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    Podcast Series: Recurrent Preterm Birth

     

    PODCASTSERIES

    Topic: Recurrent Preterm Birth

    Podcasts:

    IMPORTANT SAFETY AND PRESCRIBING INFORMATION

    ×

    Makena (hydroxyprogesterone caproate injection) is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.

    There is a Limitation of use with Makena: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.

    There is additional safety information you should be aware of for Makena so you and your patients can weigh the benefits and the risks.

    Important safety information for Makena (hydroxyprogesterone caproate injection)

    • Makena should be discontinued if thrombosis or thromboembolism occurs
    • Allergic reactions, including urticaria, pruritus and angioedema, have been reported with the use of Makena or with other products containing castor oil
    • Women receiving Makena should be monitored if they:
      • Are prediabetic or diabetic
      • Have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction
      • Have a history of clinical depression; Makena should be discontinued if depression recurs
      • Develop jaundice; consider whether benefit of use warrants continuation
      • or Develop hypertension
    • Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%)
    • The most common adverse reactions reported in ≥2% of subjects and at a higher rate in the Makena group than in the control group were injection site reactions including (pain [35% vs. 33%], swelling [17% vs. 8%], pruritus [6% vs. 3%], and nodule [5% vs. 2%]), urticaria (12% vs. 11%), pruritus (8% vs. 6%), nausea (6% vs. 5%), and diarrhea (2% vs. 1%)

    See Makena full Prescribing Information at www.makenapi.com

     

    Identifying and Counseling Patients at Risk for Recurrent Preterm Birth

    Presented by:

    David Gandell, MD
    Clinical Professor of Obstetrics and Gynecology
    University of Rochester
    Rochester Gynecologic and Obstetric Associates, P.C.
    Rochester, NY

    &

    Dr. Sean Daneshmand, MD
    Regional Medical Director, Women's Services
    Clinical Professor in the Department of Reproductive Medicine
    University of San Diego, California

    Identifying and Counseling Patients at Risk for Recurrent Preterm Birth

    David Gandell, MD

    Clinical Professor of Obstetrics and Gynecology University of Rochester
    Rochester Gynecologic and Obstetric Associates, P.C. Rochester, NY
    ×

    Dr. Gandell completed his undergraduate education at Northwestern University and received his Medical Degree from Rush Medical College. His residency in Obstetrics and Gynecology was served at Strong Memorial Hospital and the University of Rochester’s associated hospitals. Dr. Gandell is a Board Certified Obstetrician/Gynecologist, and is a Fellow in the American College of Obstetricians and Gynecologists. He is currently in private practice in Rochester, N.Y., with Rochester Gynecologic and Obstetric Associates, P.C. He also holds the position of Clinical Professor of Obstetrics and Gynecology at the University of Rochester. He has special interests in high-risk pregnancies, preterm birth prevention, pregnancy loss, family planning and contraception, sexually transmitted diseases, infertility treatment, menstrual disorders, menopause, sexuality issues, and biopsychosocial medicine.

    Next Author

    Sean Daneshmand, MD

    Clinical Professor in the Department of Reproductive Medicine
    University of San Diego, California
    ×

    Dr. Sean Daneshmand is a practicing Maternal-Fetal medicine specialist in San Diego, CA since 2002. He received his undergraduate education at the University of California, Los Angeles and received his medical degree from New York Medical College. He completed his residence in Ob/Gyn at the University of California, Los Angeles and his fellowship in Maternal-Fetal medicine at the University of California, San Diego. He is also the founder of Miracle Babies, a non-profit organization providing financial assistance to families with newborns in the neonatal intensive care unit with chapters across the United States. He is currently in private practice at the San Diego Perinatal Center with teaching privileges at the University of California, San Diego.

    Previous Author

    Identifying and Counseling Patients at Risk for Recurrent Preterm Birth

    ×

    The goal of this podcast will be to counsel patients who have experienced a singleton spontaneous preterm birth:

    • The definition of preterm birth (focusing on addressing apathy towards late preterm birth)
    • The importance of delivering at full-term (39-40 weeks)
    • Best practices associated with appropriate patient identification
    • Best practices associated with offering Makena to reduce the risk of preterm birth in the indicated patient population

    Improving Women’s Understanding of Recurrent Preterm Birth

    Presented by:

    David Gandell, MD
    Clinical Professor of Obstetrics and Gynecology
    University of Rochester
    Rochester Gynecologic and Obstetric Associates, P.C.
    Rochester, NY

    &

    Kate
    Patient

    Improving Women’s Understanding of Recurrent Preterm Birth

    David Gandell, MD

    Clinical Professor of Obstetrics and Gynecology University of Rochester
    Rochester Gynecologic and Obstetric Associates, P.C. Rochester, NY
    ×

    Dr. Gandell completed his undergraduate education at Northwestern University and received his Medical Degree from Rush Medical College. His residency in Obstetrics and Gynecology was served at Strong Memorial Hospital and the University of Rochester’s associated hospitals. Dr. Gandell is a Board Certified Obstetrician/Gynecologist, and is a Fellow in the American College of Obstetricians and Gynecologists. He is currently in private practice in Rochester, N.Y., with Rochester Gynecologic and Obstetric Associates, P.C. He also holds the position of Clinical Professor of Obstetrics and Gynecology at the University of Rochester. He has special interests in high-risk pregnancies, preterm birth prevention, pregnancy loss, family planning and contraception, sexually transmitted diseases, infertility treatment, menstrual disorders, menopause, sexuality issues, and biopsychosocial medicine.

    Next Author

    Society for Maternal-Fetal Medicine (SMFM) Clinical Guideline on Reducing the Risk of Preterm Birth and Potential Treatment in Certain At-Risk Women

    ×

    The goal of this podcast will be to reinforce the importance of identifying all at-risk patients regardless of prior preterm birth gestational age.


    Society for Maternal-Fetal Medicine (SMFM) Clinical Guideline on Reducing the Risk of Preterm Birth and Potential Treatment in Certain At-Risk Women

    Presented by:

    David Gandell, MD
    Clinical Professor of Obstetrics and Gynecology
    University of Rochester
    Rochester Gynecologic and Obstetric Associates, P.C.
    Rochester, NY

    &

    William M. Gilbert, MD
    Regional Medical Director, Women's Services
    Sutter Health Valley Region & Clinical Professor,
    VCF Series Department of OB/GYN University of California, Davis

    The Society for Maternal Fetal Medicine (SMFM) issued a clinical guideline in 2012 (and reaffirmed it in 2014) for the role of progestogens to reduce the risk of preterm birth.

    David Gandell, MD

    Clinical Professor of Obstetrics and Gynecology University of Rochester
    Rochester Gynecologic and Obstetric Associates, P.C. Rochester, NY
    ×

    Dr. Gandell completed his undergraduate education at Northwestern University and received his Medical Degree from Rush Medical College. His residency in Obstetrics and Gynecology was served at Strong Memorial Hospital and the University of Rochester’s associated hospitals. Dr. Gandell is a Board Certified Obstetrician/Gynecologist, and is a Fellow in the American College of Obstetricians and Gynecologists. He is currently in private practice in Rochester, N.Y., with Rochester Gynecologic and Obstetric Associates, P.C. He also holds the position of Clinical Professor of Obstetrics and Gynecology at the University of Rochester. He has special interests in high-risk pregnancies, preterm birth prevention, pregnancy loss, family planning and contraception, sexually transmitted diseases, infertility treatment, menstrual disorders, menopause, sexuality issues, and biopsychosocial medicine.

    Next Author

    William M. Gilbert, MD

    Regional Medical Director, Women's Services
    Sutter Health Valley Region & Clinical Professor,
    VCF Series Department of OB/GYN University of California, Davis
    ×

    William M. Gilbert, MD is Regional Medical Director, Women's Services, Sutter Health Valley Region and Clinical Professor, Department of OB/GYN University of California, Davis. Dr Gilbert is the author of over 90 Peer reviewed publications and book chapters. His research interests include disorders of Amniotic Fluid Volume, epidemiological research on Maternal Medical Disorders and Quality indicators in Obstetrics. He has received numerous teaching awards of both Medical Students and Residents. He is the founding Co-Director of the Center for Perinatal Medicine and Law at UCDavis which works to educate Medical students, Residents and faculty on aspects of Medical Legal liability by giving interactive departmental Grand Rounds on this topic.

    Previous Author

    Society for Maternal-Fetal Medicine (SMFM) Clinical Guideline on Reducing the Risk of Preterm Birth and Potential Treatment in Certain At-Risk Women

    ×

    The Society for Maternal Fetal Medicine (SMFM) issued a clinical guideline in 2012 (and reaffirmed it in 2014) for the role of progestogens to reduce the risk of preterm birth. The SMFM Clinical Guideline recommends IM HPC weekly injections to reduce the risk of preterm birth for women pregnant with a single baby who have a history of singleton, spontaneous preterm birth ≻ 37 weeks due to preterm labor or PPROM. Despite expert guideline recommendations, many patients at risk are not identified in clinical practice or are not convinced to move forward with therapy. This podcast will review the clinical data, highlight best practices and discuss practical implementation of the guidelines. The podcast should clarify:

    • That the guideline focuses on two distinct risk factors for preterm birth: history of singleton spontaneous PTB and those w/o a history but who have a short cervix.
    • Who may benefit from Makena therapy
    • Separate and distinct patient populations for Makena vs. vaginal progesterone
    • Timing of administration of Makena
    • What to do if a patient is on Makena and develops a short cervix (i.e., continue therapy and consider cerclage)

    Strategies for implementing the SMFM clinical guideline for reducing the risk of preterm birth in women with a history of recurrent preterm birth

    Presented by:

    David Gandell, MD
    Clinical Professor of Obstetrics and Gynecology
    University of Rochester
    Rochester Gynecologic and Obstetric Associates, P.C.
    Rochester, NY

    &

    Jennifer Gudeman, PharmD
    Clinical Professor of Obstetrics and Gynecology
    University of Rochester
    Rochester Gynecologic and Obstetric Associates, P.C.
    Rochester, NY

    The goal of this podcast is to proactively address known barriers to therapy (consider it a barrier buster).

    David Gandell, MD

    Clinical Professor of Obstetrics and Gynecology University of Rochester
    Rochester Gynecologic and Obstetric Associates, P.C. Rochester, NY
    ×

    Dr. Gandell completed his undergraduate education at Northwestern University and received his Medical Degree from Rush Medical College. His residency in Obstetrics and Gynecology was served at Strong Memorial Hospital and the University of Rochester’s associated hospitals. Dr. Gandell is a Board Certified Obstetrician/Gynecologist, and is a Fellow in the American College of Obstetricians and Gynecologists. He is currently in private practice in Rochester, N.Y., with Rochester Gynecologic and Obstetric Associates, P.C. He also holds the position of Clinical Professor of Obstetrics and Gynecology at the University of Rochester. He has special interests in high-risk pregnancies, preterm birth prevention, pregnancy loss, family planning and contraception, sexually transmitted diseases, infertility treatment, menstrual disorders, menopause, sexuality issues, and biopsychosocial medicine.

    Next Author

    Jennifer Gudeman, PharmD

    Vice President, Maternal Health Medical Affairs
    AMAG Pharmaceuticals
    ×

    Jennifer Gudeman graduated summa cum laude with a Bachelor of Pharmacy and magna cum laude with a Doctorate of Pharmacy from St. Louis College of Pharmacy in 1999 and 2000, respectively. Jennifer has worked in retail and hospital pharmacy settings during her education and career, with a focus in the pharmaceutical industry since 2001. During her time at Mallinckrodt Pharmaceutical, Jennifer had responsibilities involving drug information, adverse drug experience reporting and product quality complaints. Jennifer transitioned to KV Pharmaceutical in 2003, moving through a variety of roles of increasing responsibility in medical affairs, for the organization that was renamed Lumara Health in May 2014 and subsequently acquired by Boston-based AMAG Pharmaceuticals. Jennifer is currently vice president, maternal health, medical affairs at AMAG Pharmaceutical. Jennifer co-authored a review paper titled “Potential Risks of Pharmacy Compounding” in the journal Drugs Research and Development. Previously, Jennifer has published on vulvovaginal infections, diagnosis and treatment. Jennifer has provided numerous presentations on various women’s healthcare topics to healthcare professionals and managed care organizations.

    Previous Author

    Strategies for implementing the SMFM clinical guideline for reducing the risk of preterm birth in women with a history of recurrent preterm birth

    ×

    The goal of this podcast is to proactively address known barriers to therapy (consider it a barrier buster). Barriers include:

    • Lack of awareness of SMFM clinical guideline/protocol in place to identify patients for therapy
    • Health inequities
    • Apathy associated with late preterm birth (HCP and patient)
    • Perception that Makena is “out of reach” of patients due to insurance coverage and/or out-of-pocket expense
    • Logistical challenges with receiving the weekly injection

    Awareness and implementation of the SMFM guidelines is low. Based on market research findings from October 2015, familiarity with the guideline is at 65% among MFMs, 33% among OB/GYNs, and 14% among AHPs. The primary barriers to integrating the guidelines into practice include:

    • Cumbersome insurance coverage among the treatments recommended for therapy
    • Different prescribing algorithms used
    • Inconsistent patient insurance coverage

    Causes of health inequities largely break out into four different areas, as has been described in a recent ACOG Committee Opinion on racial and ethnic disparities:

    • Social inequities (income, housing, education and job)
    • Patient-level factors (genetic and epigenetic)
    • Healthcare system factors (lack of universal access to healthcare, discrimination)
    • Practitioner-level factors (implicit bias, communication barriers, cultural mistrust)

    The gestational age of an at-risk woman’s prior preterm birth is taken into consideration when determining if and how IM HPC is offered. An at-risk patient is less likely to receive treatment if she experienced a prior late preterm birth. At the same time, a patient who has experienced a prior late preterm birth may not be aware of her risk and/or may not believe that she is at risk again.

    The gestational age of an at-risk woman’s prior preterm birth is taken into consideration when determining if and how IM HPC is offered. An at-risk patient is less likely to receive treatment if she experienced a prior late preterm birth. At the same time, a patient who has experienced a prior late preterm birth may not be aware of her risk and/or may not believe that she is at risk again.

    AMAG Pharmaceuticals, the company that markets Makena, has programs in place to help proactively address some of the cost associated and logistical barriers to use. Programs include: