Effects of Maternal Smoking on Fetal Liver Circulation

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ultrasound; Smoking, Cigarette; Liver; Maternal Exposure; Fetal; Circulation
• Intervention / Treatment: Other: smoking

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 Type: Observational
• Enrollment (Anticipated): 160

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Bezmialem Vakıf University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

women who smoke during singleton pregnancy, without fetal anomaly and systemic disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: smoking; to assess the effect of smoking of fetal liver circulation with prenatal Doppler Ultrasonography
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	24-36 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24-36 weeks of pregnancy
Sensitivity and specificity of maternal expiratory CO levels for detecting maternal smoking during pregnancy		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.	24-36 weeks of pregnancy

Collaborators and Investigators

• Sponsor: Bezmialem Vakif University
• Collaborators: Maternal Fetal Medicine and Perinatology Society of Turkey

Publications and helpful links

General 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.
• 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.
• Kiserud T. Fetal venous circulation--an update on hemodynamics. J Perinat Med. 2000;28(2):90-6. doi: 10.1515/JPM.2000.011.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2020
• Primary Completion (Actual): September 10, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 19, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Smoking; Carbon monoxide; Cotinine; Fetal; Liver circulation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome
• Other Study ID Numbers: 06/109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No