ACNM provides clinical information to FDA on pools/tubs indicated for use during the birthing process
ACNM representatives were invited to a meeting on November 16 to provide clinical information to the Food & Drug Administration (FDA) on the benefits and risks of pools/tubs indicated for use during the birthing process. Jenna Shaw-Battista, CNM, PhD, program director for the University of California at San Francisco/San Francisco General Hospital Interdepartmental Nurse-Midwifery Education Program, and Tina Johnson, CNM, MS, ACNM Director of Professional Practice & Health Policy, attended for ACNM. Also in attendance were representatives from the American Association of Birth Centers (AABC), the Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN), the Midwives Alliance of North America (MANA), and the National Association of Certified Professional Midwives (NACPM), as well as the American Academy of Pediatrics (AAP), the American College of Obstetricians and Gynecologists (ACOG), the American Hospital Association (AHA), and the Society for Maternal-Fetal Medicine (SMFM).
Pools/tubs which are labeled as “birthing pools/tubs” or “labor pools/tubs” are medical devices and are subject to regulation under the FDA’s Center for Devices and Radiological Health. The FDA was interested in trends in water immersion during labor and delivery in the United States, research on risks and benefits to mothers and newborns, credentialing programs, and the clinical management of underwater birth, including experience with both general purpose pools/tubs and those marketed for use during labor and birth. Dr. Shaw-Battista has researched water labor/birth extensively, and was the primary expert informing the FDA on the state of the science. Her research on water birth will be published next year, and will add considerably to the existing body of evidence.
AABC and MANA provided critical testimony on years of data on safe water birth outcomes, and along with AWHONN and NACPM, provided extensive personal and organizational experience, birth center statistics, and the role of nurses and midwives in supporting women’s options for childbirth and promoting normal physiologic birth. ACOG and AAP reaffirmed their support of the AAP position that “underwater birth should be considered an experimental procedure that should not be performed except within the context of an appropriately designed randomized controlled trial after informed parental consent;” however, none of the physician organizations or the AHA contributed any research, data, or experience to the discussion. ACNM and our midwifery and nursing colleagues will continue to collaborate and inform the regulatory process, which will include an FDA decision on classification and approval of pools/tubs indicated for use during the birthing process.