Effects of Maternal Smoking on Fetal Liver Circulation

NCT04721782 | Unknown

• 1 other identifier: 06/109
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking, Cigarette; Maternal Exposure; Ultrasound; Fetal; Circulation; Liver

Keywords

Cotinine; Carbon monoxide; Smoking; Fetal; Liver circulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• The effect of maternal smoking on fetal growth

  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

  24-36 weeks of pregnancy

Study Arms (2)

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

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

Interventions

smoking OTHER

to assess the effect of smoking of fetal liver circulation with prenatal Doppler Ultrasonography

otherwise healthy, smoking, singleton pregnant women between 24- 36 weeks

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Bezmialem Vakif University: lead
• Maternal Fetal Medicine and Perinatology Society of Turkey: collaborator

Study Sites (1)

Bezmialem Vakıf University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 15203816 BACKGROUND

• 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.

  PMID: 10936439 BACKGROUND

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

  PMID: 10875092 BACKGROUND

MeSH Terms

Conditions

Cigarette Smoking; Persistent Fetal Circulation Syndrome; Smoking

Interventions

Smoking Devices

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use; Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: January 25, 2021
• Study Start: July 7, 2020
• Primary Completion: September 10, 2020
• Study Completion: July 1, 2021
• Last Updated: January 25, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)