A Cohort Study of Mental Health Services Utilization Following a First Pregnancy Abortion or Birth.

Objective: To determine whether exposure to a first pregnancy outcome of induced abortion, compared to a live birth, is associated with an increased risk and likelihood of mental health morbidity. Materials and methods: Participants were continuously eligible Medicaid beneficiaries age 16 in 1999, and assigned to either of two cohorts based upon the first pregnancy outcome, abortion (n = 1331) or birth (n = 3517), and followed through to 2015. Outcomes were mental health outpatient visits, inpatient hospital admissions, and hospital days of stay. Exposure periods before and after the first pregnancy outcome, a total of 17 years, were determined for each cohort. Findings: Women with first pregnancy abortions, compared to women with births, had higher risk and likelihood of experiencing all three mental health outcome events in the transition from pre- to post-pregnancy outcome periods: outpatient visits (RR 2.10, CL 2.08-2.12 and OR 3.36, CL 3.29-3.42); hospital inpatient admissions (RR 2.75, CL 2.38-3.18 and OR 5.67, CL 4.39-7.32); hospital inpatient days of stay (RR 7.38, CL 6.83-7.97 and OR 19.64, CL 17.70-21.78). On average, abortion cohort women experienced shorter exposure time before (6.43 versus 7.80 years), and longer exposure time after (10.57 versus 9.20 years) the first pregnancy outcome than birth cohort women. Utilization rates before the first pregnancy outcome, for all three utilization events, were higher for the birth cohort than for the abortion cohort. Conclusion: A first pregnancy abortion, compared to a birth, is associated with significantly higher subsequent mental health services utilization following the first pregnancy outcome. The risk attributable to abortion is notably higher for inpatient than outpatient mental health services. Higher mental health utilization before the first pregnancy outcome for birth cohort women challenges the explanation that pre-existing mental health history explains mental health problems following abortion, rather than the abortion itself.

The Enduring Association of a First Pregnancy Abortion with Subsequent Pregnancy Outcomes: A Longitudinal Cohort Study.

Introduction: Multiple abortions are consistently associated with adverse health consequences. Prior abortion is a known risk factor for another abortion. Objective: To determine the persistence of the association of a first-pregnancy abortion with the likelihood of subsequent pregnancy outcomes. Methods: Data was extracted for a study population of 5453 continuously eligible Medicaid beneficiaries in states which funded and reported elective abortions 1999-2015. Women age 16 in 1999 were organized into three cohorts based upon the first pregnancy outcome: abortion, birth, natural loss. Results: Women in the abortion cohort are more likely than those in the birth cohort to experience another abortion rather than a birth or natural loss, and less likely to experience a live birth rather than an abortion or natural loss, for every subsequent pregnancy. The tendency toward abortion (OR 2.99, CL 2.02-4.43) and away from birth (OR 0.49, CL 0.39-0.63) peaks at the sixth pregnancy, but persists throughout the reproductive period ages 16-32. The pattern is reversed, but similarly consistent, for women in the birth cohort. They remain likelier to have another birth rather than an abortion or natural loss in subsequent pregnancies. Compared to the birth cohort, the abortion cohort had 1.35 times as many pregnancies: 4.31 times the abortions, 1.53 times the natural losses, but only 0.52 times the births. They were 4.3 and 5.0 times as likely to have 2-plus and 3-plus abortions, but only 0.47 times and 0.31 times as likely to have 2-plus and 3-plus births. Of the abortion cohort, 37.1% had no births. By contrast, 73.6% of the birth cohort had no abortions. Conclusion: The first-pregnancy abortion maintains a strong and persistent association with the likelihood of another abortion in subsequent pregnancies, enabling a cascade of adverse events associated with multiple abortions.

A Longitudinal Cohort Study of Emergency Room Utilization Following Mifepristone Chemical and Surgical Abortions, 1999-2015.

INTRODUCTION: Existing research on postabortion emergency room visits is sparse and limited by methods which underestimate the incidence of adverse events following abortion. Postabortion emergency room (ER) use since Food and Drug Administration approval of chemical abortion in 2000 can identify trends in the relative morbidity burden of chemical versus surgical procedures. OBJECTIVE: To complete the first longitudinal cohort study of postabortion emergency room use following chemical and surgical abortions. METHODS: A population-based longitudinal cohort study of 423 000 confirmed induced abortions and 121,283 subsequent ER visits occurring within 30 days of the procedure, in the years 1999-2015, to Medicaid-eligible women over 13 years of age with at least one pregnancy outcome, in the 17 states which provided public funding for abortion. RESULTS: ER visits are at greater risk to occur following a chemical rather than a surgical abortion: all ER visits (OR 1.22, CL 1.19-1.24); miscoded spontaneous (OR 1.88, CL 1.81-1.96); and abortion-related (OR 1.53, CL 1.49-1.58). ER visit rates per 1000 abortions grew faster for chemical abortions, and by 2015, chemical versus surgical rates were 354.8 versus 357.9 for all ER visits; 31.5 versus 8.6 for miscoded spontaneous abortion visits; and 51.7 versus 22.0 for abortion-related visits. Abortion-related visits as a percent of total visits are twice as high for chemical abortions, reaching 14.6% by 2015. Miscoded spontaneous abortion visits as a percent of total visits are nearly 4 times as high for chemical abortions, reaching 8.9% of total visits and 60.9% of abortion-related visits by 2015. CONCLUSION: The incidence and per-abortion rate of ER visits following any induced abortion are growing, but chemical abortion is consistently and progressively associated with more postabortion ER visit morbidity than surgical abortion. There is also a distinct trend of a growing number of women miscoded as receiving treatment for spontaneous abortion in the ER following a chemical abortion.

Estimating the Period Prevalence of Mothers Who Have Abortions: A Population Based Study of Inclusive Pregnancy Outcomes.

INTRODUCTION: The prevalence of induced abortion among women with children has been estimated indirectly by projections derived from survey research. However, an empirically derived, population-based conclusion on this question is absent from the published literature. OBJECTIVE: The objective of this study was to describe the period prevalence of abortion among all other possible pregnancy outcomes within the reproductive histories of Medicaid-eligible women in the U.S. METHODS: A retrospective, cross-sectional, longitudinal analysis of the pregnancy outcome sequences of eligible women over age 13 from the 17 states where Medicaid included coverage of most abortions, with at least one identifiable pregnancy between 1999 and 2014. A total of 1360 pregnancy outcome sequences were grouped into 8 categories which characterize various combinations of the 4 possible pregnancy outcomes: birth, abortion, natural loss, and undetermined loss. The reproductive histories of 4,884,101 women representing 7,799,784 pregnancy outcomes were distributed into these categories. RESULTS: Women who had live births but no abortions or undetermined pregnancy losses represented 74.2% of the study population and accounted for 87.6% of total births. Women who have only abortions but no births constitute 6.6% of the study population, but they are 53.5% of women with abortions and have 51.5% of all abortions. Women with both births and abortions represent 5.7% of the study population and have 7.2% of total births. CONCLUSION: Abortion among low-income women with children is exceedingly uncommon, if not rare. The period prevalence of mothers without abortion is 13 times that of mothers with abortion.

Estimating the Period Prevalence of Publicly Funded Abortion to Space Live Births, 1999 to 2014.

INTRODUCTION/OBJECTIVES: Although a majority of women who have an abortion report having 1 or more children, there is no published research on the number of abortions which occur between live births, after a first child but before the last. The objectives of this research, therefore, were to estimate the period prevalence of an induced abortion separating live births in a population of Medicaid eligible enrollees and to identify the characteristics of enrollees significantly associated with the use of abortion to enable child spacing. METHODS: A retrospective, cross-sectional, longitudinal analysis of the pregnancy outcome sequences of eligible enrollees over age 13 from the 17 states where Medicaid included coverage of all abortions, with at least one identifiable pregnancy outcome between 1999 and 2014. Eligibles with a defined sequence of birth-abortion-birth within up to 5 consecutive pregnancies were identified to estimate the number of eligibles who could have practiced birth spacing by abortion. Logistic regression was applied to identify the significant predictor variables of the birth-abortion-birth sequence. RESULTS: There were 50 012 (1.02%) of 4 875 511 Medicaid eligible enrollees exhibited a birth-abortion-birth sequence. Eligibles with the birth-abortion-birth sequence are more likely to be Black than White (OR 2.641, CL 2.581-2.702), less likely to be Hispanic than White (OR 0.667, CL 0.648-0.687), and more likely to have received contraceptive counseling (OR 1.14, CL 1.118-1.163). Increases in months of Medicaid eligibility (OR 1.004, CL 1.003-1.004) and months from first pregnancy to second live birth (OR 1.015, CL 1.015-1.016) are associated with the likelihood of undergoing live births separated by one or more induced abortions. Increases in the age at first pregnancy are associated with a decreased likelihood of the birth-abortion-birth sequence (OR 0.962, CL 0.959-0.964). CONCLUSION: Birth spacing via abortion is uncommon among a low-income population for whom the financial barriers to abortion are somewhat alleviated.

Deaths and Severe Adverse Events after the use of Mifepristone as an Abortifacient from September 2000 to February 2019.

OBJECTIVES: Primary: Analyze the Adverse Events (AEs) reported to the Food and Drug Administration (FDA) after use of mifepristone as an abortifacient. Secondary: Analyze maternal intent after ongoing pregnancy and investigate hemorrhage after mifepristone alone. METHODS: Adverse Event Reports (AERs) for mifepristone used as an abortifacient, submitted to the FDA from September 2000 to February 2019, were analyzed using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAEv3). RESULTS: The FDA provided 6158 pages of AERs. Duplicates, non-US, or AERs previously published (Gary, 2006) were excluded. Of the remaining, there were 3197 unique, US-only AERs of which there were 537 (16.80%) with insufficient information to determine clinical severity, leaving 2660 (83.20%) Codable US AERs. (Figure 1). Of these, 20 were Deaths, 529 were Life-threatening, 1957 were Severe, 151 were Moderate, and 3 were Mild.The deaths included: 9 (45.00%) sepsis, 4 (20.00%) drug toxicity/overdose, 1 (5.00%) ruptured ectopic pregnancy, 1 (5.00%) hemorrhage, 3 (15.00%) possible homicides, 1 (5.00%) suicide, 1 (5.00%) unknown. (Table 1).Retained products of conception and hemorrhage caused most morbidity. There were 75 ectopic pregnancies, including 26 ruptured ectopics (includes one death).There were 2243 surgeries including 2146 (95.68%) D&Cs of which only 853 (39.75%) were performed by abortion providers.Of 452 patients with ongoing pregnancies, 102 (22.57%) chose to keep their baby, 148 (32.74%) had terminations, 1 (0.22%) miscarried, and 201 (44.47%) had unknown outcomes.Hemorrhage occurred more often in those who took mifepristone and misoprostol (51.44%) than in those who took mifepristone alone (22.41%). CONCLUSIONS: Significant morbidity and mortality have occurred following the use of mifepristone as an abortifacient. A pre-abortion ultrasound should be required to rule out ectopic pregnancy and confirm gestational age. The FDA AER system is inadequate and significantly underestimates the adverse events from mifepristone.A mandatory registry of ongoing pregnancies is essential considering the number of ongoing pregnancies especially considering the known teratogenicity of misoprostol.The decision to prevent the FDA from enforcing REMS during the COVID-19 pandemic needs to be reversed and REMS must be strengthened.

Mifepristone Adverse Events Identified by Planned Parenthood in 2009 and 2010 Compared to Those in the FDA Adverse Event Reporting System and Those Obtained Through the Freedom of Information Act.

BACKGROUND: As part of the accelerated approval of mifepristone as an abortifacient in 2000, the Food and Drug Administration (FDA) required prescribers to report all serious adverse events (AEs) to the manufacturer who was required to report them to the FDA. This information is included in the FDA Adverse Event Reporting System (FAERS) and is available to the public online. The actual Adverse Event Reports (AERs) can be obtained through the Freedom of Information Act (FOIA). METHODS: We compared the number of specific AEs and total AERs for mifepristone abortions from January 1, 2009 to December 31, 2010 from 1. Planned Parenthood abortion data published by Cleland et al. 2. FAERS online dashboard, and 3. AERs provided through FOIA and analyzed by Aultman et al. RESULTS: Cleland identified 1530 Planned Parenthood mifepristone cases with specific AEs for 2009 and 2010. For this period, FAERS online dashboard includes a total (from all providers) of only 664, and the FDA released only 330 AERs through FOIA. Cleland identified 1158 ongoing pregnancies in 2009 and 2010. FAERs dashboard contains only 95, and only 39 were released via FOIA. CONCLUSIONS: There are significant discrepancies in the total number of AERs and specific AEs for 2009 and 2010 mifepristone abortions reported in 1. Cleland's documentation of Planned Parenthood AEs, 2. FAERS dashboard, and 3. AERs provided through FOIA. These discrepancies render the FAERS inadequate to evaluate the safety of mifepristone abortions.

Pregnancy Outcome Patterns of Medicaid-Eligible Women, 1999-2014: A National Prospective Longitudinal Study.

INTRODUCTION: The number and outcomes of pregnancies experienced by a woman are consequential determinants of her health status. However, there is no published research comparing the patterns of subsequent pregnancy outcomes following a live birth, natural fetal loss, or induced abortion. OBJECTIVES: The objective of this study was to describe the characteristic patterns of subsequent pregnancy outcomes evolving from each of three initiating outcome events (birth, induced abortion, natural fetal loss) occurring in a Medicaid population fully insured for all reproductive health services. METHODS: We identified 7,388,842 pregnancy outcomes occurring to Medicaid-eligible women in the 17 states which paid for abortion services between 1999-2014. The first known pregnancy outcome for each woman was marked as the index outcome which assigned each woman to one of three cohorts. All subsequent outcomes occurring up to the fifth known pregnancy were identified. Analyses of the three index outcome cohorts were conducted separately for all pregnancy outcomes, three age bands (<17, 17-35, 36+), and three race/ethnicity groups (Hispanic, Black, White). RESULTS: Women with index abortions experienced more lifetime pregnancies than women with index births or natural fetal losses and were increasingly more likely to experience another pregnancy with each subsequent pregnancy. Women whose index pregnancy ended in abortion were also increasingly more likely to experience another abortion at each subsequent pregnancy. Both births and natural fetal losses were likely to result in a subsequent birth, rather than abortion. Women with natural losses were increasingly more likely to have a subsequent birth than women with an index birth. All age and racial/ethnic groups exhibited the characteristic pattern we have described for all pregnancy outcomes: abortion is associated with more subsequent pregnancies and abortions; births and fetal losses are associated with subsequent births. Other differences between groups are, however, apparent. Age is positively associated with the likelihood of a birth following an index birth, but negatively associated with the likelihood of a birth following an index abortion. Hispanic women are always more likely to have a birth and less likely to have an abortion than Black or White women, for all combinations of index outcome and the number of subsequent pregnancies. Similarly, Black women are always more likely to have an abortion and less likely to experience a birth than Hispanic or White women. CONCLUSION: Women experiencing repeated pregnancies and subsequent abortions following an index abortion are subjected to an increased exposure to hemorrhage and infection, the major causes of maternal mortality, and other adverse consequences resulting from multiple separation events.

Improving the Metrics and Data Reporting for Maternal Mortality: A Challenge to Public Health Surveillance and Effective Prevention.

BACKGROUND: The current measuring metric and reporting methods for assessing maternal mortality are seriously flawed. Evidence-based prevention strategies require consistently reported surveillance data and validated measurement metrics. Main Body: The denominator of live births used in the maternal mortality ratio reinforces the mistaken notion that all maternal deaths are consequent to a live birth and, at the same time, inappropriately inflates the value of the ratio for subpopulations of women with the highest percentage of pregnancies ending in outcomes other than a live birth. Inadequate methods for identifying induced or spontaneous abortion complications assure that most maternal deaths associated with those pregnancy outcomes are unlikely to be attributed. Absent the ability to identify all maternal deaths, and without the ability to differentiate those deaths by specific pregnancy outcomes, existing variations in pregnancy outcome-specific maternal deaths are masked by the use of an aggregated (all outcome) numerator. Under these circumstances, clear and accurate data is not available to inform evidence-based preventive strategies. As the result, algorithms applied for analyzing maternal mortality data may return distorted results Conclusion: Improvement in the effectiveness of maternal mortality surveillance will require: mandatory certification of all fetal losses; linkage of death, birth and all fetal loss (induced and natural) certificates; modification of the structure of the overall maternal mortality ratio to enable pregnancy outcome-specific ratio calculations; development of the appropriate ICD codes which are specific to induced and spontaneous abortions; education for providers on identifying and reporting early pregnancy losses; and, flexible information systems and methods which integrate these capabilities and inform users.

Doctors Who Perform Abortions: Their Characteristics and Patterns of Holding and Using Hospital Privileges.

Controversy exists regarding whether doctors who perform abortions should be required to hold hospital admitting privileges, but no research exists as to the extent to which they actually hold and use such privileges. Extensive Internet and government data sources were used to identify and verify abortionists in Florida. All medical and osteopathic abortion doctors who were licensed to practice at any time during the period 2011 to 2016 were included in the study (n = 85). Every abortionist hospital admission of a female patient aged 15 to 44 occurring during the 6-year study period was identified (n = 21 502). Abortionist physicians are 74.1% male, 62% have been in practice for 30 years or longer, 27.1% are graduates of foreign medical schools, and 55.3% are board certified. Nearly half (48.2%) of the abortionists had at least 1 malpractice claim, public complaint, disciplinary action, or criminal charge. Half (50.6%) of the abortionists reported hospital privileges, but only 32 (37.6%) admitted at least 1 patient to a hospital. Seven physicians accounted for 68.2% of all the admissions, and 79.6% of all admissions were related to a live birth. Black was the modal race (47.6%) and Medicaid the most frequent (64.9%) pay source. Nearly one-fifth (19.4%) of admissions came through the emergency department. Physicians who hold hospital privileges are significantly (P < .05) more likely to be board certified and to be approved for Medicaid payment than their colleagues without privileges. Of those doctors who hold and use hospital privileges, the lowest admission volume physicians are significantly less likely to be involved in live births, more likely to admit commercially insured and white inpatients, and much more likely to use the emergency room as the route to hospital admissions for their Medicaid-eligible and black patients. Further study of abortionist physicians is indicated regarding their heterogeneous personal and professional characteristics; their career pathways and practice concentrations; their relative integration with or isolation from peers and the professional network; the importance of black and poor induced abortion patients in their total caseload; and, especially for abortionists without hospital privileges, the means by which their patients requiring emergency care and hospitalization are accommodated.

Defining reality: the potential role of pharmacists in assessing the impact of progesterone receptor modulators and misoprostol in reproductive health.

Medical abortion is increasingly heralded as an ideal method for decreasing maternal mortality in health-care resource-deprived areas and as an answer to the shrinking pool of physicians willing to perform abortions. The advent of progesterone receptor modulators (PRMs) and the recent approval by the Food and Drug Administration of ella (ulipristal) as an emergency contraceptive put pharmacists in the center of abortion controversy. Pharmacists, worldwide, need to be aware of the controversy surrounding the introduction of PRMs, particularly with regard to the effect on health policy, their mechanism of action, associated adverse events, and common off-label uses. Once understood, genuine opportunity exists for pharmacists to serve a fundamental role in positively shaping public health policy.

Analysis of severe adverse events related to the use of mifepristone as an abortifacient.

BACKGROUND: The systematic analysis of morbidity and mortality for the Food and Drug Administration (FDA)-approved medical abortion regimen using mifepristone is possible using data from the FDA's Adverse Event Reporting System. OBJECTIVE: To assess mifepristone's mortality, morbidity, sentinel events, and quality of postmarketing surveillance using mifepristone adverse event reports (AERs). METHODS: Six hundred seven unique mifepristone AERs submitted to the FDA over a 4 year span were coded using the National Cancer Institute's Common Terminology Criteria for Adverse Events. Coding was based only on data in AERs and may underestimate severity and treatment rendered. Two board-certified obstetrician/gynecologists, the authors, made individual evaluations, compared them, and agreed upon final coding. RESULTS: The most frequent AERs were hemorrhage (n = 237) and infection (66). Hemorrhages included 1 fatal, 42 life threatening, and 168 serious cases; 68 required transfusions. Infections included 7 cases of septic shock (3 fatal, 4 life threatening) and 43 cases requiring parenteral antibiotics. Surgical interventions were required in 513 cases (235 emergent, 278 nonemergent). Emergent cases included 17 ectopic pregnancies (11 ruptured). Second trimester viability was documented in 22 cases (9 lost to follow-up, 13 documented fetal outcome). Of the 13 documented cases, 9 were terminated without comment on fetal morphology, 1 was enrolled in fetal registry, and 3 fetuses were diagnosed with serious malformations, suggesting a malformation rate of 23%. CONCLUSIONS: Hemorrhage and infection are the leading causes of mifepristone-related morbidity and mortality. AERs relied upon by the FDA to monitor mifepristone's postmarketing safety are grossly deficient due to extremely poor quality.