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Placental Passage of Free and Esterified Phytosterols in Humans

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03705767
Acronym
PTS
Enrollment
68
Registered
2018-10-15
Start date
2016-10-26
Completion date
2017-10-15
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mother Fetus Relations

Brief summary

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.

Interventions

None listed

Sponsors

Università Politecnica delle Marche
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Free and esterified phytosterol ratiothe day of deliveryPlasma 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.

Secondary

MeasureTime frameDescription
total cholesterol concentrationsthe day of deliveryplasma 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.
total lathosterol concentrationsthe day of deliveryplasma 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.
total 7-dehydrocholesterol concentrationsthe day of deliveryplasma 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.
total 7-alpha-hydroxycholesterol concentrationsthe day of deliveryplasma 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.
fatty acid concentrationsthe day of deliveryplasma 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026