Safety Study of Fenofibrate During Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-01

Study Completion Date

2025-12-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study to Evaluate the Safety of Repatha® in Pregnancy

NCT02906124

Hypercholesterolaemia Pregnancy

TERMINATED

Lipid Metabolism in Gestational Diabetes

NCT00534105

Gestational Diabetes Hyperlipidemia

COMPLETED

The Investigation of the Prediction Model and Prevention Strategy of Serious Pregnancy Complications in Hypertensive Disorders of Pregnancy Based on the Chinese Population

NCT05089175

Hypertensive Disorder of Pregnancy Pregnancy Complications

UNKNOWN

A Clinical Care Pathway for Obese Pregnant Women: A Pilot Cluster RCT

NCT02534051

Obesity Pregnancy

COMPLETED NA

Prenatal Screening, Diagnosis and Intrauterine Intervention of Fetal Abnormal Chromosome and Structure in Twins Pregnancy

NCT02982356

Chromosome Abnormality Twin Pregnancy With Antenatal Problem

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Severe Hypertriglyceridemia During Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

fenofibrate group

Women with TG level ≥10mM receive fenofibrate micronized capsule（200mg ，qd）or table（160mg ，qd）for at least 1 week during pregnancy.

Fenofibrate

Intervention Type DRUG

Fenofibrate is orally administrated daily with food for at least 1 week during pregnancy

negative group

Pregnant women with TG level ≥10mM without fenofibrate treatment.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fenofibrate

Fenofibrate is orally administrated daily with food for at least 1 week during pregnancy

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No