Evidence Summary

Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication

January 29, 2019

Recommendations made by the USPSTF are independent of the U.S. government. They should not be construed as an official position of the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services.

By Janelle M. Guirguis-Blake, MD; Corinne V. Evans, MPP; and Megan Rushkin, MPH

The information in this article is intended to help clinicians, employers, policymakers, and others make informed decisions about the provision of health care services. This article is intended as a reference and not as a substitute for clinical judgment.

This article may be used, in whole or in part, as the basis for the development of clinical practice guidelines and other quality enhancement tools, or as a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

This research letter was published in JAMA on January 29, 2019.

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Gonococcal ophthalmia neonatorum (GON) is a neonatal conjunctival infection transmitted intrapartum from mothers infected with Neisseria gonorrhoeae to their newborns. Although GON is rare in the United States, with 0.4 cases or fewer per 100,000 live births per year during 2013-2017,1 prevention remains important because of high risk of corneal perforation and blindness, which can develop within 24 hours after delivery.2

Preventive strategies for GON include screening for and treatment of gonorrhea in pregnant women and ocular prophylaxis in newborns, which is mandated in most states. Since 1996, the US Preventive Services Task Force (USPSTF) has maintained an “A” recommendation for prophylactic ocular topical medication for all newborns for the prevention of GON, based on good evidence that blindness due to GON has become rare in the United States since the implementation of universal preventive medication of infants. This brief evidence update was used by the USPSTF to update its 2011 “A” recommendation.3

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Because ocular prophylaxis for GON represents a long-established standard of practice, the USPSTF commissioned a targeted review using a reaffirmation updating process to identify “new and substantial evidence sufficient enough to change the prior recommendation."4 As such, only the interval evidence since the previous systematic review was evaluated. An analytic framework and  key questions guided the evidence update (Figure). Detailed methods, including the search strategy, inclusion and exclusion criteria, criteria for critical appraisal, and a list of excluded studies, are available in the full evidence report at http://www.uspreventiveservicestaskforce.org/Page/Document/UpdateSummaryFinal/ocular-prophylaxis-for-gonococcalophthalmia-neonatorum-preventive-medication1.

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PubMed and the Cochrane Central Register of Controlled Trials were searched from January 1, 2008, to January 16, 2018. Two reviewers independently reviewed 282 unique citations and 6 full-text articles.

No new publications meeting eligibility criteria were identified.

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This systematic review yielded no relevant new studies since the previous USPSTF recommendation addressing the effectiveness and harms of GON prophylaxis (Table).3 The foundational evidence for prior USPSTF recommendations largely consisted of observational studies from sub-Saharan Africa conducted in the 1980s and 1990s. Given the low prevalence of maternal gonorrhea in developed countries, any contemporary study conducted in a developed country would be underpowered. Comparative effectiveness studies, including one conducted in the United States, have found no statistically significant differences in efficacy for GON prevention with different agents, including silver nitrate, erythromycin, tetracycline, and povidone iodine, although conclusions are limited by low power.5

Although the USPSTF and other bodies recommend universal GON prophylaxis based on the foundational evidence, others, such as the Canadian Pediatric Society, have questioned the current applicability of such evidence because the universal prenatal screening and treatment of sexually transmitted infections introduced in the 1970s is considered the most effective preventive strategy and the standard of care. It is possible that state-mandated ocular prophylaxis may be less warranted in settings with comprehensive access to prenatal care, including screening pregnant women for gonorrhea and addressing infections before birth. However, not all US women receive prenatal care. In the United States, where risk-based prenatal gonorrhea screening is recommended and ocular prophylaxis is the standard of care, the individual contribution of each method for preventing GON is unknown.

The ideal candidate agent for prophylaxis would be effective against GON but with low risk of antibiotic resistance, not cause chemical conjunctivitis, be inexpensive in single-dose vials, and be approved by the US Food and Drug Administration and available in the United States. Currently, erythromycin fulfills most of these criteria, but some concerns remain about potential antibiotic resistance6 and data on the incidence of chemical conjunctivitis with erythromycin agents are scarce.

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Source: This article was first published in the Journal of the American Medical Association on January 29, 2018 (JAMA. 2019;321(4):404-406).

Conflict of Interest Disclosures: None reported.

Funding/Support: This research was funded under contract HHSA-290-2015-00007-I, Task Order 5, from the Agency for Healthcare Research and Quality (AHRQ), US Department of Health and Human Services, under a contract to support the USPSTF.

Role of the Funder/Sponsor: Investigators worked with USPSTF members and AHRQ staff to develop the scope, analytic framework, and key questions for this review. AHRQ had no role in study selection, quality assessment, or synthesis. AHRQ staff provided project oversight, reviewed the report to ensure that the analysis met methodological standards, and distributed the draft for peer review. Otherwise, AHRQ had no role in the conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript findings. The opinions expressed in this document are those of the authors and do not reflect the official position of AHRQ or the US Department of Health and Human Services.

Additional Information: A draft version of the full evidence report underwent external peer review from 4 content experts (Mary Anne Jackson, MD, Kansas City School of Medicine; Margaret Hammerschlag, MD, SUNY Downstate Medical Center; Dorothy Moore, MD, SUNY Downstate Medical Center; and Angela Myers, MD, MPH, University of Missouri–Kansas City School of Medicine) and 3 federal partners (Bill G. Kapogiannis, MD, National Institutes of Health [NIH]; Brandy Peaker, MD, MPH, Centers for Disease Control and Prevention; and Carmelle Norice-Tra, MD, PhD, NIH). Comments from reviewers were presented to the USPSTF during its deliberation of the evidence and were considered in preparing the final evidence review. Peer reviewers and those commenting on behalf of partner organizations did not receive financial compensation for their contributions.

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  1. Centers for Disease Control and Prevention (CDC). STDs in women and infants. CDC website. https://www.cdc.gov/std/stats17/womenandinf.htm. Updated July 24, 2018. Accessed November 26, 2018.
  2. Kapoor V, Whyte R, Vedula S. Interventions for preventing ophthalmia neonatorum. Cochrane Database Syst Rev. 2016;(9):CD001862. http://onlinelibrary.wiley.com/doi/001810.001002/14651858.CD14001862.pub14651853/pdf.
  3. U.S. Preventive Services Task Force. Ocular prophylaxis for gonococcal ophthalmia neonatorum: reaffirmation recommendation statement. Am Fam Physician. 2012;85(2):195-196.
  4. Mabry-Hernandez I, Oliverio-Hoffman R. Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Evidence Update for the U.S. Preventive Services Task Force Reaffirmation Recommendation Statement. Rockville, MD: Agency for Healthcare Research and Quality; 2010.
  5. Hammerschlag MR, Cummings C, Roblin PM, Williams TH, Delke I. Efficacy of neonatal ocular prophylaxis for the prevention of chlamydial and gonococcal conjunctivitis. N Engl J Med. 1989;320(12):769-772.
  6. Public Health Agency of Canada, National Microbiology Laboratory. National surveillance of antimicrobial susceptibilities of Neisseria gonorrhoeae—2015. Government of Canada website. https://www.canada.ca/en/public-health/services/publications/drugs-health-products/national-surveillance-antimicrobial-susceptibilities-neisseria-gonorrhoeae-annual-summary-2015.html. Modified November 6, 2017. Accessed June 5, 2018.
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Figure displays the literature search results and article flow for the review. A total of 282 abstracts were screened and 6 full-text articles were assessed for eligibility. No new studies were identified.

Evidence reviews for the US Preventive Services Task Force (USPSTF) use an analytic framework to visually display the key questions that the review will address to allow the USPSTF to evaluate the effectiveness and safety of a preventive service. The questions are depicted by linkages that relate to interventions and outcomes. A dashed line depicts a health outcome that follows an intermediate outcome. Further details are available from the USPSTF Procedure Manual.

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Rationale for Previous GON Prophylaxis USPSTF Recommendation3 and Foundational Evidence Limitations of Foundational Evidence New Evidence Findings
Consistent evidence that topical ocular prophylactic preparations including erythromycin (0.5% ophthalmic ointment), tetracycline (1% ophthalmic ointment), and 1% silver nitrate solution are effective in preventing GON

Strong evidence that universal administration of ocular prophylaxis has reduced incidence of GON in the United States

Primarily based on observational evidence from studies conducted in countries with limited applicability to the United States >20 years ago

Limited evidence evaluating comparative effectiveness of prophylactic preparations that do not rely on antibiotics (ie, povidone-iodine)

No new studies identified for clinical effectiveness

Few new studies identified evaluating comparative effectiveness of prophylactic agents from countries with limited applicability to the United States; 1 study from Israel using 2003-2004 data found no difference between iodine and tetracyclinein reducing in GON cases

Harms not discussed Reporting of harms is sparse and nonspecific, generally indicating the occurrence of chemical conjunctivitis, particularly with the use of silver nitrate No new harms studies identified

Abbreviations: GON, gonococcal ophthalmia neonatorum; USPSTF, US Preventive Services Task Force.

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