The Health Decisions team attending ACOG 2018 – the Annual Clinical and Scientific Meeting in Austin April 27-30 – had a busy, enjoyable and productive week with our colleagues in the OB/GYN community. In keeping with its mission as a women’s health specialty CRO, Health Decisions sponsored and participated in the 5K Run/Walk for Women. Thanks to all who participated, including those in the snapshot. In addition to the fun run, we enjoyed and learned from a rich informational program at ACOG, beginning with the President’s Panel, “The New Postpartum Visit: Beginning of Lifelong Health.” A key theme was the “Fourth Trimester,” the challenging months after childbirth.
ACOG issued a revised ACOG Committee Opinion on Postpartum Care April 23, 2018, as part of an initiative of ACOG President Haywood L. Brown, MD, FACOG to redefine postpartum care. The initiative recognizes that the months following childbirth are critical for the health of both mother and infant and accordingly states that postpartum care should be viewed as an ongoing process. This means replacing a single six-week follow-up visit with a process of care that includes at least two office visits and medical services that address individual needs. Upon issuance of the new Committee Opinion, Dr. Brown stated, “This revised guidance is important because the new recommended structure is intended to consider and cater to the postpartum needs of all women, including those most at risk of falling out of care. As the nation’s leading group of physicians providing health care for women, we must use the postpartum period as a gateway opportunity to counsel women on long-term health implications.”
Andrea S. Lukes, MD, MHSc, FACOG, Health Decisions’ Chief Medical Officer, commented, “The new ACOG Committee Opinion on the postpartum period is important and welcome. Postpartum depression alone affects approximately one woman in seven. Viewing care during the postpartum months as an ongoing process rather than an isolated follow-up visit has the potential to improve healthcare outcomes for both women and infants.”
Health Decisions CMO Andrea Lukes Presents on Uterine Fibroids and Heavy Menstrual Bleeding
During ACOG, Dr. Lukes gave an e-poster on an investigational treatment option for another important indication in women’s health, uterine fibroids. Dr. Lukes is an expert on Heavy Menstrual Bleeding (HMB), an indication often associated with uterine fibroids. She closely monitors the development of new treatments for HMB, consults with industry and serves as a Principal Investigator in related trials. Dr. Lukes’ interests encompass the development of new drugs for HMB as well as new devices and procedures.
“HMB adversely affects the health and quality of life of many women and profoundly affects women with bleeding disorders,” Dr. Lukes said. “There is room for improvement in available treatments. I am always pleased to see and support development activity in this area.” Dr. Lukes frequently publishes and presents on HMB. Her next scheduled event that focuses on HMB is a complimentary webinar, “Heavy Menstrual Bleeding: Medical Background and PI and Patient Perspectives on Clinical Trials,” Tuesday, May 15, 2018, at 1 pm EDT / 10 am PDT.
“Clinical trials of investigational products for heavy menstrual bleeding have unique requirements, ” Dr. Lukes said. “This includes endpoints based on the alkaline hematin method of assessing blood loss and associated operational challenges. Anyone planning an HMB study should consider the potential challenges in these studies from both the PI and patient perspectives.”
The webinar will include a clinical overview of HMB that covers anatomical and nonanatomical disorders associated with HMB as well as bleeding disorders and differences between clinical trials that include and exclude women with bleeding disorders. Discussion of requirements for clinical trials will include strategies for patient recruitment, prescreening, screening and retention. In addition, a patient who participated in an HMB trial will share her experiences. The webinar will conclude with a Q&A for the audience with Dr. Lukes and the participating patient.