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Monitoring of tacrolimus blood concentrations and evaluation of pregnancy outcomes in patients with connective tissue diseases during pregnancy

Monitoring of tacrolimus blood concentrations and evaluation of pregnancy outcomes in patients with connective tissue diseases during pregnancy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500108296
Enrollment
Unknown
Registered
2025-08-27
Start date
2025-09-01
Completion date
Unknown
Last updated
2025-09-01

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

Conditions

connective tissue disease

Interventions

Tacrolimus group:Tacrolimus treatment
Non-tacrolimus group:Non-tacrolimus treatment

Sponsors

The Second Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1 Females aged 18–45 years old. 2 Meet the diagnostic criteria for CTD (including SLE, myositis, antiphospholipid syndrome, Sjögren's syndrome, etc.). 3 Confirmed pregnancy with gestational age less than 12 weeks at the time of enrolment. 4 SLE patients: SLEDAI score >= 4 points, with no other severe complications or meeting the study criteria as assessed by a physician. 5 Have complete clinical data and have signed an informed consent form. 6 Patients with a pregnancy plan or currently trying to conceive. 7 Good compliance and willingness to participate in follow-up visits.

Exclusion criteria

Exclusion criteria: 1 Severe heart, kidney, liver disease, or other immune system disorders. 2 History of latent tuberculosis infection or tumours. 3 Unwillingness to participate in the study or inability to cooperate with sample collection. 4 Other conditions deemed unsuitable for enrolment by the investigator.

Design outcomes

Primary

MeasureTime frame
Tacrolimus blood concentration;Pregnancy outcomes;

Countries

China

Contacts

Public ContactHaili Shen

The Second Hospital of Lanzhou University

shenhl@lzu.edu.cn+86 139 1932 9146

Outcome results

None listed

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