N/A
N=200
Genital CT Treatment to Pregnant Women to Prevent Adverse Pregnancy Outcomes: A Pilot RCT
Chlamydia Trachomatis Infection
Bottom Line
View on ClinicalTrials.gov: NCT03862495 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Response Rate at Recruitment — 100; 100 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- C. trachomatis and N. gonorrhoeae (Diagnostic_test); Azithromycin (Drug); Partner notification and treatment (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate at Recruitment |
100; 100 | — |
| PRIMARY Compliance to Receive CT or NG Treatment |
3; 1 | — |
| PRIMARY Number of Participants Considered as Cured After Treatment |
0; 1 | — |
| PRIMARY Number of Participants With Adverse Pregnancy Outcomes |
21; 22 | — |
| SECONDARY Number of Participants Considered as Cured at 1 Month After the Treatment |
1; 1 | — |
| SECONDARY Number of Participants Considered Cured at 3 Months After the Treatment |
1; 1 | — |
| SECONDARY Number of People Who Completed Follow-up |
63; 65 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03862495). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.