CTF Structured Abstract: Gonococcal & Chlamydial Ophthalmia Neonatorum

Canadian Task Force on Preventive Health Care

Structured Abstract

Prophylaxis for Gonococcal and Chlamydial Ophthalmia Neonatorum

Prepared by Richard B. Goldbloom, MD, FRCPC, Department of Pediatrics, Dalhousie University

These recommendations were finalized by the Task Force in September 1990

Objective
Burden of Suffering
Options
Outcomes

Evidence
Values
Benefits, Harms, and Costs
Recommendations

Validation
Sponsors
Selected References

Objective

To make recommendations for prophylaxis for gonococcal and chlamydial ophthalmia neonatorum for infants born in Canada. This is an update of the 1992 Canadian Task Force guideline.

Burden of Suffering

In the absence of preventive measures it is estimated that gonoccocal ophthalamia neonatorum will develop in approximately 28% of infants born to women with gonorrhea. Gonoccocal conjunctivitis is usually severe, and N. gonorrhoeae can penetrate the intact corneal epithelium and cause microbial keratitis, ulceration and perforation. Since 1981 the rate of reported gonorrhea in Canada (about 230 per 100,000) has been steadily decreasing: in 1989 there were 19,110 cases (73 cases per 100,00); 8,421 of the cases involved women aged 15 to 59 years old. In 1989 the Laboratory Centre for Disease Control in Ottawa received reports of 55,186 cases of chlamydial infection across Canada (excluding British Columbia and the Northwest Territories). More than 4 million cases of chlamydial infection occur each year in the U.S., and 115,000 infants are born to women with cervical infection. Chlamydial infection can cause pseudomembranous or membranous conjunctivitis in the newborn that may result in conjunctival scarring and corneal infiltrates.

Options

Prophylactic options include 1% silver nitrate solution or antibiotic ointment (1% tetracycline or 0.5% erythromycin) placed in the conjunctival sac of the newborn soon after birth. Prophylaxis can be routine (legally required for all infants in specific countries) or done after screening the mother for gonorrheal and chlamydial infection during prenatal care.

Outcomes

Conjunctivitis, conjunctival scarring, corneal infiltrates, gonococcal and chlamydial ophthalmia neonatorum, blindness in the infant, side effects of the treatment, and parent-infant bonding. Costs were mentioned.

Evidence

MEDLINE was searched up to 1991 using the MeSH term ophthalmia neonatorum. A report with a full reference list was published in November 1992.

Recommendations were graded as:

A Good evidence to support the recommendation that the condition be specifically considered in a PHE.

B Fair evidence to support the recommendation that the condition be specifically considered in a PHE.

C Poor evidence regarding inclusion or exclusion of the condition in a PHE, but recommendations may be made on other grounds.

D Fair evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE.

E Good evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE.

Quality of evidence was rated according to 5 levels:

I Evidence from at least 1 properly randomized controlled trial (RCT).

II-1 Evidence from well-designed controlled trials without randomization.

II-2 Evidence from well-designed cohort or case-control analytic studies, preferably from more than 1 centre or research group.

II-3 Evidence from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments could also be included here.

III Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees.

Values

The 13-member Task Force of experts in family medicine, geriatric medicine, pediatrics, psychiatry and epidemiology used an evidence-based method for evaluating the effectiveness of preventive health care interventions. Recommendations were not based on cost-effectiveness of options. Patient preferences were not discussed.

Background papers providing critical appraisal of the evidence and tentative recommendations prepared by the chapter author were pre-circulated to the members. Evidence for this topic was presented and deliberated upon in 1- to 2-day meetings from March 1990 to September 1990. Consensus was reached on final recommendations.

Benefits, Harms, and Costs

A controlled trial in South Africa showed that introduction of routine ocular prophylaxis with silver nitrate or erythromycin ointment reduced general ophthalmia neonatorum from 273 to 21 per 100,000 live births. A prospective clinical trial of 12,431 infants showed that three treatments had similar low rates of infection (0.03% for silver nitrate drops, 0.07% for tetracycline ointment and 0.1% for erythromycin ointment). Other trials have shown similar infection rates. Inconsistent and conflicting evidence exists for the costs and effectiveness of these agents in preventing chlamydial ophthalmia neonatorium.

Adverse effects identified in RCTs include decreased eye openness, inhibited visual responses within the first hour after birth, chemical conjunctivitis, other ocular reactions, and possible decreased parent-infant bonding. Silver nitrate drops had more adverse effects than antibiotic ointments.

Recommendations

Recommendation grade [A, B, C, D, E] and level of evidence [I, II-1, II-2, II-3, III] are indicated after each recommendation. Citations in support of individual recommendations are identified in the guideline text.

Good evidence exists for universal prophylactic use of 1% silver nitrate drops or 1% tetracycline or 0.5% erythromycin ointment within 1 hour of birth to prevent gonococcal and chlamydial ophthalmia neonatorum. [A, I, II-1, II-3]. Single-dose ampules are recommended for all agents.

Validation

This report was externally peer reviewed. The American Academy of Pediatrics and the U.S. Centers for Disease Control and Prevention (CDC) recommend ointment or drops containing tetracycline or erythromycin, or 1% silver nitrate solution placed in the eyes of all infants shortly after birth. The CDC and the American College of Obstetricians and Gynecologists recommend obtaining endocervical cultures for N. gonorrheae the first prenatal visit; a second culture is recommended late in the third trimester for women at high risk for acquiring sexually transmitted diseases. The 1989 U.S. Preventive Services Task Force recommended that endocervical culture for gonorrhea be done at the first prenatal visit for all women at high risk and an ophthalmic antibiotic ointment be applied to the eyes of all infants immediately after birth.

Selected References

Source Document

Goldbloom R.B. Prophylaxis for gonococcal and chlamydial ophthalmia neonatorum. In: Canadian Task Force on the Periodic Health Examination. Canadian Guide to Clinical Preventive Health Care. Ottawa: Health Canada, 1994; 168-75.

Other

Canadian Task Force on the Periodic Health Examination: The periodic health examination, 1992, update: 4. Prophylaxis for gonococcal and chlamydial ophthalmia neonatorum. Can Med Assoc J. 1992;147:1449-54.

Link to Full Text of this review

Link to Summary Table of Recommendations of this review

Link to Selected References list of this review

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A	Good evidence to support the recommendation that the condition be specifically considered in a PHE.
B	Fair evidence to support the recommendation that the condition be specifically considered in a PHE.
C	Poor evidence regarding inclusion or exclusion of the condition in a PHE, but recommendations may be made on other grounds.
D	Fair evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE.
E	Good evidence to support the recommendation that the condition be specifically excluded from consideration in a PHE.

I	Evidence from at least 1 properly randomized controlled trial (RCT).
II-1	Evidence from well-designed controlled trials without randomization.
II-2	Evidence from well-designed cohort or case-control analytic studies, preferably from more than 1 centre or research group.
II-3	Evidence from comparisons between times or places with or without the intervention. Dramatic results in uncontrolled experiments could also be included here.
III	Opinions of respected authorities, based on clinical experience, descriptive studies or reports of expert committees.