Screening of Gonococcal and Chlamydial Infections in the Third Trimester

Chlamydia Infections Clinical Trial

Official title:

Screening of Gonococcal and Chlamydial Infections in the Third Trimester

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03073538
• Other study ID #: 16-337
• Status: Completed
• Start date: November 2016
• Est. completion date: February 2019

Study information

• Verified date: February 2019
• Source: St. Michael's Hospital, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1691
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Chlamydia Infections
• Communicable Diseases
• Gonococcal Infection
• Gonorrhea
• Infection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rates of N. gonorrhoeae and C. trachomatis in the first trimester	To examine the incidence rates of N. gonorrhoeae and C. trachomatis in the first trimester of the obstetrical population at St. Michael's Hospital	first trimester (1-12 weeks gestation)
Primary	Rates of N. gonorrhoeae and C. trachomatis in the third trimester	To examine the incidence rates of N. gonorrhoeae and C. trachomatis in the third trimester of the obstetrical population at St. Michael's Hospital	third trimester (29-40 weeks gestation)
Secondary	Physician compliance with screening guidelines	Assessment of physician compliance with Canadian screening and treatment guidelines which specify screening at first and third trimester	first trimester (1-12 weeks gestation) and third trimester (29-40 weeks gestation)