(B-265) Policy Impact on Pregnancy Registry Participation and Reporting of Maternal/Infant Outcomes

Background: Prospective pregnancy registries monitor the safety of exposure to newly approved medicinal products on maternal and infant outcomes. Their success depends on a representative sample of participants willing to enroll and provide detailed information. However, due to the Dobbs ruling (i.e., reduced access to legal/safe induced abortion) changes in enrollment, loss to follow-up (LTFU), and missing data are anticipated.

Objectives: Our objectives were to review published and/or gray literature to assess the potential impact of the Dobbs ruling on:
1. Pregnancy registry enrollment, loss to follow-up, and missing data
2. Maternal and infant outcomes, particularly in congenital anomalies, a critical outcome in pregnancy registries

Methods: Performed targeted literature reviews (TLRs) of published and/or gray literature. For objective (obj) 1, used variations on the following search terms in published literature: abortion, Dobbs, pregnancy, and prospective registry. Obj. 2, used variations on the following search terms in published and gray literature: abortion, pregnancy termination, maternal/infant health outcome, and congenital abnormalities/anomalies.

Results: The TLR for obj. 1, identified 4 articles, and 1 contained relevant information. In that article, researchers observed a 27.1% reduction in potential enrollment in a registry in states with banned or restricted abortion rights comparing the post- versus pre-Dobbs periods. The TLR for obj. 2 identified 1 article suggesting the Dobbs decision may have an adverse effect on maternal, fetal, and infant outcomes. Using Centers for Disease Control and Prevention monthly national data, 204 excess deaths (10% increase) in infant mortality with congenital anomalies were attributed to after Dobbs compared to the previous 5 years.

Conclusions: Results from obj. 1 TLR suggested a potential decline in registry enrollment. Such reactions may precipitate LTFU in states where safe/legal abortion is not available. Participants who enroll in a registry may be LTFU if they obtain an abortion post-enrollment and they and/or their HCPs decline to provide follow-up data related to the induced abortion due to negative repercussions (e.g., arrest, loss of medical license). Results from the obj. 2 TLR suggested that the Dobbs ruling may result in an increased incidence of adverse maternal, infant and child outcomes. This is further supported by Gemmill et al. who found that the abortion ban in Texas was associated with a 12.9% increase in infant deaths in 2022. More research is needed to fully understand the impact of the Dobbs ruling on pregnancy registry enrollment, LTFU, and the prevalence of maternal and infant outcomes.