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

Genital Chlamydia Trachomatis Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Randomized Control Trial Pilot Study

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.

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. Patients who test positive for either infection will be linked to physicians at the Center for treatment. For the control group, women will be tested immediately after childbirth or in the event of an adverse pregnancy outcome. In the event of a positive test result, a confirmation test will be run and if positive, the patient will be referred for treatment. The endpoint of the study is defined as either the occurrence of an adverse pregnancy outcome or delivery of a newborn.

Qualitative in-depth interviews will also be conducted with 20 of the women to explore their opinions, attitudes and feedback on the study process. University of North Carolina at Chapel Hill (UNC) investigators will work with the Nanhai Hospital of Southern Medical University and staff at Dermatology Hospital of Southern Medical University to oversee the study.

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.