Clinical trial NCT04721782: Effects of Maternal Smoking on Fetal Liver Circulation
Official title: Assessment of Effects of Maternal Smoking on Fetal Liver Circulation With Ultrasonography
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Smoking, Cigarette
Maternal Exposure
Ultrasound
Fetal; Circulation
Liver
Keywords: Cotinine
Carbon monoxide
Smoking
Fetal
Liver circulation
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
Collaborators: name: Maternal Fetal Medicine and Perinatology Society of Turkey
First posted: 2021-01-25
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who smoke during singleton pregnancy, without fetal anomaly and systemic disease

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* smoking more than one cigarette in a day

Exclusion Criteria:

* fetal anomaly
* pregnant women with systemic disease
* younger than 18 years

Primary outcomes:
measure: Comparison of hepatic venous flow between smoking and non- smoking pregnant women
timeFrame: 24-36 weeks of pregnancy
Secondary outcomes:
measure: The effect of maternal smoking on fetal growth
timeFrame: 24-36 weeks of pregnancy
measure: Sensitivity and specificity of maternal expiratory CO levels for detecting maternal smoking during pregnancy
timeFrame: 24-36 weeks of pregnancy
measure: Normal references values of fetal umbilical venous and portal venous flow in Turkish Population
timeFrame: 24-36 weeks of pregnancy
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University
Study officials:
References:
citation: 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.
citation: Kallen 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.
citation: Kiserud T. Fetal venous circulation--an update on hemodynamics. J Perinat Med. 2000;28(2):90-6. doi: 10.1515/JPM.2000.011.