U.S. Food & Drug Administration

Description

This enduring material reviews the latest research on maternal, fetal, and child adverse outcomes for the most severe form of nausea and vomiting of pregnancy, hyperemesis gravidarum. Etiology, treatment, and pre-clinical evidence for novel mechanisms of prevention and therapy will be discussed.

This activity may reference off-label use of FDA-approved products.

References

Fejzo MS, Trovik J, Grooten IJ, Sridharan K, Roseboom TJ, Vikanes Å, Painter RC, Mullin PM. Nausea and vomiting of pregnancy and hyperemesis gravidarum. Nat Rev Dis Primers. 2019 Sep 12;5(1):62. doi: 10.1038/s41572-019-0110-3. PMID: 31515515.
Fejzo MS, MacGibbon KW, Wisner KL. Pregnant, miserable, and starving in 21st century America. AJOG Glob Rep. 2022 Dec 5;3(1):100141. doi: 10.1016/j.xagr.2022.100141. PMID: 36536797; PMCID: PMC9758489.
Fejzo, M. and Mullin, P. (2021) ‘Neurodevelopmental delays and in utero hyperemesis gravidarum.’, in Neuroscience of normal and pathological development. 1st edn. Cambridge, MA: ELSEVIER ACADEMIC PRESS, pp. 229–240.
Fejzo M, Rocha N, Cimino I, Lockhart SM, Petry C, Kay RG, Burling K, Barker P, George AL, Yasara N, Premawardhena A, Gong S, Cook E, Rainbow K, Withers DJ, Cortessis V, Mullin PM, MacGibbon KW, Jin E, Kam A, Campbell A, Polasek O, Tzoneva G, Gribble FM, Yeo G, Lam B, Saudek V, Hughes IA, Ong KK, Perry J, Sutton Cole A, Baumgarten M, Welsh P, Sattar N, Smith G, Charnock Jones DS, Coll AP, Meek CL, Mettananda S, Hayward C, Mancuso N, O'Rahilly S. Fetally-encoded GDF15 and maternal GDF15 sensitivity are major determinants of nausea and vomiting in human pregnancy. bioRxiv [Preprint]. 2023 Jun 4:2023.06.02.542661. doi: 10.1101/2023.06.02.542661. PMID: 37398065; PMCID: PMC10312505.
Fejzo MS, MacGibbon KW, First O, Quan C, Mullin PM. Whole-exome sequencing uncovers new variants in GDF15 associated with hyperemesis gravidarum. BJOG. 2022 Oct;129(11):1845-1852. doi: 10.1111/1471-0528.17129. Epub 2022 Mar 16. PMID: 35218128; PMCID: PMC9546032.

Learning Objectives

Summarize the adverse maternal, fetal, and child outcomes associated with hyperemesis gravidarum (HG).
Discuss the roles of abnormal levels of GDF15 and maternal GDF15 sensitivity in nausea and vomiting in human pregnancy.
Recognize the importance of earlier screening and frequent follow-up for HG.
Recall the need for testing new strategies for prevention and treatment of HG.

Target Audience
This activity is intended for physicians, pharmacists, nurses, and members of the scientific community and interested women's health stakeholders.

Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.

Continuing Education Accreditation

In support of improving patient care, FDA Center for Drug Evaluation and Research 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.

This activity was planned by and for the healthcare team, and learners will receive 1 Interprofessional Continuing Education (IPCE) credit(s) for learning and change.

CME

FDA Center for Drug Evaluation and Research designates this enduring material for a maximum of 1.00 AMA PRA Category 1 Credit(s)^™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

CPE

This knowledge-based activity has been assigned ACPE Universal Activity Number JA0002895-0000-24-029-H99-P for 1.00 contact hour(s).

CNE

FDA Center for Drug Evaluation and Research designates this activity for 1.00 contact hour(s).

Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor. If you do not see your credit reflected on CPE Monitor* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov. *CPE Monitor sets a strict 60-day limit on uploading credits.

Disclosure

Faculty

Fejzo, Marlena, PhD, Assistant Professor, University of Southern California - I have the following relationship(s): NGM Bio - consultant; Materna Biosciences - consultant, founder, stock, CSO

Planning Committee

Bersoff-Matcha, Susan, MD, Deputy Director, OC - nothing to disclose
Shahidzadeh, Rokhsareh, RN, MSN, Senior Regulatory Health Education Specialist, FDA - nothing to disclose
South, Erin, PharmD, Pharmacist, FDA - nothing to disclose

CE Consultation and Accreditation Team

Bueide, Rachel E., MPhil, Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose

Any relationship shown above in italics has been divested within the last 24 months and is therefore considered mitigated.
All relevant financial relationships have been mitigated.

Requirements for Certificate of Completion (Non CE)
Must attend 100% of the activity.

Initial Release Date
January 23, 2024

Expiration Date
January 22, 2027

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