Safety Study of Fenofibrate During Pregnancy

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

Detailed Description
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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.

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

Conditions
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Severe Hypertriglyceridemia During Pregnancy

Intervention / Treatment
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* Drug: Fenofibrate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| fenofibrate group<br>Women with TG level ≥10mM receive fenofibrate micronized capsule（200mg ，qd）or table（160mg ，qd）for at least 1 week during pregnancy. | Drug: Fenofibrate<br>* Fenofibrate is orally administrated daily with food for at least 1 week during pregnancy<br>|
| negative group<br>Pregnant women with TG level ≥10mM without fenofibrate treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of preterm birth of infants |  | delivery | 
| Apger score of infants |  | delivery | 
| body weight of infants |  | within 1 year after delivery | 
| length of infants |  | within 1 year after delivery | 
| head circumference of infants |  | within 1 year after delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| placental transfer | Ratio of fenofibrate concentrations in cord and maternal blood | delivery | 
| milk penetration | fenofibrate concentrations in breast milk up to 7 days after delivery | up to 7 days after delivery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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severe hypertriglyceridemia, fenofibrate, pregnancy