Clinical trial NCT05883865: Safety Study of Fenofibrate During Pregnancy
Official title: Safety and Efficacy of Fenofibrate in the Treatment of Pregnant Women With Severe Hypertriglyceridemia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Hypertriglyceridemia During Pregnancy
Keywords: severe hypertriglyceridemia
fenofibrate
pregnancy
Lead sponsor: First People's Hospital of Hangzhou
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 250
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women whose TG level is ≥10mM and cannot be decreased by life interventions.

Brief summary: The purpose of this study is to evaluate the safety of fenofibrate in severe hypertriglyceridemia pregnant women.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 20-45 years pregnant women; TG level ≥10mM； Voluntary signed informed consent (prospective study) or voluntary consent to use of medical information (retrospective analysis)

Exclusion Criteria:

* Evidence of decompensated liver disease; Pregnant women with major organ lesions; Has a history of kidney injury, creatinine clearance \<50ml/min, positive urine protein (\>300mg/L); Combined with other chronic diseases (epilepsy, severe intrahepatic cholestasis of pregnancy, severe preeclampsia, systemic lupus erythematosus, antiphospholipid antibody syndrome); B-ultrasound and other examinations during pregnancy have found fetal malformations, or suggested intrauterine growth retardation, or had birth defects or congenital malformations in the previous pregnancy; Pregnant women are participating in other studies or taking other fibrate lipid-lowering drugs

Primary outcomes:
measure: rate of preterm birth of infants
timeFrame: delivery
measure: Apger score of infants
timeFrame: delivery
measure: body weight of infants
timeFrame: within 1 year after delivery
measure: length of infants
timeFrame: within 1 year after delivery
measure: head circumference of infants
timeFrame: within 1 year after delivery
Secondary outcomes:
measure: placental transfer
timeFrame: delivery
measure: milk penetration
timeFrame: up to 7 days after delivery
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Hangzhou First People's Hospital
state: Zhejiang
Study officials:
References: