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Screening of Gonococcal and Chlamydial Infections in the Third Trimester

Screening of Gonococcal and Chlamydial Infections in the Third Trimester

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03073538
Enrollment
1691
Registered
2017-03-08
Start date
2016-11-30
Completion date
2019-02-28
Last updated
2019-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chlamydia Infections, Gonococcal Infection

Brief summary

Untreated maternal infection with gonorrhea and/or chlamydia can have serious complications in pregnancy and the neonatal period. In Ontario, routine screening for these infections is done in the first trimester of pregnancy, positive cases are treated with antibiotics, and all newborns are given antibiotic eye ointment within 24 hours of birth. Recently, the Canadian Pediatric Society recommended stopping universal prophylaxis for newborns, with instead, focus on screening and treatment of these infections in pregnancy. Given that these infections can occur at any time in pregnancy, and exposure at delivery provides a significant risk to infants, more information is needed about the rates of infection throughout pregnancy and health-care provider compliance with guidelines to make this change without undue risk. With this information optimal timing of testing can be evaluated.

Detailed description

The primary objective of this study is to retrospectively examine the incidence rates of N. gonorrhoeae (NG) and C. trachomatis (CT) in the first and third trimester for the obstetrical population at St. Michael's Hospital over the course of six months. Secondary objectives include (1) feasibility of instituting third trimester screening for sexually transmitted infections, and (2) assessment of physician compliance with Canadian screening and treatment guidelines. This information will help us to deduce the optimal timing of screening for NG and CT in the obstetrical population at St. Michael's Hospital. It is hypothesized that the incidence rates of both NG and CT infections will be low, but that much can be learned from the positive cases in terms of risk factors and optimal timing of screening. Further, the feasibility of screening in the third trimester will offer options for future guidelines.

Interventions

None listed

Sponsors

Unity Health Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Healthy volunteers
No

Inclusion criteria

* all consecutive prenatal patients attending the obstetrical clinic at St. Michael's Hospital for a six-month period from May 1, 2016 to November 1, 2016, inclusive.

Exclusion criteria

* none.

Design outcomes

Primary

MeasureTime frameDescription
Rates of N. gonorrhoeae and C. trachomatis in the first trimesterfirst trimester (1-12 weeks gestation)To examine the incidence rates of N. gonorrhoeae and C. trachomatis in the first trimester of the obstetrical population at St. Michael's Hospital
Rates of N. gonorrhoeae and C. trachomatis in the third trimesterthird trimester (29-40 weeks gestation)To examine the incidence rates of N. gonorrhoeae and C. trachomatis in the third trimester of the obstetrical population at St. Michael's Hospital

Secondary

MeasureTime frameDescription
Physician compliance with screening guidelinesfirst trimester (1-12 weeks gestation) and third trimester (29-40 weeks gestation)Assessment of physician compliance with Canadian screening and treatment guidelines which specify screening at first and third trimester

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026