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Alerts
CMECNE

Alternatives to Indigo Carmine When Diagnosis of PROM is Equivocal

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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. Restate the best available options to diagnose PPROM
2. Discuss the use of sodium fluorescein

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 faculty, planners, and others in control of educational content to disclose all their financial relationships with ineligible companies. All identified conflicts of interest (COI) are thoroughly vetted and mitigated according to PIM policy. PIM is committed to providing its learners with high quality accredited continuing education activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of an ineligible company.

The PIM planners and others have nothing to disclose. The OBG Project planners and others have nothing to disclose.

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 Dec 31 2017 through Jan 25 2023, 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:

Indigo carmine was the dye of choice to definitively diagnose premature rupture of membranes (PROM) for decades. It was also helpful when performing amniocentesis in multifetal gestation to help distinguish the various sacs.  However, availability has been an issue and in response, Ireland et al. (Obstetrics and Gynecology 2017) have written an expert commentary to review alternatives.  The authors conclude that sodium fluorescein and phenol-sulfonphthalein may be the best options (although the latter is not available currently for medical use in the US).

Sodium Fluorescein

Clinical use possible: Recommendation ‘B’ – based on limited or inconsistent scientific evidence

  • Yellow-green fluorescence in alkaline fluids using UV light source
  • Alternative dye for cystoscopy
  • Dose (amnio instillation)
    • 2-5 mL 10% (200 – 500mg)
    • 1-4 ml 5% (50-200 mg) has been suggested as sufficient
  • While there are potential IV side effects such as yellowing of sclera/palms, nausea, emesis and allergic reaction, no adverse events have been reported with amnio instillation
  • Original technique describes speculum exam of cervix at 15 and 45 minutes post injection using a long-wave ultraviolet light
    • Yellow-green fluorescent fluid leaking from cervix confirms the diagnosis
    • Fluorescence will rapidly appear in urine and confusion may be resolved with either visualization of cervical leak or tampon

Phenol-sulfonphthalein

Clinical use possible: Recommendation ‘B’ – based on limited or inconsistent scientific evidence

  • pH indicator dye, also known as phenol red
  • Used for renal blood flow studies
  • Dose (amnio instillation)
    • 1 – 3mL
    • Other studies have confirmed ability of this dye to accurately identify PROM
  • No side effects reported
  • Not currently available in the US for medical use beyond clinical laboratory reagent

Indocyanine Green (emits near-infrared fluorescence when exposed to light)

Clinical use possible but currently experimental: Recommendation ‘C’ – based on consensus or expert opinion

  • Used in the study of cardiac and liver function and ophthalmology
  • No studies on amnio instillation reported
  • Rare anaphylaxis during ophthalmologic studies
  • Further studies required

Phenazopyridine Hydrochloride

Clinical use not recommended: Recommendation ‘D’ – recommendation against the service

  • Also known as Pyridium
  • Oral azo dye, used as a UTI analgesic that stains urine orange/red
  • Dose (amnio instillation)
    • 400 mg orally
  • Crosses placenta with high false positive rate

Evans Blue

Clinical use not recommended: Recommendation ‘D’ – recommendation against the service

  • Azo dye used for plasma volume studies
  • Dose (amnio instillation)
    • 5 mL
  • Amnio instillation resulted in neonatal staining at delivery, persistence in newborn blood and possible muscular/subcutaneous tissue atrophy

Methylene Blue

Clinical use contraindicated: Recommendation ‘D’ – recommendation against the service

  • Cationic thiazine dye resulting in blue color when oxidized
  • Indigo carmine became dye of choice due to known neonatal side effects of intra-amniotic methylene blue which include
    • Hemolysis
    • Hyperbilirubinemia
    • Methemoglobinemia
    • Intestinal obstruction (possibly due to fetal methemoglobinemia, hypoxemia and consequent reduced blood flow to intestinal tract)

Learn More – Primary Sources:

Intra-amniotic Dye Alternatives for the Diagnosis of Preterm Prelabor Rupture of Membranes

A technic for the detection of rupture of the membranes. A review and preliminary report (Sodium Fluorescein)

Locate a Maternal Fetal Medicine Specialist

Maternal Fetal Medicine Specialist Locator-SMFM

Take a post-test and get CME credits

TAKE THE POST TEST

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Related ObG Topics:

What is the Best Course of Action Following PPROM Between 24 and 37 Weeks?
Antenatal Corticosteroids – When to Administer?

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Computer System Requirements

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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