CompletedNot Applicable

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

China200 participantsStarted 2020-05-21

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. 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 criteria

✕. 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.

What they're measuring

Response Rate at Recruitment

Timeframe: at the time of enrollment

Compliance to Receive CT or NG Treatment

Timeframe: Within 1 week after the notification of positive test results

Number of Participants Considered as Cured After Treatment

Timeframe: 1 or 3 months after the treatment

Number of Participants With Adverse Pregnancy Outcomes

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT03862495

SponsorUniversity of North Carolina, Chapel Hill

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-03

Results submitted2024-07-10

View on ClinicalTrials.gov More Chlamydia Trachomatis Infection trials