Screening of Gonococcal and Chlamydial Infections in the Third Trimester

Completed

• Conditions: Gonococcal Infection; Chlamydia Infections

• Registration Number: NCT03073538
• Lead Sponsor: Unity Health Toronto

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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Status Verified: 2019-02
• Primary Completion: 2019-02
• Study Completion: 2019-02
• Last Update Submitted: 2019-02-20
• Last Update Posted: 2019-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 1691

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rates of N. gonorrhoeae and C. trachomatis in the first trimester	first 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 trimester	third 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 Outcome Measures

Name	Time	Method
Physician compliance with screening guidelines	first 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