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The Clinical Conundrum in Managing Preterm Birth: Balancing Historical Trial Results, Society Guidelines, and Clinical Experience with a Contradictory Trial Outcome

The Clinical Conundrum in Managing Preterm Birth: Balancing Historical Trial Results, Society Guidelines, and Clinical Experience with a Contradictory Trial Outcome

Since its approval by the FDA in 2011, 17-OHPC has been used to safely prevent spontaneous preterm birth in women with such a history.

Available credits: 0.25

Time to complete: 15 minutes


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  • Overview

    Despite the results of the PROLONG clinical trial, 17-OHPC was reaffirmed by ACOG and SMFM shortly after the FDA October 2019 Advisory Committee as the “standard of care” for managing women with a history of spontaneous preterm birth, and the importance of this reaffirmation cannot be overemphasized.

    This article defines the historical role of 17-OHPC in the management of preterm birth and identifies clinical trial factors and patient characteristics within the PROLONG trial that may have influenced its results.

  • Disclosure of Conflicts of Interest

    Disclosure of Conflicts of Interest: 

    In accordance with the ACCME Standards for Commercial Support, Global Learning Collaborative (GLC) requires that individuals in a position to control the content of an educational activity disclose all relevant financial relationships with any commercial interest. GLC resolves all conflicts of interest to ensure independence, objectivity, balance, and scientific rigor in all its educational programs.

    Baha M. Sibai, MD
    Professor of Ob/Gyn
    Director, MFM Fellowship Program
    Department of Obstetrics, Gynecology and Reproductive Sciences
    The University of Texas Medical School at Houston
    Houston, TX

    Dr. Sibai has nothing to disclose.

    Reviewers/Content Planners/Authors:

    • Sean T. Barrett has nothing to disclose.
    • Barry A. Fiedel, PhD has nothing to disclose.
    • Amanda Hilferty has nothing to disclose.
    • Robert Schneider, MSW has nothing to disclose.
  • Learning Objectives

    After participating in this educational activity, participants should be better able to:

    • Incorporate strategies for providing optimal clinical management to women at risk for PTB, based on established SMFM, ACOG, and ACNM recommendations.
    • Define the historical role of 17-OHPC in the management of preterm birth.
    • Identify clinical trial factors - patient populations, healthcare systems - that can influence the results of a clinical trial.
  • Target Audience

    This activity is designed to meet the educational needs of Maternal-Fetal Medicine Specialists, Ob/Gyns, Nurse Practitioners, Physician Assistants, and Certified Nurse Midwives.

  • Accreditation and Credit Designation Statements

    Global Learning Collaborative is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

    Global Learning Collaborative designates this enduring material for a maximum of .25 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

  • Provider(s)/Educational Partner(s)

    Omnia Education is the leading provider of education for women’s health professionals. Our activities are recognized nationwide for providing credible, relevant, and practical information on issues impacting the female patient. Additionally, our unique focus has transformed the CME learning environment, and our ability to help learners recognize and overcome barriers to optimal performance and optimal patient outcomes has positioned us as a leader in women’s health education.

  • Commercial Support

    This activity is supported by an independent educational grant from AMAG Pharmaceuticals, Inc.

  • Disclaimer

    The views and opinions expressed in this educational activity are those of the faculty and do not necessarily represent the views of GLC and Omnia Education. This presentation is not intended to define an exclusive course of patient management; the participant should use his/her clinical judgment, knowledge, experience and diagnostic skills in applying or adopting for professional use any of the information provided herein. 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 patients’ conditions and possible contraindications or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities. Links to other sites may be provided as additional sources of information. Once you elect to link to a site outside of Omnia Education you are subject to the terms and conditions of use, including copyright and licensing restriction, of that site.

    Reproduction Prohibited

    Reproduction of this material is not permitted without written permission from the copyright owner.

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