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Pregnancy Exposure Registry in the first trimester for Levofloxacin and the safety study on the development of offspring followed to adulthood

Pregnancy Exposure Registry in the first trimester for Levofloxacin and the safety study on the development of offspring followed to adulthood

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900028674
Enrollment
Unknown
Registered
2019-12-30
Start date
2015-08-04
Completion date
Unknown
Last updated
2023-08-07

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

Conditions

pregnancy

Interventions

Case series:NA

Sponsors

Women's Hospital School Of Medicine Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. Pregnant women who currently taking or have taken Levofloxacin during the first trimester (include in taking Levofloxacin alone or with other medicine for combination treatment); 2. Pregnant women who volunteered to participate in this study with informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant women who can't provide accurate information of using time and dosage of Levofloxacin; 2. Pregnant women who currently taking or have taken Levofloxacin during the second, third trimesters; 3. Pregnant women with mental illness or physical disability; 4. Women who have completed their pregnancy or women who are planning to become pregnant.

Design outcomes

Primary

MeasureTime frame
congenital defect;birth length;Fetal femur length;

Secondary

MeasureTime frame
spontaneous abortion;induced abortion;adverse events of fetus;premature labour;adverse events of neonatus;birth weight;Apgar scores;adverse events of infant;adverse events of children;adverse events of teenagers;

Countries

China

Contacts

Public ContactZheng Caihong

Women's Hospital School of Medicine Zhejiang University

chzheng@zju.edu.cn+86 571 8999 1730

Outcome results

None listed

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