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CMECNE

ACOG Responds to ANODE Trial and Antibiotic Use for Operative Vaginal Delivery

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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. Describe the key highlights from the ANODE Trial
2. Discuss the ACOG recommendations for use of antibiotics during operative vaginal delivery and the reasoning behind the guidelines

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 through , 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 0.1 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.

Read Disclaimer & Fine Print

SUMMARY:

ACOG has published a Practice Bulletin (April 2020) that provides guidance on the use of antibiotics in the setting of operative vaginal delivery. The recommendations follow the publication of the ANODE RCT that demonstrated antibiotic prophylaxis reduces the risk of maternal infection following operative vaginal birth. The authors of this trial concluded that “this trial shows clear benefit of a single dose of prophylactic antibiotic after operative vaginal birth, and guidance should be changed to reflect this finding”

Summary of the ANODE Trial

Background and Purpose

  • Knight et al. (Lancet, 2019) investigated whether antibiotic prophylaxis was effective at preventing maternal infection following operative vaginal birth

Methods

  • Blinded, randomized controlled trial (RCT)
    • 27 UK obstetric units
  • Participants
    • ≥16 years who had undergone operative vaginal birth at ≥36 weeks
  • Exposure
    • Single dose IV: 1 g amoxicillin and 200 mg clavulanic acid
    • Administered as soon as possible and no more than 6 h after giving birth
  • Primary outcome
    • Confirmed or suspected maternal infection within 6 weeks of delivery

Results

  • 3,420 women
    • 1,715 in antibiotic group | 1,705 in placebo group
  • Significantly fewer women in the amoxicillin and clavulanic acid group had confirmed or suspected infection
    • 11% of amoxicillin and clavulanic acid group
    • 19% of placebo group
    • Risk ratio (RR) 0.58, (95% CI, 0.49–0.69; p<0.0001)
  • Intervention benefit was also seen at 6 weeks post-delivery with significantly lower proportion of women affected with secondary adverse outcomes such as wound breakdown, perineal infection and pain
  • Forceps and vacuum separately (post-hoc analysis)
    • In both forceps and vacuum, number of women with infection was reduced by approximately 50%

KEY POINTS:

ACOG Response

  • Limitations of the ANODE trial
    • 89% of women received an episiotomy | Assumption that most are mediolateral based on UK setting
    • Therefore, results not necessarily generalizable due to different practice patterns in the US currently vs UK at the time the study was undertaken
    • ACOG states that the

…use of routine prophylactic antibiotics before delivery would not be recommended. Because wound infections and complications are more common in the setting of a third- or fourth-degree laceration, it may be more judicious to consider antibiotics if a third- or fourth-degree laceration occurs”

Learn More – Primary Sources:

ACOG Practice Bulletin 219: Operative Vaginal Birth

Prophylactic antibiotics in the prevention of infection after operative vaginal delivery (ANODE): a multicentre randomised controlled trial

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Related ObG Topics:

Are Number of Pop-Offs, Forcep Pulls or Longer Operative Vaginal Delivery Times Associated with Adverse Neonatal Outcomes?
Mode of Delivery and Risk of Pelvic Floor Disorders, Quantified Over Time
Forceps/Vacuum Delivery vs Cesarean Section and Adverse Maternal and Perinatal Outcomes
ANODE RCT Results: Antibiotic Prophylaxis for Forceps or Vacuum Extraction?

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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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