Safety Study of Fenofibrate During Pregnancy

Last updated: May 31, 2023
Sponsor: First People's Hospital of Hangzhou
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hypertriglyceridemia

Treatment

Fenofibrate

Clinical Study ID

NCT05883865
IIT-20221208-0197-01
  • Ages 20-45
  • Female

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Evidence of decompensated liver disease; Pregnant women with major organ lesions; Hasa history of kidney injury, creatinine clearance <50ml/min, positive urine protein (>300mg/L); Combined with other chronic diseases (epilepsy, severe intrahepaticcholestasis of pregnancy, severe preeclampsia, systemic lupus erythematosus,antiphospholipid antibody syndrome); B-ultrasound and other examinations duringpregnancy have found fetal malformations, or suggested intrauterine growthretardation, or had birth defects or congenital malformations in the previouspregnancy; Pregnant women are participating in other studies or taking other fibratelipid-lowering drugs

Study Design

Total Participants: 250
Treatment Group(s): 1
Primary Treatment: Fenofibrate
Phase:
Study Start date:
June 01, 2022
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

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