Screening of Gonococcal and Chlamydial Infections in the Third Trimester

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.

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Key information

Conditions

Gonococcal Infection Bacterial Infections Bacterial Infections and Mycoses Chlamydia Infections Chlamydiaceae Infections Communicable Diseases Genital Diseases Gonorrhea Gram-Negative Bacterial Infections Infections Neisseriaceae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Bacterial Urogenital Diseases

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Rates of N. gonorrhoeae and C. trachomatis in the first trimester

Time frame: 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

Time frame: 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 outcomes

Physician compliance with screening guidelines

Time frame: 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

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Registry information

Important dates

Study start: 2016
Primary completion: 2019
Study completion: 2019
First posted: Mar 8, 2017
Registry last updated: Feb 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed