An observational study in Severe Hypertriglyceridemia During Pregnancy, sponsored by First People's Hospital of Hangzhou. Recruiting at 1 site in China. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-06-01.
Sponsored by First People's Hospital of Hangzhou · Observational
The purpose of this study is to evaluate the safety of fenofibrate in severe hypertriglyceridemia pregnant women.
Due to changes in various hormone levels during pregnancy, triglyceride (TG) levels will increase physiologically. When TG>10mM, the risk of pancreatitis increases, thereby threaten the maternal and fetal health. Therefore, when TG>10mM, in addition to life interventions such as diet and exercise, drug treatment is required. Fenofibrate is the first-line TG-lowering drug, however, information on its safety during pregnancy is insufficient. According to the instruction, fenofibrate can only be used when the benefits outweigh the risks, that is, dietary control cannot effectively reduce TG (>10g/L) and increase the risk of acute pancreatitis in the mother. This study involves two aspects. On the one hand, it evaluates the effect of fenofibrate on pregnancy outcomes through a retrospective study, and on the other hand, it evaluates its effect on children's growth and development, placental penetration, and milk excretion through a prospective study. 200 pregnant women with TG level>10mM exposed to fenofibrate for more than one week will be recruited. The pregnancy outcomes will be compared to the unexposed women with TG level>10mM. 50 TG level>10mM pregnant women will be enrolled on receive fenofibrate treatment between weeks 24-39 of gestation and delivery for more than one week. According to the mother's wishes, maternal blood, cord blood, amniotic fluid at delivery and breast milk through 7 days after delivery will be collected and for fenofibric acid concentration determination. Moreover, in a one-year follow-up, the physical growth parameters of infants will be collected. The primary endpoint is the effect of fenofibrate on pregnancy outcomes and infant physical growth. The secondary endpoint is placental transfer and milk penetration of fenofibric acid.
324 studies on the registry are indexed under Hypertriglyceridemia; 38 are open to participants now.
This study's planned enrollment of 250 is above the median of 150 across 21 observational studies indexed under Hypertriglyceridemia.
Browse Hypertriglyceridemia studies →First People's Hospital of Hangzhou is the lead sponsor of 73 studies on the registry; 28 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women whose TG level is ≥10mM and cannot be decreased by life interventions.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Women with TG level ≥10mM receive fenofibrate micronized capsule（200mg ，qd）or table（160mg ，qd）for at least 1 week during pregnancy.
Drug: Fenofibrate
Pregnant women with TG level ≥10mM without fenofibrate treatment.
Fenofibrate is orally administrated daily with food for at least 1 week during pregnancy
rate of preterm birth of infants
Time frame: delivery
Apger score of infants
Time frame: delivery
body weight of infants
Time frame: within 1 year after delivery
length of infants
Time frame: within 1 year after delivery
head circumference of infants
Time frame: within 1 year after delivery
placental transfer
Ratio of fenofibrate concentrations in cord and maternal blood
Time frame: delivery
milk penetration
fenofibrate concentrations in breast milk up to 7 days after delivery
Time frame: up to 7 days after delivery
Plan to share: No
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First People's Hospital of Hangzhou