Placental Passage of Free and Esterified Phytosterols in Humans

Study Overview
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Brief Summary
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Total plasma cholesterol rises by 60 % with progressing pregnancy in humans. Because lipid-lowering drugs are contraindicated during pregnancy, natural compounds, such as phytosterols, may be a safe and effective alternative to prevent undesirable effects. Information on phytosterols in pregnancy is so far very limited. To date, to the best of our knowledge, no studies have characterized the maternal-fetal gradient of free and esterified phytosterols in full-term human pregnancy. For this purpose, maternal and cord blood cholesterol and non-cholesterol sterol (campesterol, stigmasterol, sitosterol) concentrations were measured in term pregnant women at delivery by using gas chromatography-mass spectrometry.

Official Title
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The Maternal-fetal Gradient of Free and Esterified Phytosterols in Term Human Pregnancy at Delivery

Conditions
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Mother Fetus Relations

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A single pregnancy A gestational age determined from known last maternal menstrual period higher than 37 weeks A normal diet without phytosterol supplementation during pregnancy Written informed consent available. Exclusion Criteria: Major congenital anomalies Maternal history of cardiovascular disease Endocrine disorders such as diabetes, hypercholesterolemia, pre-eclampsia, thyroid or adrenal problems Clinical chorioamnionitis

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Free and esterified phytosterol ratio | Plasma free and esterified phytosterol concentrations will be measured in mother-cord blood pairs at delivery. Plasma phytosterol concentrations will be the sum of plasma campesterol, stigmasterol and sitosterol concentrations (mg/L). Gas chromatography-mass spectrometry will be used for measurements. | the day of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total cholesterol concentrations | plasma cholesterol concentrations (mg/L) will be measured to evaluate the cholesterol metabolism in mother-cord blood pairs at delivery. Total cholesterol in pregnant women and cord blood will be calculated from plasma free and esterified cholesterol. Cholesterol concentrations will be measured by using gas chromatography-mass spectrometry. | the day of delivery | 
| total lathosterol concentrations | plasma lathosterol concentrations (mg/L) will be measured to evaluate the cholesterol metabolism in mother-cord blood pairs at delivery. Total lathosterol in pregnant women and cord blood will be calculated from plasma free and esterified lathosterol. Lathosterol concentrations will be measured by using gas chromatography-mass spectrometry. | the day of delivery | 
| total 7-dehydrocholesterol concentrations | plasma 7-dehydrocholesterol concentrations (mg/L) will be measured to evaluate the cholesterol metabolism in mother-cord blood pairs at delivery. Total 7-dehydrocholesterol in pregnant women and cord blood will be calculated from plasma free and esterified 7-dehydrocholesterol. 7-dehydrocholesterol concentrations will be measured by using gas chromatography-mass spectrometry. | the day of delivery | 
| total 7-alpha-hydroxycholesterol concentrations | plasma 7-alpha-hydroxycholesterol concentrations (mg/L) will be measured to evaluate the cholesterol metabolism in mother-cord blood pairs at delivery. Total 7-alpha-hydroxycholesterol in pregnant women and cord blood will be calculated from plasma free and esterified 7-alpha-hydroxycholesterol. 7-alpha-hydroxycholesterol concentrations will be measured by using gas chromatography-mass spectrometry. | the day of delivery | 
| fatty acid concentrations | plasma fatty acid concentrations (mg/dl) will be measured to evaluate the fat metabolism in mother-cord blood pairs at delivery. Total fatty acids will be measured by using gas chromatography with flame ionization detector will be used for the measurement of fatty acids. | the day of delivery |