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A cohort study on the safety and efficacy of topefigestine injection in women at high risk of preeclampsia (PE)

A cohort study on the safety and efficacy of topefigestine injection in women at high risk of preeclampsia (PE)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500114248
Enrollment
Unknown
Registered
2025-12-09
Start date
2025-12-26
Completion date
Unknown
Last updated
2025-12-15

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

Conditions

None listed

Interventions

Subjects who used topecfigestrin injection:NA
Subjects who did not use topperfigestrin injection:NA

Sponsors

The Second Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1) Confirm clinical pregnancy; 2) Serum markers (PLGF, sFlt1 and sFlt-1/PLGF) were tested at 11-16 weeks of pregnancy and evaluated as high-risk of PE.

Exclusion criteria

Exclusion criteria: 1) Pre-baseline diagnosis and treatment data suspected/known fetal chromosomal/structural abnormalities; Note: Baseline diagnosis and treatment data are defined as the most recent result before the PE risk assessment.

Design outcomes

Primary

MeasureTime frame
Incidence of adverse events;The incidence of congenital malformations in the delivered fetus;The changes of biomarkers (PLGF, sFlt1 and sFlt-1/PLGF) before and after administration and the differences of biomarkers between the two groups;—

Secondary

MeasureTime frame
Miscarriage rate;Premature birth rate;—

Countries

China

Contacts

Public ContactFang Wang

The Second Hospital of Lanzhou University

ery_fwang@lzu.edu.cn+86 139 1930 2888

Outcome results

None listed

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