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Study for registration of exposure of ribavirin six months before conception/first trimester and safety of development of offspring

Study for registration of exposure of ribavirin six months before conception/first trimester and safety of development of offspring

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000028705
Enrollment
Unknown
Registered
2020-01-01
Start date
2015-08-01
Completion date
Unknown
Last updated
2024-07-08

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 are taking or have taken ribavirin in early pregnancy (including ribavirin alone or with other medicine in conbination treatment); 2. Pregnant women who have taken ribavirin 6 months before conception (including ribavirin alone, or with other medicine in conbination treatment); 3. Pregnant women who voluntarily participated in the survey with informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant women who don't know the dosage and time; 2. Pregnant women using ribavirin in the second and third trimester of pregnancy; 3. Pregnant women who cannot participate in the survey due to mental illness or physical disability.

Design outcomes

Primary

MeasureTime frame
congenital defect;

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;

Countries

China

Contacts

Public ContactCaihong Zheng

Women's Hospital, School of Medicine, Zhejiang University

chzheng@zju.edu.cn+86 0571 89991730

Outcome results

None listed

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