Severe Hypertriglyceridemia During PregnancyNCT05883865
Safety Study of Fenofibrate During Pregnancy
An observational study of Severe Hypertriglyceridemia During Pregnancy, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of fenofibrate in severe hypertriglyceridemia pregnant women. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Severe Hypertriglyceridemia During Pregnancy
- What is being tested?
- Fenofibrate
- Type of treatment
- Pill or oral medicine
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 1 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women whose TG level is ≥10mM and cannot be decreased by life interventions.
Who may be able to join
- 20-45 years pregnant women; TG level ≥10mM； Voluntary signed informed consent (prospective study) or voluntary consent to use of medical information (retrospective analysis)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310000
Zhiyuan Ma, PhD, 18858273870 ext. 86, mazy1990@163.com
Zhiyuan Ma, PhD
About this study
Official title: Safety and Efficacy of Fenofibrate in the Treatment of Pregnant Women With Severe Hypertriglyceridemia
The purpose of this study is to evaluate the safety of fenofibrate in severe hypertriglyceridemia pregnant women.
Read the 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.
- Being tested
- Fenofibrate
- Keywords
- severe hypertriglyceridemia, fenofibrate, pregnancy
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FenofibrateDrug
Fenofibrate is orally administrated daily with food for at least 1 week during pregnancy
| Study group | Role | What they receive |
|---|---|---|
| fenofibrate group | Women with TG level ≥10mM receive fenofibrate micronized capsule（200mg ，qd）or table（160mg ，qd）for at least 1 week during pregnancy. Receives: Drug: Fenofibrate | |
| negative group | Pregnant women with TG level ≥10mM without fenofibrate treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of preterm birth of infants
Measured: delivery
Apger score of infants
Measured: delivery
body weight of infants
Measured: within 1 year after delivery
length of infants
Measured: within 1 year after delivery
head circumference of infants
Measured: within 1 year after delivery
Secondary outcomes (2)
placental transfer
Ratio of fenofibrate concentrations in cord and maternal blood
Measured: delivery
milk penetration
fenofibrate concentrations in breast milk up to 7 days after delivery
Measured: up to 7 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Jun 2022
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe Hypertriglyceridemia During PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883865
- Sponsor's protocol ID
- IIT-20221208-0197-01
- Status last verified
- Apr 2023
- First submitted
- 17 May 2023
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Fenofibrate in the Treatment of Pregnant Women With Severe Hypertriglyceridemia
- ClinicalTrials.gov ID
- NCT05883865
- Acronym / sponsor ID
- IIT-20221208-0197-01
- Keywords
- severe hypertriglyceridemia, fenofibrate, pregnancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fenofibrate group | – | Drug: FenofibrateWomen with TG level ≥10mM receive fenofibrate micronized capsule（200mg ，qd）or table（160mg ，qd）for at least 1 week during pregnancy. |
| negative group | – | –Pregnant women with TG level ≥10mM without fenofibrate treatment. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women whose TG level is ≥10mM and cannot be decreased by life interventions.
Key inclusion criteria (1 listed)
- 20-45 years pregnant women; TG level ≥10mM； Voluntary signed informed consent (prospective study) or voluntary consent to use of medical information (retrospective analysis)
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FenofibrateFenofibrate is orally administrated daily with food for at least 1 week during pregnancy | Drug | fenofibrate group |
Primary outcome
rate of preterm birth of infants
Time frame: delivery
Apger score of infants
Time frame: delivery
body weight of infants
Time frame: within 1 year after delivery
length of infants
Time frame: within 1 year after delivery
head circumference of infants
Time frame: within 1 year after delivery
2 secondary outcomes
placental transfer
Time frame: delivery
milk penetration
Time frame: up to 7 days after delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Hypertriglyceridemia During Pregnancy, run by First People's Hospital of Hangzhou at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhiyuan Ma, PhD (18858273870, mazy1990@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of preterm birth of infants (time frame: delivery). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2023.