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CMECNE

ACOG Guidance on Use of Sulfonamides and Nitrofurantoin for UTIs in the First Trimester

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Learning Objectives and CME/Disclosure Information

This activity is intended for healthcare providers delivering care to women and their families.

After completing this activity, the participant should be better able to:

1. Discuss the ACOG recommendations for use of sulfonamides and nitrofurantoin
2. Describe the potential risks associated with prescribing medications for those individuals who may be at risk for G6PD deficiency

Estimated time to complete activity: 0.25 hours

Faculty:

Susan J. Gross, MD, FRCSC, FACOG, FACMG
President and CEO, The ObG Project

Disclosure of Conflicts of Interest

Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.

Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.

Method of Participation and Request for Credit

Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from March 4 2018 through March 3 2021, participants must read the learning objectives and faculty disclosures and study the educational activity.

If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.

For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.

Joint Accreditation Statement

In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.

Physician Continuing Medical Education

Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Continuing Nursing Education

The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.

Designated for 0.2 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

Read Disclaimer & Fine Print

SUMMARY:  

The CDC reported (MMWR, 2018) raised concern regarding the ongoing use of sulfonamides and nitrofurantoin in the first trimester due to the possible risk for birth defects.  The authors in this paper state the following  

According to 2011 guidelines from the Infectious Diseases Society of America, nonpregnant women with uncomplicated UTIs should be treated with nitrofurantoin or trimethoprim-sulfamethoxazole. For pregnant women in their first trimester, a 2011 Committee Opinion from the American College of Obstetricians and Gynecologists recommended that sulfonamides and nitrofurantoin may be prescribed only if other antimicrobial therapies are deemed clinically inappropriate. In this analysis, 34.7% of pregnant women with UTIs in 2014 filled a prescription for nitrofurantoin and 7.6% filled a prescription for trimethoprim-sulfamethoxazole during their first trimester of pregnancy.

ACOG has replaced Committee opinion 294 (2011) with Committee Opinion 717 (reaffirmed 2019) that still recommends the cautious use of sulfonamides and nitrofurantoin in the first trimester of pregnancy due to possible risk of birth defects, if no other alternatives are available.

Recommendations  

  • Prescribe antibiotics as indicated and for as brief a time as possible  
  • Do not treat presumed contaminants found on urine culture  
    • Mixed gram-positive bacteria | lactobacilli |Staphylococcus species (other than S saprophyticus) 
  • If treating an infection in the first trimester 
    • Discuss with patient risk/benefits and fetal/maternal adverse reactions  
    • Sulfonamides and nitrofurantoin in the first trimester of pregnancy can be used if no other alternatives are available  
  • If treating an infection in the second or third trimester 
    • Sulfonamides and nitrofurantoins may be used as first-line medications  
  • Pregnant women should not be denied appropriate therapy due to serious risks to both mother and fetus 

KEY POINTS:  

Evidence for increased risk for birth defects  

    • Concern about sulfonamides and nitrofurantoin in the first trimester of pregnancy and increased risk for birth defects is derived from a population-based case–control study (Pediatr Adolesc Med, 2009) 
  • Study limitations include 
      • Recall bias: Antibiotic use was obtained from women after pregnancy  
      • Lack of medication confirmation: 35% of patients did not remember the specific antibiotic name  
      • Study design: Observational studies can determine association but not causation (for example indication may be culprit and not medication)  
    • Conflicting results: ACOG has updated this latest guidance with data from a 2013 population-based cohort study that did not confirm this association 

Other antibiotics that are not associated with increased risk for birth defects  

  • Penicillins, cephalosporins erythromycin and quinolones were not associated with increased risk in the 2009 study  
  • ACOG lists the following antibiotics that have not been shown to be associated with increased risk for birth defects 
    • Penicillin  
    • Ampicillin  
    • Cephalosporins  
    • Erythromycin  
    • Augmentin  
    • Pivampicillin  
    • Gentamicin  
    • Oxacillin  
    • Metronidazole  
    • Quinolones 

NOTE: G6PD Deficiency Warning  

    • Sulfonamides and nitrofurantoin are contraindicated in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency or pregnant women who are carriers  
    • G6PD is an X-linked recessive disorder and therefore males, not females, are usually affected 
    • Patients are usually asymptomatic, but significant enzyme deficiency can result in hemolytic anemia, brought about by oxidative stress 
  • Female carriers can be affected by certain triggers such as medications, illness, infection, acidosis or certain foods (fava beans)  

Learn More – Primary Sources:

ACOG Committee Opinion 717: Sulfonamides, Nitrofurantoin, and Risk of Birth Defects

CDC: Antibiotics Dispensed to Privately Insured Pregnant Women with Urinary Tract Infections — United States, 2014

Antibacterial medication use during pregnancy and risk of birth defects: National Birth Defects Prevention Study (Pediatr Adolesc Med, 2009)

Haemolytic anaemia after nitrofurantoin treatment in a pregnant woman with G6PD deficiency

Neonatal outcomes after gestational exposure to nitrofurantoin(Obstet Gynecol, 2013)

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FDA Reviews Fluconazole in Pregnancy
SMFM Releases Statement on Acetaminophen Use in Pregnancy

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OBG Project CME requires a modern web browser (Internet Explorer 10+, Mozilla Firefox, Apple Safari, Google Chrome, Microsoft Edge). Certain educational activities may require additional software to view multimedia, presentation, or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Adobe Flash, Apple QuickTime, Adobe Acrobat, Microsoft PowerPoint, Windows Media Player, or Real Networks Real One Player.

Disclosure of Unlabeled Use

This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

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