Clinical trial NCT03705767: Placental Passage of Free and Esterified Phytosterols in Humans
Official title: The Maternal-fetal Gradient of Free and Esterified Phytosterols in Term Human Pregnancy at Delivery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mother Fetus Relations
Lead sponsor: Università Politecnica delle Marche
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 68
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women

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.


Eligibility criteria: 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

Primary outcomes:
measure: Free and esterified phytosterol ratio
timeFrame: the day of delivery
Secondary outcomes:
measure: total cholesterol concentrations
timeFrame: the day of delivery
measure: total lathosterol concentrations
timeFrame: the day of delivery
measure: total 7-dehydrocholesterol concentrations
timeFrame: the day of delivery
measure: total 7-alpha-hydroxycholesterol concentrations
timeFrame: the day of delivery
measure: fatty acid concentrations
timeFrame: the day of delivery
Other outcomes:
Locations:
Study officials:
References:
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