NCT05883865

Safety Study of Fenofibrate During Pregnancy

Safety and Efficacy of Fenofibrate in the Treatment of Pregnant Women With Severe Hypertriglyceridemia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 250 (estimated)
• Sponsor: First People's Hospital of Hangzhou · Academic / Other
• Sex: Female
• Age: 20 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Severe Hypertriglyceridemia During Pregnancy

Interventions

Type	Name	Description
DRUG	Fenofibrate	Fenofibrate is orally administrated daily with food for at least 1 week during pregnancy

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-06-01
• Completion: 2025-12-01
• First posted: 2023-06-01
• Last updated: 2023-06-01

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study