Draft Recommendation Statement
Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication
This opportunity for public comment expired on October 9, 2018 at 8:00 PM EST
Note: This is a Draft Recommendation Statement. This draft is distributed solely for the purpose of receiving public input. It has not been disseminated otherwise by the USPSTF. The final Recommendation Statement will be developed after careful consideration of the feedback received and will include both the Research Plan and Evidence Review as a basis.
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 preventive care 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 decision-making 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.
The prevalence of gonococcal ophthalmia neonatorum ranges from 0.2 to 1.6 cases per 100,000 live births per year.1-3 Gonococcal ophthalmia neonatorum can cause corneal scarring, ocular perforation, and blindness as early as 24 hours after birth.4-6 In the absence of ocular prophylaxis, transmission rates of gonococcal infection from mother to newborn are 30% to 50%.7
In 2011, the USPSTF reviewed the evidence on prophylactic ocular topical medication for all newborns to prevent gonococcal ophthalmia neonatorum and issued an A recommendation.4 The USPSTF has decided to use a reaffirmation deliberation process to update this recommendation. The USPSTF uses the reaffirmation process for well-established, evidence-based standards of practice in current primary care practice for which only a very high level of evidence would justify a change in the grade of the recommendation.8 In its deliberation of the evidence, the USPSTF considers whether the new evidence is of sufficient strength and quality to change its previous conclusions about the evidence.
Benefits of Preventive Medication
The USPSTF found convincing evidence that ocular prophylaxis of newborns with 0.5% erythromycin ophthalmic ointment can prevent gonococcal ophthalmia neonatorum.
Harms of Preventive Medication
The USPSTF found convincing evidence that ocular prophylaxis of newborns with 0.5% erythromycin ophthalmic ointment is not associated with serious harms.
Using a reaffirmation process,8 the USPSTF concludes with high certainty that the net benefit of topical ocular prophylaxis of all newborns to prevent gonococcal ophthalmia neonatorum is substantial.
Draft: Clinical Considerations
Patient Population Under Consideration
This recommendation applies to all newborns.
Erythromycin ophthalmic ointment is considered effective in preventing gonococcal ophthalmia neonatorum.9 Other medications, such as tetracycline ophthalmic ointment and silver nitrate, have been evaluated for the prevention of gonococcal ophthalmia neonatorum but are no longer available in the United States.3 Gentamicin was used during a period of erythromycin shortage, although its use was associated with ocular reactions (chemical conjunctivitis).10 Currently, erythromycin is the only drug approved by the U.S. Food and Drug Administration for gonococcal ophthalmia neonatorum prophylaxis.10 Ocular prophylaxis of newborns is mandated in most states and is considered standard neonatal care.10
Additional Approaches to Prevention
The incidence of gonococcal ophthalmia neonatorum is related to gonococcal infection rates in women of reproductive age.3 Accordingly, screening for and treatment of gonococcal infection in pregnant women is an important strategy for reducing the sexual transmission of gonorrhea and subsequent vertical transmission leading to gonococcal ophthalmia neonatorum. While screening and treatment programs have reduced the incidence of gonorrhea in pregnant women, there are large disparities in access to prenatal care in the Unites States.1, 11 Therefore, ocular prophylaxis remains an important tool in the prevention of gonococcal ophthalmia neonatorum.
The USPSTF recommends screening for gonorrhea in all sexually active women age 24 years and younger and in older women at increased risk for infection, including pregnant women.12 The USPSTF found insufficient evidence to assess the balance of benefits and harms of screening for chlamydia and gonorrhea in men (I statement).12 The Centers for Disease Control and Prevention provides clinical guidance for ocular prophylaxis and treatment of gonococcal ophthalmia neonatorum.9
Draft: Other Considerations
Research Needs and Gaps
The only available drug approved by the U.S. Food and Drug Administration for the prevention of gonococcal ophthalmia neonatorum is 0.5% erythromycin ophthalmic ointment. It is currently unknown whether Neisseria gonorrhoeae has developed resistance to erythromycin ointment in the United States. However, given increased antimicrobial resistance noted in other countries, further research is needed to find safe and effective alternatives to erythromycin. Another area for research is whether risk-based prophylaxis of newborns, based on maternal risk factors, is as effective as universal prophylaxis.
Burden of Disease
Ophthalmia neonatorum is conjunctivitis occurring in infants during the first month of life. Gonococcal ophthalmia neonatorum occurs when gonococcal infection is transmitted to newborns during delivery by mothers infected with N. gonorrhoeae.9 The incidence of gonococcal conjunctivitis in infants is directly related to the incidence of gonorrhea among women of reproductive age.3 Adolescents and young adults have the highest rates of gonorrhea, with incidence peaking at age 19 years (736.2 cases per 100,000 women); among women ages 20 to 24 years, there were 595.5 cases per 100,000 women in 2016.1 Estimated incidence of gonorrhea in pregnant women in the U.S. primary care setting are not available. Although gonococcal infection rates have declined since national screening programs were implemented in the 1970s, reported gonorrhea cases have increased recently, from 109.8 cases to 145.8 cases per 100,000 population from 2014 to 2016, respectively.1 An estimated 6.2% of births in the United States occur among women receiving little to no prenatal care, although rates as high as 20% have been documented in certain populations based on location and race/ethnicity.11
Data based on infant age (<1 year) and specimen source (conjunctiva or eye) indicate there were an estimated 42 infections (≤0.2 cases) per 100,000 live births per year from 2010 to 2015.1, 2 However, limitations in reporting suggest this is an underestimate.13 Using a broader definition that includes cases with unknown, other, or missing specimen sources, the prevalence of gonococcal ophthalmia neonatorum could possibly have been as high as 1.1 to 1.6 cases per 100,000 live births during that time period.3
Untreated gonococcal ophthalmia neonatorum can result in severe and lasting conditions, including corneal scarring, ocular perforation, and blindness.6 There are no contemporary estimates of blindness related to gonococcal ophthalmia neonatorum in the United States. Historical estimates from 19th-century Europe show that gonococcal ophthalmia neonatorum was a major cause of childhood blindness, resulting in corneal damage in 20% and blindness in 3% of infected infants.14, 15 An observational study from Nairobi, Kenya in the 1980s reported that 16% of a series of 64 infants with gonococcal ophthalmia neonatorum had corneal involvement.16
Scope of Review
To reaffirm its 2011 recommendation on ocular prophylaxis for gonococcal ophthalmia neonatorum, the USPSTF commissioned a targeted evidence review.3 The aim of this review was to identify substantial new evidence that was sufficient to change the prior recommendation.4
Benefits of Preventive Medication
Previous USPSTF reviews found convincing evidence that topical ocular prophylaxis can prevent gonococcal ophthalmia neonatorum. The USPSTF found no new data that would change its previous conclusion that prophylactic ocular topical medication is effective in preventing gonococcal ophthalmia neonatorum and related ocular conditions.
Potential Harms of Preventive Medication
The USPSTF found no new data that would change its previous conclusion that there is convincing evidence that topical ocular prophylaxis of all newborns is not associated with serious harms. Possible harms include the potential for antimicrobial resistance to treatment medication.
Estimate of Magnitude of Net Benefit
The USPSTF considered the evidence using a reaffirmation process and found that topical ocular prophylaxis is effective in preventing gonococcal ophthalmia neonatorum and related ocular conditions, with small associated harms and substantial benefit. Therefore, the USPSTF reaffirms its previous conclusion that there is convincing evidence that topical ocular prophylaxis for all newborns provides substantial benefit.
Draft: Reaffirmation of Previous USPSTF Recommendation
This recommendation is a reaffirmation of the USPSTF 20114 recommendation statement. In 199617 and 200518 the USPSTF reviewed the evidence on ocular prophylaxis for gonococcal ophthalmia neonatorum and found that the benefits of screening substantially outweighed the harms. For the current recommendation, the USPSTF commissioned a targeted review to look for substantial new evidence on the benefits and harms of ocular prophylaxis and determined that the net benefit of ocular prophylaxis continues to be well established. The USPSTF found no new substantial evidence that could change its recommendation and, therefore, reaffirms its recommendation to provide prophylactic ocular topical medication for all newborns to prevent gonococcal ophthalmia neonatorum.
Draft: Recommendations of Others
The Centers for Disease Control and Prevention, American Academy of Pediatrics, American College of Obstetricians and Gynecologists, and the World Health Organization all recommend universal topical ocular prophylaxis to prevent gonococcal ophthalmia neonatorum.1, 19, 20 The Canadian Pediatric Society recommends against universal prophylaxis. Several European countries, including Denmark, Norway, Sweden, and the United Kingdom, no longer require universal prophylaxis, instead opting for a prevention strategy of increased screening and treatment of pregnant women.21 In 2017, the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists recommended screening all pregnant women at risk for gonorrhea or who live in a high-prevalence area at the first prenatal visit; women with gonococcal infection should be retested in 3 to 6 months, preferably in the third trimester.19
1. Centers for Disease Control and Prevention. 2016 Sexually Transmitted Diseases Surveillance. https://www.cdc.gov/std/stats16/default.htm. Accessed August 27, 2018.
2. Kreisel K, Weston E, Braxton J, Llata E, Torrone E. Keeping an eye on chlamydia and gonorrhea conjunctivitis in infants in the United States, 2010-2015. Sex Transm Dis. 2017;44(6):356-358.
3. Guirguis-Blake JM, Evans CV, Rushkin M. Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: A Reaffirmation Evidence Update for the U.S. Preventive Service Task Force. Evidence Synthesis No. 173. AHRQ Publication No. 18-05244-EF-1. Rockville, MD: Agency for Healthcare Research and Quality; 2018.
4. U.S. Preventive Services Task Force. Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: U.S. Preventive Services Task Force Reaffirmation Recommendation Statement. Rockville, MD: Agency for Healthcare Research and Quality; 2011.
5. Snowe RJ, Wilfert CM. Epidemic reappearance of gonococcal ophthalmia neonatorum. Pediatrics. 1973;51(1):110-114.
6. Woods CR. Gonococcal infections in neonates and young children. Semin Pediatr Infect Dis. 2005;16(4):258-270.
7. Laga M, Meheus A, Piot P. Epidemiology and control of gonococcal ophthalmia neonatorum. Bull World Health Organ. 1989;67(5):471-477.
8. U.S. Preventive Services Task Force. U.S. Preventive Services Task Force Procedure Manual. https://www.uspreventiveservicestaskforce.org/Page/Name/procedure-manual. Accessed August 27, 2018.
9. Workowski KA, Bolan GA; Centers for Disease Control and Prevention. Sexually transmitted diseases treatment guidelines, 2015. MMWR Recomm Rep. 2015 5;64(RR-03):1-137.
10. Hammerschlag MR. Chlamydial and gonococcal infections in infants and children. Clin Infect Dis. 2011;53(Suppl 3):S99-102.
11. LeFevre ML; U.S. Preventive Services Task Force. Screening for chlamydia and gonorrhea: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(12):902-910.
12. U.S. Preventive Services Task Force. Screening for chlamydia and gonorrhea: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2014;161(12):902-910.
13. Pilling R, Long V, Hobson R, Schweiger M. Ophthalmia neonatorum: a vanishing disease or underreported notification? Eye (Lond). 2009;23(9):1879-1880.
14. Schaller UC, Klauss V. Is Credé's prophylaxis for ophthalmia neonatorum still valid? Bull World Health Organ. 2001;79(3):262-263.
15. Stephenson S. Ophthalmia Neonatorum With Especial Reference to Its Causation and Prevention. London: George Pulman, Ophthalmoscope Press; 1907.
16. Fransen L, Nsanze H, Klauss V, et al. Ophthalmia neonatorum in Nairobi, Kenya: the roles of Neisseria gonorrhoeae and Chlamydia trachomatis. J Infect Dis. 1986;153(5):862-869.
17. U.S. Preventive Services Task Force. Screening for gonorrhea - including ocular prophylaxis in newborns. In: Guide to Clinical Preventive Services: Report of the U.S. Preventive Services Task Force. 2nd ed. Baltimore, MD: Williams & Wilkins; 1996.
18. U.S. Preventive Services Task Force. Screening for gonorrhea: recommendation statement. Ann Fam Med. 2005;3(3):263-267.
19. American Academy of Pediatrics, American College of Obstetricians and Gynecologists. Guidelines for Perinatal Care. 8th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2017.
20. World Health Organization. WHO Guidelines for the Treatment of Neisseria gonorrhoeae. Geneva: World Health Organization;2016.
21. Moore DL, MacDonald NE; Canadian Paediatric Society, Infectious Diseases and Immunization Committee. Preventing ophthalmia neonatorum. Paediatr Child Health. 2015;20(2):93-96.
Internet Citation: Draft Recommendation Statement: Ocular Prophylaxis for Gonococcal Ophthalmia Neonatorum: Preventive Medication. U.S. Preventive Services Task Force. September 2018.