Smoking, CigaretteNCT04721782
Effects of Maternal Smoking on Fetal Liver Circulation
An observational study of Smoking, Cigarette and Maternal Exposure, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
According to the hypothesis of this study presented, the effects of smoking on the fetus can be determined by the liver circulation and hepatic metabolism. The basic assumption of this project is; Compensatory and pathological findings can be seen in the fetal liver circulation in babies of mothers who smoke and the… 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, Cigarette, Maternal Exposure, Ultrasound
- What is being tested?
- smoking
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Jul 2020to Jul 2021
- How long will I take part?
- 20 Weeks
- 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: women who smoke during singleton pregnancy, without fetal anomaly and systemic disease
Who may be able to join
- singleton pregnancy
- smoking more than one cigarette in a day
Who cannot join
- fetal anomaly
- pregnant women with systemic disease
- younger than 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Effects of Maternal Smoking on Fetal Liver Circulation With Ultrasonography
According to the hypothesis of this study presented, the effects of smoking on the fetus can be determined by the liver circulation and hepatic metabolism. The basic assumption of this project is; Compensatory and pathological findings can be seen in the fetal liver circulation in babies of mothers who smoke and the findings can be valuable in predicting the direction of fetal development (growth retardation or normal development). In this study, the flow and shunt amounts in the fetal hepatic vessels in normal and smoking pregnant women will be calculated with the help of Doppler US.
Read the detailed description
Smoking is an agent that negatively affects of uteroplacental circulation and fetal development due to the chemical substances it contains, especially carbon monoxide and nicotine. According to the hypothesis of this study presented, the effects of smoking on the fetus can be determined by the liver circulation and hepatic metabolism. The basic assumption of this project is; Compensatory and pathological findings can be seen in the fetal liver circulation in babies of mothers who smoke and the findings can be valuable in predicting the direction of fetal development (growth retardation or normal development). In this study, the flow and shunt amounts in the fetal hepatic vessels in normal and smoking pregnant women will be calculated with the help of Doppler US.Therefore, we try to delineate pathological circulatory pattern in these fetuses and shed light to the mechanism of smoking-induced abnormal fetal development. In addition, the effects of other maternal demographic factors, cigarette amount, cotinine and expiratory carbon monoxide levels (or any correlation between them) on hepatic circulation and fetal development will be examined.
- Conditions
- Smoking, Cigarette, Maternal Exposure, Ultrasound, Fetal; Circulation, Liver
- Being tested
- smoking
- Keywords
- Cotinine, Carbon monoxide, Smoking, Fetal, Liver circulation
- Medical subject headings
- Cigarette Smoking, Persistent Fetal Circulation Syndrome, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smokingOther
to assess the effect of smoking of fetal liver circulation with prenatal Doppler Ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| otherwise healthy, smoking, singleton pregnant women between 24- 36 weeks | Fetal liver circulation will be evaluated with doppler ultrasound, The degree of maternal smoking will be assessed by measuring urine cotinine and exhaled carbon monokside levels Receives: Other: smoking | |
| otherwise healthy, non-smoking, singleton pregnant women between 24- 36 weeks | Fetal liver circulation will be evaluated with doppler ultrasound, The degree of maternal smoking will be assessed by measuring urine cotinine and exhaled carbon monokside levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of hepatic venous flow between smoking and non- smoking pregnant women
The evaluation of fetal flow parameters will be done with Voluson E6 and Philips EPIQ Elite ultrasound devices.
In evaluations, diameters and the time avaraged flow velocities in intraabdominal umbilical vein, left portal vein, main portal vein and ductus venosus (DV) will be measured. The flow volumes will be calculated according to the specified formula and the venous flow of the right and left lobes of the liver and total venous flow of the liver will be determined, adjusted for estimated fetal weight and compared between groups.
Flow Formulas; (QUV, QDV, QLPV, QPV):
Total venous Hepatic Flow (Qhep)= (QUV-QDV) + QPV Flow to the left liver lobe(QLL)= QUV - (QDV + QleftPV) Flow to the right hepatic lobe (QrightLobe) = QPV + QleftPV
Measured: 24-36 weeks of pregnancy
Secondary outcomes (3)
The effect of maternal smoking on fetal growth
In the evaluation of fetal growth, fetal biometry (bipariatal diameter, head circumference, abdominal circumference, femur length) will be measured with ultrasound and estimated weight will be calculated with the headlock formula. The calculated weight will be compared with the appropriate (reference) normograms. Cases with estimated fetal weight (EFW) below 10 percentile will be considered as intrauterine growth retardation (IUGR).
In both groups (smoking and non-smoking pregnant women) fetal biometry parameters will be measured and estimated fetal weight will be calculated.To be determined if maternal smoking has an effect on fetal growth retardation.
Measured: 24-36 weeks of pregnancy
Sensitivity and specificity of maternal expiratory CO levels for detecting maternal smoking during pregnancy
Measured: 24-36 weeks of pregnancy
Normal references values of fetal umbilical venous and portal venous flow in Turkish Population
Doppler examination of the umbilical vein and portal vein in non-smokig pregnant women will determine the flow rate, flow volume and flow indexes in these vessels. In this way, it is planned to create a reference scale specific to the week of gestation for these parameters in healthy pregnant women in the Turkish population.
Measured: 24-36 weeks of pregnancy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start7 Jul 2020
- Primary completion10 Sep 2020
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Smoking, CigaretteStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- 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
- 160 participants (estimated)
- Target duration
- 20 Weeks
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Maternal Fetal Medicine and Perinatology Society of Turkey
- Responsible party
- Principal investigator, Mehmet Serdar Kutuk, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721782
- Sponsor's protocol ID
- 06/109
- Status last verified
- Jan 2021
- First submitted
- 3 Dec 2020
- Last updated
- 25 Jan 2021
- Results posted
- No
- Individual data sharing
- No
Publications
Cnattingius S. The epidemiology of smoking during pregnancy: smoking prevalence, maternal characteristics, and pregnancy outcomes. Nicotine Tob Res. 2004 Apr;6 Suppl 2:S125-40. doi: 10.1080/14622200410001669187.
PubMed 15203816Kallen K. Maternal smoking during pregnancy and infant head circumference at birth. Early Hum Dev. 2000 Jun;58(3):197-204. doi: 10.1016/s0378-3782(00)00077-3.
PubMed 10936439Kiserud T. Fetal venous circulation--an update on hemodynamics. J Perinat Med. 2000;28(2):90-6. doi: 10.1515/JPM.2000.011.
PubMed 10875092
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Effects of Maternal Smoking on Fetal Liver Circulation With Ultrasonography
- ClinicalTrials.gov ID
- NCT04721782
- Acronym / sponsor ID
- 06/109
- Conditions
- Smoking, Cigarette, Maternal Exposure, Ultrasound, Fetal; Circulation, Liver
- Keywords
- Cotinine, Carbon monoxide, Smoking, Fetal, Liver circulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Maternal Fetal Medicine and Perinatology Society of Turkey
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 10 Sep 2020 (actual)
- Study completion
- Jul 2021 (estimated)
- First posted
- 25 Jan 2021 (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.
According to the hypothesis of this study presented, the effects of smoking on the fetus can be determined by the liver circulation and hepatic metabolism. The basic assumption of this project is; Compensatory and pathological findings can be seen in the fetal liver circulation in babies of mothers who smoke and the findings can be valuable in predicting the direction of fetal development (growth retardation or normal development). In this study, the flow and shunt amounts in the fetal hepatic vessels in normal and smoking pregnant women will be calculated with the help of Doppler US.
Detailed description
Smoking is an agent that negatively affects of uteroplacental circulation and fetal development due to the chemical substances it contains, especially carbon monoxide and nicotine. According to the hypothesis of this study presented, the effects of smoking on the fetus can be determined by the liver circulation and hepatic metabolism. The basic assumption of this project is; Compensatory and pathological findings can be seen in the fetal liver circulation in babies of mothers who smoke and the findings can be valuable in predicting the direction of fetal development (growth retardation or normal development). In this study, the flow and shunt amounts in the fetal hepatic vessels in normal and smoking pregnant women will be calculated with the help of Doppler US.Therefore, we try to delineate pathological circulatory pattern in these fetuses and shed light to the mechanism of smoking-induced abnormal fetal development. In addition, the effects of other maternal demographic factors, cigarette amount, cotinine and expiratory carbon monoxide levels (or any correlation between them) on hepatic circulation and fetal development will be examined.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 20 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| otherwise healthy, smoking, singleton pregnant women between 24- 36 weeks | – | Other: smokingFetal liver circulation will be evaluated with doppler ultrasound, The degree of maternal smoking will be assessed by measuring urine cotinine and exhaled carbon monokside levels |
| otherwise healthy, non-smoking, singleton pregnant women between 24- 36 weeks | – | –Fetal liver circulation will be evaluated with doppler ultrasound, The degree of maternal smoking will be assessed by measuring urine cotinine and exhaled carbon monokside levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- women who smoke during singleton pregnancy, without fetal anomaly and systemic disease
Key inclusion criteria (2 listed)
- singleton pregnancy
- smoking more than one cigarette in a day
Key exclusion criteria (3 listed)
- fetal anomaly
- pregnant women with systemic disease
- younger than 18 years
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 |
|---|---|---|
| smokingto assess the effect of smoking of fetal liver circulation with prenatal Doppler Ultrasonography | Other | otherwise healthy, smoking, singleton pregnant women between 24- 36 weeks |
Primary outcome
Comparison of hepatic venous flow between smoking and non- smoking pregnant women
Time frame: 24-36 weeks of pregnancy
The evaluation of fetal flow parameters will be done with Voluson E6 and Philips EPIQ Elite ultrasound devices. In evaluations, diameters and the time avaraged flow velocities in intraabdominal umbilical vein, left portal vein, main portal vein and ductus venosus (DV) will be measured. The flow volumes will be calculated according to the specified formula and the venous flow of the right and left lobes of the liver and total venous flow of the liver will be determined, adjusted for estimated fetal weight and compared between groups. Flow Formulas; (QUV, QDV, QLPV, QPV): Total venous Hepatic Flow (Qhep)= (QUV-QDV) + QPV Flow to the left liver lobe(QLL)= QUV - (QDV + QleftPV) Flow to the right hepatic lobe (QrightLobe) = QPV + QleftPV
3 secondary outcomes
The effect of maternal smoking on fetal growth
Time frame: 24-36 weeks of pregnancy
Sensitivity and specificity of maternal expiratory CO levels for detecting maternal smoking during pregnancy
Time frame: 24-36 weeks of pregnancy
Normal references values of fetal umbilical venous and portal venous flow in Turkish Population
Time frame: 24-36 weeks of pregnancy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Background: PubMed 15203816Cnattingius S. The epidemiology of smoking during pregnancy: smoking prevalence, maternal characteristics, and pregnancy outcomes. Nicotine Tob Res. 2004 Apr;6 Suppl 2:S125-40. doi: 10.1080/14622200410001669187.
- Background: PubMed 10936439Kallen K. Maternal smoking during pregnancy and infant head circumference at birth. Early Hum Dev. 2000 Jun;58(3):197-204. doi: 10.1016/s0378-3782(00)00077-3.
- Background: PubMed 10875092Kiserud T. Fetal venous circulation--an update on hemodynamics. J Perinat Med. 2000;28(2):90-6. doi: 10.1515/JPM.2000.011.
- Individual participant dataSharing planned: No
Related trials for Smoking, Cigarette
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 recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Active, not recruiting
Assessment of HPHC Exposure in Smokers Switching to THS/TP18 With Different Device Variants
Smoking
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking, Cigarette and Maternal Exposure, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 2 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: status not confirmed, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Results are not available in the source record.
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?
Comparison of hepatic venous flow between smoking and non- smoking pregnant women (time frame: 24-36 weeks of pregnancy). 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 NCT04721782, which also lists 3 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 25 Jan 2021.