Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: Female

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 can reduce adverse pregnancy outcomes.

Approximately 200 pregnant women from Nanhai Hospital of Southern Medical University in Guangzhou, China will be enrolled and randomized to the intervention or control group.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborator: Southern Medical University, China
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

1. pregnant women on their first visit to the hospital (regardless of gestational age);

2. aged 18 or above;

3. agree to participate and sign an informed consent.

Exclusion Criteria:

1. systemic or topical vaginal antibiotics use within 2 weeks prior to the first perinatal visit;

2. comorbidities that are known to be related to adverse pregnancy outcomes (e.g., diabetes and hypertension);

3. 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.