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OpenTrials
Completed

NCT Number: NCT03705767

Placental Passage of Free and Esterified Phytosterols in Humans

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.

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Key information

Conditions

Mother Fetus Relations

Age range

20 year–40 year

Sex eligibility

Female

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Free and esterified phytosterol ratio

    Time frame: the day of delivery

    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.

Secondary outcomes

  1. total cholesterol concentrations

    Time frame: the day of delivery

    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.

  2. total lathosterol concentrations

    Time frame: the day of delivery

    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.

  3. total 7-dehydrocholesterol concentrations

    Time frame: the day of delivery

    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.

  4. total 7-alpha-hydroxycholesterol concentrations

    Time frame: the day of delivery

    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.

  5. fatty acid concentrations

    Time frame: the day of delivery

    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.

Sponsors and collaborators

Lead sponsor

Università Politecnica delle Marche

Other

Registry information

Official study title

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

Acronym: PTS

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Oct 15, 2018
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.