Evaluating the safety of fenofibrate for pregnant women with severe hypertriglyceridemia
Safety and Efficacy of Fenofibrate in the Treatment of Pregnant Women With Severe Hypertriglyceridemia
This study is testing whether the medication fenofibrate is safe for pregnant women with very high triglyceride levels and how it affects their pregnancy and their children's growth.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 250 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | First People's Hospital of Hangzhou Academic / other |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT05883865 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety of fenofibrate in pregnant women suffering from severe hypertriglyceridemia, defined as triglyceride levels exceeding 10mM. The study will involve both retrospective and prospective analyses, comparing pregnancy outcomes of women treated with fenofibrate to those who are not. It will also evaluate the effects of fenofibrate on children's growth and development, placental penetration, and milk excretion. A total of 200 pregnant women will be recruited, with specific focus on those treated with fenofibrate between weeks 24-39 of gestation.
Who should consider this trial
Good fit: Ideal candidates for this study are pregnant women aged 20-45 with triglyceride levels of 10mM or higher.
Not a fit: Patients with decompensated liver disease, major organ lesions, or other severe chronic conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical safety data on the use of fenofibrate during pregnancy, potentially improving treatment options for severe hypertriglyceridemia.
How similar studies have performed: While there is limited information on the safety of fenofibrate during pregnancy, this study addresses a significant gap in existing literature, making it a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang
- Hangzhou First People's Hospital — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Zhiyuan Ma, PhD
- Email: mazy1990@163.com
- Phone: 18858273870
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.