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A prospevtive clinical study of the prediction and early diagnosis for preeclampsia based on SIRT1

A prospevtive clinical study of the prediction and early diagnosis for preeclampsia based on SIRT1

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300071526
Enrollment
Unknown
Registered
2023-05-17
Start date
2023-06-01
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

preeclampsia

Interventions

Experimental group:Disclosure of SIRT1's serum level
control group:SIRT1's serum level is blinded
Cohort for PE prediction:None
Cohort for SIRT1’s reference value:None

Sponsors

Obstetrics and Gynecology Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Part I: Determination of serum SIRT1 reference range Inclusion criteria: early gestation at our hospital and willingness to deliver at our hospital, no underlying disease, age = 18 years, singleton, signed informed consent at the time of card creation, consent to use the individual's biological specimen for medical research. Part II: Evaluation of the predictive value of serum SIRT1 in early pregnancy for the development of preeclampsia Inclusion criteria: carded at our hospital in early pregnancy and willing to deliver at our hospital, age =18 years, singleton, signed informed consent at carding, and consent to use the individual's biological specimen for medical research. Part III: Whole-group randomized controlled trial with a stepwise design to assess serum SIRT1 levels in patients with suspected pre-eclampsia Inclusion criteria: Pregnant women =18 years of age, 20+0 to 36+6 weeks of gestation, singleton, with suspected preeclampsia (e.g., new or increased hypertension only, or at least one of the following: proteinuria, epigastric pain, headache with visual disturbance, fetal growth retardation, abnormal maternal blood tests), who were admitted to our institution.

Exclusion criteria

Exclusion criteria: Part I: Determination of serum SIRT1 reference range Exclusion criteria: missed visits, transfer for personal factors, termination of pregnancy before 20 weeks of gestation, occurrence of hypertensive disorders of pregnancy. Part II: Assessment of the predictive value of serum SIRT1 in early pregnancy for the development of pre-eclampsia Exclusion criteria: missed visits, transfer for personal factors, termination of pregnancy before 20 weeks of gestation. Part III: Whole-group randomized controlled trial with a stepwise design to assess serum SIRT1 levels in patients with suspected preeclampsia Exclusion criteria: missed visits, personal factor transfer, diagnosis of preeclampsia, HELLP syndrome, or eclampsia.

Design outcomes

Primary

MeasureTime frame
SIRT1;preeclampsia yes or not;the interval from suspective preeclampsia to confirmed preeclampsia;

Secondary

MeasureTime frame
the incidence of the composite adverse maternal and fetal/neonatal outcomes;the use of spasmolytic agents and antihypertension therapy;

Countries

China

Contacts

Public ContactWeirong Gu

Obstetrics and Gynecology Hospital of Fudan University

guweirong@fudan.edu.cn+86 21 3318 9900

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026