Grade: A The USPSTF recommends the service. There is high certainty that the net benefit is substantial. Offer or provide this service.
The USPSTF recommends prophylactic ocular topical medication for all newborns to prevent gonococcal ophthalmia neonatorum.
Frequency of Service
Prophylaxis should be provided within 24 hours after birth. The USPSTF recommends screening for gonorrhea in all sexually active women 24 years and younger and in older women at increased risk for infection, as well as pregnant women.13 The Centers for Disease Control and Prevention provides clinical guidance for ocular prophylaxis and treatment of gonococcal ophthalmia neonatorum.10
Risk Factor Information
No information available.
Patient Population Under Consideration
This recommendation applies to all newborns regardless of gestational age.
Erythromycin ophthalmic ointment is considered effective in preventing gonococcal ophthalmia neonatorum.10 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).11 Povidone-iodine has been proposed for prophylaxis, but there are limited data on its benefits and harms.3 Currently, erythromycin is the only drug approved by the US Food and Drug Administration for the prophylaxis of gonococcal ophthalmia neonatorum.11 Ocular prophylaxis of newborns is mandated in most states6 and is considered standard neonatal care.11
Additional Approaches to Prevention
The rates of gonococcal ophthalmia neonatorum are 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 rates of gonorrhea in pregnant women, there are large disparities in access to prenatal care in the United States.1, 12Risk-based prophylaxis has also been proposed as an alternative strategy for preventing gonococcal ophthalmia neonatorum. Currently, there are no risk-based tools for screening pregnant women and no studies examining the use of risk-based vs universal prophylaxis. 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 24 years and younger and in older women at increased risk for infection, as well as pregnant women.13 The Centers for Disease Control and Prevention provides clinical guidance for ocular prophylaxis and treatment of gonococcal ophthalmia neonatorum.10
In the United States, the rate of gonococcal ophthalmia neonatorum was an estimated 0.4 cases per 100,000 live births per year from 2013 to 2017.1-4 Gonococcal ophthalmia neonatorum can cause corneal scarring, ocular perforation, and blindness as early as 24 hours after birth.5-7 In the absence of ocular prophylaxis, transmission rates of gonococcal infection from mother to newborn are 30% to 50%.8
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.5 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.9 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,9 the USPSTF concludes with high certainty that the net benefit of topical ocular prophylaxis of all newborns to prevent gonococcal ophthalmia neonatorum is substantial.
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, 20,21 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.22 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. In addition, if the result of the first test is negative but the woman is at high risk for gonorrhea, retesting at the beginning of the third trimester is recommended.20 Reaafirmation of Previous USPSTF Recommendation This recommendation is a reaffirmation of the USPSTF 2011 recommendation statement.5 In 199618 and 2005,19 the USPSTF reviewed the evidence on ocular prophylaxis for gonococcal ophthalmia neonatorum and found that the benefits of screening substantially outweigh 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. Other Considerations Research Needs and Gaps The only available drug approved by the US 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.