Final Recommendation Statement
Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication
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.
The U.S. Preventive Services Task Force (USPSTF) makes recommendations about the effectiveness of specific clinical preventive services for patients without obvious related signs or symptoms.
It bases its recommendations on the evidence of both the benefits and harms of the service and an assessment of the balance. The USPSTF does not consider the costs of providing a service in this assessment.
The USPSTF recognizes that clinical decisions involve more considerations than evidence alone. Clinicians should understand the evidence but individualize decisionmaking to the specific patient or situation. Similarly, the USPSTF notes that policy and coverage decisions involve considerations in addition to the evidence of clinical benefits and harms.
Gonococcal ophthalmia neonatorum develops in approximately 28% of infants born to women with gonorrheal disease in the United States. Identifying and treating the infection is important because gonococcal ophthalmia neonatorum can result in corneal scarring, ocular perforation, and blindness.
Recognition of Risk Status
The USPSTF recommends that all newborns receive prophylaxis; however, some newborns are at increased risk for gonococcal ophthalmia neonatorum. Newborns at increased risk include those with a maternal history of sexually transmitted infections, substance abuse, or no prenatal care.
Benefits of Risk Assessment and Preventive Medication
There is convincing evidence that blindness due to gonococcal ophthalmia neonatorum has become rare in the United States since the implementation of universal prophylaxis of newborns.
Harms of Risk Assessment and Preventive Medication
There is convincing evidence that universal prophylaxis of newborns is not associated with serious harms.
The USPSTF concludes that there is high certainty that the net benefit is substantial for topical ocular prophylaxis for all newborns for the prevention of gonococcal ophthalmia neonatorum.
Patient Population Under Consideration
This recommendation applies to all newborns.
Prophylactic regimens using 1.0% tetracycline or 0.5% erythromycin ophthalmic ointment are considered equally effective in the prevention of gonococcal ophthalmia neonatorum; however, the only drug approved by the U.S. Food and Drug Administration for this indication is 0.5% erythromycin ophthalmic ointment. Tetracycline ophthalmic ointment and silver nitrate are no longer available in the United States. A 2.5% solution of povidone-iodine may be useful in preventing ophthalmia neonatorum, but it has not been approved for use in the United States at this time.
Prophylaxis should be provided within 24 hours after birth.
The only drug approved by the U.S. Food and Drug Administration for the prevention of gonococcal ophthalmia neonatorum is 0.5% erythromycin ophthalmic ointment. Further research is needed to find safe and effective alternatives to erythromycin. Another area for research is the question of whether risk-based prophylaxis of newborns, based on maternal risk factors, could be as effective as universal prophylaxis.
In 2005, the USPSTF reviewed the evidence on providing ocular prophylaxis for newborns to prevent gonococcal ophthalmia neonatorum, and found no new evidence of harms associated with ocular prophylaxis.1 The benefits of ocular prophylaxis continue to be well established. In 2009, the USPSTF performed an update of the evidence, with a focus on new and substantial evidence on the benefits and harms of ocular prophylaxis.
The USPSTF found no new substantial evidence on the benefits and harms of ocular prophylaxis in newborns, and therefore reaffirms its recommendation that all newborns receive ocular prophylaxis to prevent gonococcal ophthalmia neonatorum. The 2005 recommendation statement and supporting materials can be found at http://www.uspreventiveservicestaskforce.org/uspstf/uspsgono.htm.
Response to Public Comments
A draft of this reaffirmation was posted for public comment on the USPSTF Web site from August 16, 2010 to September 13, 2010. Nineteen comments were received from individuals or organizations. All comments were reviewed in the creation of this final document.
Recommendations of Others
The American Academy of Pediatrics, Centers for Disease Control and Prevention, World Health Organization, Canadian Task Force on Preventive Health Care, American Academy of Family Physicians, and Canadian Paediatric Society all recommend universal ocular prophylaxis of newborns for the prevention of gonococcal ophthalmia neonatorum. 2-7
Members of the U.S. Preventive Services Task Force
Members of the U.S. Preventive Services Task Force* are at the time this recommendation was finalized are Virginia A. Moyer, MD, MPH, Chair (Baylor College of Medicine, Houston, Texas); Michael L. LeFevre, MD, MSPH, Co-Vice Chair (University of Missouri School of Medicine, Columbia, Missouri); Albert L. Siu, MD, MSPH, Co-Vice Chair (Mount Sinai School of Medicine, New York, New York); Kirsten Bibbins-Domingo, PhD, MD (University of California, San Francisco, California); Susan Curry, PhD (University of Iowa College of Public Health, Iowa City, Iowa); Glenn Flores, MD (University of Texas Southwestern, Dallas, Texas); Adelita Gonzales Cantu, RN, PhD (University of Texas Health Science Center, San Antonio, Texas); David Grossman, MD, MPH (Group Health Cooperative, Seattle, Washington); George Isham, MD, MS (HealthPartners Inc., Minneapolis, Minnesota); Rosanne M. Leipzig, MD, PhD (Mount Sinai School of Medicine, New York, New York); Joy A. Melnikow, MD, MPH (University of California Davis Medical Center, Sacramento, California); Bernadette Melnyk, PhD, RN (Arizona State University College of Nursing and Healthcare Innovation, Phoenix, Arizona); Wanda Nicholson, MD, MPH (University of North Carolina School of Medicine, Chapel Hill, North Carolina); Carolina Reyes, MD (University of Southern California, Los Angeles, California); J. Sanford Schwartz, MD (University of Pennsylvania Medical School and the Wharton School, Philadelphia, Pennsylvania); and Timothy Wilt, MD, MPH (University of Minnesota Department of Medicine and Minneapolis Veteran Affairs Medical Center, Minneapolis, Minnesota).
* Members of the Task Force at the time this recommendation was finalized. For a list of current Task Force members, go to http://www.uspreventiveservicestaskforce.org/about.htm.
- U.S. Preventive Services Task Force. Screening for gonorrhea: recommendation statement. Ann Fam Med. 2005;3:263–267.
- American Academy of Pediatrics. Antimicrobial prophylaxis. In: Pickering LK, Baker CJ, Kimberlin DW, Long SS (eds). Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009. p 828.
- Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2006. MMWR. 2006;55(11):1–100.
- World Health Organization. Guidelines for the Management of Sexually Transmitted Infections. Geneva: World Health Organization; 2003. Accessed at http://whqlibdoc.who.int/publications/2003/9241546263.pdf, (PDF Help). on 7 April 2011.
- Goldbloom RB. Prophylaxis for gonococcal and chlamydial ophthalmia neonatorum. In: Canadian Task Force on the Periodic Health Examination. Canadian Guide to Clinical Preventive Care. Ottawa: Health Canada; 1994:pp168-75.
- American Academy of Family Practice. Gonococcal Infection in Neonates, Ocular Topical Medication. Leawood, KS: American Academy of Family Practice; 2010. Accessed at http://www.aafp.org/online/en/home/clinical/exam/f-j.html on 7 April 2011.
Canadian Paediatric Society. Recommendations for the Prevention of Neonatal Ophthalmia. Paediatr Child Health
Internet Citation: Final Recommendation Statement: Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication. U.S. Preventive Services Task Force. December 2016.