal smoking status during pregnancy and low birth weight in offspring: systematic review and meta-analysis of 55 cohort studies published from 1986 to 2020. World J Pediatr. 2022 Mar;18(3):176-185. doi: 10.1007/s12519-021-00501-5. Epub 2022 Jan 28.
PubMed 35089538Berlin I, Heilbronner C, Georgieu S, Meier C, Spreux-Varoquaux O. Newborns' cord blood plasma cotinine concentrations are similar to that of their delivering smoking mothers. Drug Alcohol Depend. 2010 Mar 1;107(2-3):250-2. doi: 10.1016/j.drugalcdep.2009.10.008. Epub 2009 Nov 24.
PubMed 19939584Hayde M, Bernaschek G, Stevenson DK, Knight GJ, Haddow JE, Widness JA. Antepartum fetal and maternal carboxyhemoglobin and cotinine levels among cigarette smokers. Acta Paediatr. 1999 Mar;88(3):327-31. doi: 10.1080/08035259950170123.
PubMed 10229047Wang X, Tager IB, Van Vunakis H, Speizer FE, Hanrahan JP. Maternal smoking during pregnancy, urine cotinine concentrations, and birth outcomes. A prospective cohort study. Int J Epidemiol. 1997 Oct;26(5):978-88. doi: 10.1093/ije/26.5.978.
PubMed 9363518
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Prenatal Tobacco Exposure Verified by Maternal Urinary Cotinine With Umbilical Cord Blood Lactate, Fetal Carboxyhemoglobin, and Early Neonatal Outcomes: A Prospective Single-Center Observational Study
- ClinicalTrials.gov ID
- NCT07201181
- Acronym / sponsor ID
- 141-2025
- Conditions
- Tobacco Smoke Pollution, Maternal Exposure During Pregnancy, Infant, Newborn, Carbon Monoxide Poisoning
- Keywords
- Prenatal Tobacco Exposure, Maternal Smoking
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Haseki Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 8 Nov 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Oct 2025 (actual)
- 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.
Prenatal exposure to tobacco smoke, through either active maternal smoking or secondhand exposure, has been associated with impaired fetal oxygenation, metabolic stress, and adverse early neonatal outcomes. This prospective, single-center observational cohort study will objectively assess maternal tobacco exposure using cotinine measured in maternal urine and examine its association with early neonatal biochemical, metabolic, and clinical outcomes.
Consecutive eligible mother-newborn dyads will be recruited at a tertiary academic hospital after written informed consent is obtained. A clean-catch midstream maternal urine sample will be collected within 24 hours before delivery, preferably at admission to the delivery unit and before intravenous fluid administration, for quantitative cotinine and creatinine measurement. Maternal tobacco exposure will be assessed using the urinary cotinine concentration, the cotinine-to-creatinine ratio, and maternal self-reported smoking and secondhand smoke exposure. Based on prespecified biomarker thresholds and exposure history, participants will be classified as having active exposure, passive exposure, or no exposure. No experimental intervention will be administered.
Neonatal data will include umbilical cord blood gas parameters, including pH, pCO2, pO2, base excess, bicarbonate, lactate, and fetal carboxyhemoglobin (FCOHb). Birthweight, length, head circumference, Apgar scores, oxygen saturation, heart rate, and blood pressure will also be recorded. Routine laboratory measurements obtained during the early postnatal period will include complete blood count parameters, hematologic and inflammatory indices such as NLR and PLR, albumin, the albumin-to-lactate ratio, HDL, LDL, and other routinely available biochemical markers. Thyroid-stimulating hormone results from the national newborn screening program and newborn hearing screening results will be recorded. Postnatal weight loss and bilirubin measurements from routine follow-up visits will also be collected when available.
The primary objective is to determine whether increasing maternal urinary cotinine exposure is associated with higher umbilical cord blood lactate and FCOHb levels, indicating greater metabolic stress and impaired fetal oxygenation. Secondary objectives include evaluating associations with cord blood gas parameters, birthweight, early hematologic and biochemical indices, albumin and the albumin-to-lactate ratio, blood pressure, bilirubin levels, thyroid screening results, and hearing screening outcomes.
Maternal, obstetric, and perinatal variables, including maternal age, parity, gestational age, mode of delivery, smoking history, intrapartum factors, and relevant maternal comorbidities, will be recorded for adjusted analyses. Statistical analyses will include comparisons among the three exposure groups and multivariable regression models evaluating urinary cotinine both as a continuous measure and as a categorical exposure variable.
This study is designed to provide prospectively collected, biomarker-verified evidence regarding the relationship between maternal tobacco exposure and immediate neonatal metabolic, hematologic, and physiologic outcomes using measurements that are feasible within routine clinical care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Prenatal Tobacco Exposure (Maternal Urinary Cotinine-Defined) | – | Other: Maternal Urinary Cotinine AssessmentMother-newborn dyads in whom the maternal urinary cotinine-to-creatinine ratio is consistent with active tobacco exposure according to the prespecified study threshold. Maternal self-reported smoking and secondhand smoke exposure will also be recorded as supportive exposure information. Neonatal outcomes will include umbilical cord blood gas parameters, including pH, pCO2, pO2, base excess, bicarbonate, lactate, and fetal carboxyhemoglobin (FCOHb); birthweight and other anthropometric measurements; Apgar scores; oxygen saturation; heart rate; blood pressure; and routine laboratory measurements obtained during the early postnatal period. Laboratory variables will include complete blood count parameters, NLR, PLR, albumin, the albumin-to-lactate ratio, HDL, LDL, and other routinely available biochemical markers. Newborn screening TSH, hearing screening results, postnatal weight loss, and bilirubin measurements will also be recorded where available. |
| Passive Prenatal Tobacco Exposure (Maternal Urinary Cotinine-Defined) | – | Other: Maternal Urinary Cotinine AssessmentMother-newborn dyads in whom the maternal urinary cotinine-to-creatinine ratio is detectable but below the active-exposure threshold and is consistent with passive prenatal tobacco exposure according to the prespecified study thresholds. Maternal self-reported smoking and secondhand smoke exposure will also be recorded as supportive exposure information. The same neonatal biochemical, metabolic, physiologic, and clinical measurements will be collected as in the active-exposure and reference cohorts. No experimental intervention will be administered. |
| No Prenatal Tobacco Exposure (Maternal Urinary Cotinine-Defined Reference Cohort) | – | Other: Maternal Urinary Cotinine AssessmentMother-newborn dyads in whom the maternal urinary cotinine-to-creatinine ratio is below the prespecified no-exposure threshold or below the analytical detection limit. Maternal smoking and secondhand smoke exposure history will also be recorded to assess agreement between biomarker-based and self-reported exposure classifications. The same neonatal biochemical, metabolic, physiologic, and clinical measurements will be collected as in the exposed cohorts. No experimental intervention will be administered. |
Who may qualify
- Ages
- 0 minutes to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This is a single-center prospective cohort study conducted at a tertiary hospital. Consecutive eligible mother-newborn dyads are recruited during the delivery hospitalization. Maternal clean-catch urine is collected within 24 hours before delivery for cotinine and creatinine measurement. Dyads are classified as active exposure, passive exposure, or no exposure according to prespecified urinary cotinine-to-creatinine thresholds and maternal exposure history. Outcomes are obtained mainly from routine care and include cord blood lactate, pH, base excess, FCOHb, birthweight, anthropometric measurements, Apgar scores, vital signs, early laboratory results, newborn screening TSH, hearing screening, and follow-up weight loss and bilirubin where available. No experimental intervention or additional neonatal blood sampling is planned.
Key inclusion criteria (5 listed)
- Pregnant individual expected to deliver a liveborn infant at the study hospital and providing written informed consent before delivery.
- Singleton pregnancy with an anticipated gestational age of ≥35 completed weeks at delivery.
- Maternal clean-catch urine sample obtainable within 24 hours before delivery, preferably at admission and before intravenous fluid administration, for urinary cotinine and creatinine measurement.
- Availability of routine umbilical cord blood gas analysis at birth, including at minimum lactate, pH, and base excess, with fetal carboxyhemoglobin recorded when available.
- Availability of routine neonatal clinical data, including birthweight, anthropometric measurements, Apgar scores, vital signs, and early postnatal assessments according to unit practice.
Key exclusion criteria (7 listed)
- Multiple gestation.
- Major congenital anomaly, known chromosomal or genetic disorder, or major metabolic disease likely to affect neonatal adaptation or the study outcomes.
- Emergency clinical circumstances in which obtaining informed consent or the maternal urine sample could delay or interfere with urgent maternal or neonatal care.
- Inability to obtain an adequate maternal urine sample before delivery for cotinine and creatinine measurement.
- Severe perinatal condition preventing acquisition or reliable interpretation of the primary outcome data, including major birth trauma or prolonged intensive care requirement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal Urinary Cotinine AssessmentA clean-catch midstream maternal urine sample will be collected within 24 hours before delivery, preferably at admission to the delivery unit and before intravenous fluid administration. Urinary cotinine and creatinine concentrations will be measured, and the cotinine-to-creatinine ratio will be used to objectively classify prenatal tobacco exposure. No treatment or behavioral intervention will be assigned. | Other | Active Prenatal Tobacco Exposure (Maternal Urinary Cotinine-Defined), No Prenatal Tobacco Exposure (Maternal Urinary Cotinine-Defined Reference Cohort), Passive Prenatal Tobacco Exposure (Maternal Urinary Cotinine-Defined) |
Primary outcome
Umbilical Cord Blood Lactate
Time frame: At birth (sample obtained within 10 minutes of delivery; analyzed within routine lab turnaround)
Umbilical cord blood lactate concentration measured using routine blood gas analysis. Lactate levels will be compared across maternal urinary cotinine-defined exposure groups (active, passive, and no exposure) and evaluated in multivariable regression models with adjustment for relevant maternal and perinatal factors. Unit of Measure: mmol/L.
3 secondary outcomes
Umbilical Cord Blood pH
Time frame: At birth (within 10 minutes)
Umbilical Cord Blood Base Excess (BE)
Time frame: At birth (within 10 minutes)
Fetal Carboxyhemoglobin (FCOHb)
Time frame: At birth (same cord sample, routine CO-oximetry if available)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Background: PubMed 28231292Abraham M, Alramadhan S, Iniguez C, Duijts L, Jaddoe VW, Den Dekker HT, Crozier S, Godfrey KM, Hindmarsh P, Vik T, Jacobsen GW, Hanke W, Sobala W, Devereux G, Turner S. A systematic review of maternal smoking during pregnancy and fetal measurements with meta-analysis. PLoS One. 2017 Feb 23;12(2):e0170946. doi: 10.1371/journal.pone.0170946. eCollection 2017.
- Background: PubMed 30348172Filis P, Hombach-Klonisch S, Ayotte P, Nagrath N, Soffientini U, Klonisch T, O'Shaughnessy P, Fowler PA. Maternal smoking and high BMI disrupt thyroid gland development. BMC Med. 2018 Oct 23;16(1):194. doi: 10.1186/s12916-018-1183-7.
- Background: PubMed 35089538Di HK, Gan Y, Lu K, Wang C, Zhu Y, Meng X, Xia WQ, Xu MZ, Feng J, Tian QF, He Y, Nie ZQ, Liu JA, Song FJ, Lu ZX. Maternal smoking status during pregnancy and low birth weight in offspring: systematic review and meta-analysis of 55 cohort studies published from 1986 to 2020. World J Pediatr. 2022 Mar;18(3):176-185. doi: 10.1007/s12519-021-00501-5. Epub 2022 Jan 28.
- Background: PubMed 19939584Berlin I, Heilbronner C, Georgieu S, Meier C, Spreux-Varoquaux O. Newborns' cord blood plasma cotinine concentrations are similar to that of their delivering smoking mothers. Drug Alcohol Depend. 2010 Mar 1;107(2-3):250-2. doi: 10.1016/j.drugalcdep.2009.10.008. Epub 2009 Nov 24.
- Background: PubMed 10229047Hayde M, Bernaschek G, Stevenson DK, Knight GJ, Haddow JE, Widness JA. Antepartum fetal and maternal carboxyhemoglobin and cotinine levels among cigarette smokers. Acta Paediatr. 1999 Mar;88(3):327-31. doi: 10.1080/08035259950170123.
- Background: PubMed 9363518Wang X, Tager IB, Van Vunakis H, Speizer FE, Hanrahan JP. Maternal smoking during pregnancy, urine cotinine concentrations, and birth outcomes. A prospective cohort study. Int J Epidemiol. 1997 Oct;26(5):978-88. doi: 10.1093/ije/26.5.978.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Tobacco Smoke Pollution and Maternal Exposure During Pregnancy, run by Haseki Training and Research Hospital.
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 5 inclusion and 7 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: opening soon, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Umbilical Cord Blood Lactate (time frame: At birth (sample obtained within 10 minutes of delivery; analyzed within routine lab turnaround)). 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 NCT07201181, which also lists 6 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 21 Jul 2026.