Status:
COMPLETED
Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Southern Medical University, China
Conditions:
Chlamydia Trachomatis Infection
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study aims to identify the relationship between genital C. trachomatis and adverse pregnancy outcomes, and investigate whether screening and treatment of genital C. trachomatis in pregnant women ...
Detailed Description
Women recruited for the study will be randomized to the intervention or control groups. Women in the intervention group will be tested in real time for C. trachomatis and Neisseria gonorrhoeae. Patien...
Eligibility Criteria
Inclusion
- pregnant women on their first visit to the hospital (regardless of gestational age);
- aged 18 or above;
- agree to participate and sign an informed consent.
Exclusion
- systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit;
- comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension);
- diagnosed adverse pregnancy outcomes at recruitment (e.g., stillbirth); Women with a previous history of CT or NG and women with a prior adverse outcome will not be excluded. Instead, the investigators will conduct sub-analysis and check whether the intervention has different effects on different groups of pregnant women.
Key Trial Info
Start Date :
May 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03862495
Start Date
May 21 2020
End Date
March 3 2024
Last Update
September 5 2024
Active Locations (2)
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1
Dermatology Hospital of Southern Medical Hospital
Guangzhou, Guangdong, China
2
Nanhai Hospital of Southern Medical University
Guangzhou, Guangdong, China