Clinical trial NCT03073538: Screening of Gonococcal and Chlamydial Infections in the Third Trimester
Official title: Screening of Gonococcal and Chlamydial Infections in the Third Trimester
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonococcal Infection
Chlamydia Infections
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 1691
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rates of N. gonorrhoeae and C. trachomatis in the first trimester
timeFrame: first trimester (1-12 weeks gestation)
measure: Rates of N. gonorrhoeae and C. trachomatis in the third trimester
timeFrame: third trimester (29-40 weeks gestation)
Secondary outcomes:
measure: Physician compliance with screening guidelines
timeFrame: first trimester (1-12 weeks gestation) and third trimester (29-40 weeks gestation)
Other outcomes:
Locations:
Study officials:
affiliation: Unity Health Toronto
name: Mark Yudin, MD
role: PRINCIPAL_INVESTIGATOR
References: