Severe Hypertriglyceridemia During Pregnancy
Conditions
Keywords
severe hypertriglyceridemia, fenofibrate, pregnancy
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.
Interventions
DRUGFenofibrate
Fenofibrate is orally administrated daily with food for at least 1 week during pregnancy
Sponsors
First People's Hospital of Hangzhou
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Apger score of infants | delivery |
| length of infants | within 1 year after delivery |
| head circumference of infants | within 1 year after delivery |
| rate of preterm birth of infants | delivery |
| body weight of infants | within 1 year after delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| milk penetration | up to 7 days after delivery | fenofibrate concentrations in breast milk up to 7 days after delivery |
| placental transfer | delivery | Ratio of fenofibrate concentrations in cord and maternal blood |
Countries
China
Contacts
Primary ContactZhiyuan Ma, PhD
Outcome results
None listed