Hormone-related side effects in new users of a levonorgestrel 52 mg intrauterine device.

BACKGROUND: Although the levonorgestrel 52 mg intrauterine device is locally active and has low systemic hormone exposure, hormonal intrauterine device users sometimes report hormone-related side effects. OBJECTIVE: Evaluate hormone-related adverse event rates among all participants and compare these among those who used combined hormonal or no hormonal contraception in the month before enrollment. STUDY DESIGN: A total of 1714 women aged 16-45 years old received a levonorgestrel 52 mg intrauterine device in a multicenter phase 3 trial to evaluate contraceptive efficacy and safety for up to 10 years. This analysis evaluated a subset of participants who used combined hormonal or no hormonal contraception in the month prior to device placement. We assessed all non-expulsion, non-bleeding-related events with ≥1% incidence at 180 days with a plan to include weight increase regardless of incidence; we excluded events considered non-hormonal. We computed 180-day side effect frequency rates based on the number of days a side effect was reported during the study period. We created a multivariable model for side effect incidence at 180 days based on age, race, ethnicity, body mass index at enrollment, parity, and contraception use in the month before enrollment. For those side effects with a p-value <0.2 on univariate comparison between combined-hormonal and no-hormonal contraception users, we secondarily evaluated 360-day event rates. RESULTS: Overall, 644 participants used combined hormonal contraception (primarily oral [n=499, 77.5%]) and 855 used no hormonal method before IUD placement. Individual side effect rates over the first 180 days did not differ between prior combined-hormonal and no-hormonal contraception users except for acne (84 [13.0%] versus 73 [8.5%], respectively), p=0.006, OR 1.61 (95% CI 1.15-2.24). However, this association was weaker after adjustment for age, race, ethnicity, obesity status, and parity (aOR 1.40, 95% CI 0.99-1.98) At 360 days, prior combined hormonal contraception users were more likely to report acne (101 [15.7%] vs. 91 [10.6%], respectively, p=0.005) and orgasm/libido problems (20 [3.1%] vs. 12 [1.4%], respectively, p=0.03). Over the first 180 days, all side effects other than acne were reported in less than 3% of days; acne was reported an average of 13 days (7.4%) per prior combined hormonal contraception user and 9 days (5.0%) per prior non-hormonal contraception user (p<0.0001). Discontinuation for evaluated side effects occurred in 83 (5.5%) participants with no difference between those who used combined hormonal (36 [5.6%]) or no hormonal contraception (47 [5.5%]), p=1.0) before study entry. CONCLUSIONS: Using combined hormonal contraception prior to levonorgestrel 52 mg intrauterine device placement is only weakly associated with reporting hormonally related side effects like acne. Only a small percentage of levonorgestrel 52 mg intrauterine device users experienced potentially hormone-related side effects during the initial 6 months of use that resulted in discontinuation.

Agency in Contraceptive Decision-Making in Patient Care: a Psychometric Measure.

BACKGROUND: Patient agency in contraceptive decision-making is an essential component of reproductive autonomy. OBJECTIVE: We aimed to develop a psychometrically robust measure of patient contraceptive agency in the clinic visit, as a measure does not yet exist. DESIGN: For scale development, we generated and field tested 54 questionnaire items, grounded in qualitative research. We used item response theory-based methods to select and evaluate scale items for psychometric performance. We iteratively examined model fit, dimensionality, internal consistency, internal structure validity, and differential item functioning to arrive at a final scale. PARTICIPANTS: A racially/ethnically diverse sample of 338 individuals, aged 15-34 years, receiving contraceptive care across nine California clinics in 2019-2020. MAIN MEASURES: Contraceptive Agency Scale (CAS) of patient agency in preventive care. KEY RESULTS: Participants were 20.5 mean years, with 36% identifying as Latinx, 26% White, 20% Black, 10% Asian/Native Hawaiian/Pacific Islander. Scale items covered the domains of freedom from coercion, non-judgmental care, and active decision-making, and loaded on to a single factor, with a Cronbach's α of 0.80. Item responses fit a unidimensional partial credit item response model (weighted mean square statistic within 0.75-1.33 for each item), met criteria for internal structure validity, and showed no meaningful differential item functioning. Most participants expressed high agency in their contraceptive visit (mean score 9.6 out of 14). One-fifth, however, experienced low agency or coercion, with the provider wanting them to use a specific method or to make decisions for them. Agency scores were lowest among Asian/Native Hawaiian/Pacific Islander participants (adjusted coefficient: -1.5 [-2.9, -0.1] vs. White) and among those whose mothers had less than a high school education (adjusted coefficient; -2.1 [-3.3, -0.8] vs. college degree or more). CONCLUSIONS: The Contraceptive Agency Scale can be used in research and clinical care to reinforce non-coercive service provision as a standard of care.

Prenatal and postpartum care during the COVID-19 pandemic: An increase in barriers from early to mid-pandemic in the United States.

BACKGROUND: The COVID-19 pandemic led to changes in the provision of pregnancy and postpartum care. The purpose of this study was to describe changes in access to prenatal and postpartum care over time, from early in the pandemic (July 2020) to mid-pandemic (January 2021) and to explore socioeconomic and COVID-19-related economic factors associated with experiencing barriers to care. METHODS: We recruited two cross sections of women and birthing people in the US in July 2020 (N = 4645) and January 2021 (N = 3343) using Facebook and Instagram Ads. RESULTS: Three out of four women in the prenatal period and four out of five women in the postpartum period reported barriers to scheduling a visit. The likelihood of not having a visit (OR = 4.44, 95% CI 2.67-7.40), being unable to schedule a visit (OR = 2.73, 95% CI 1.71-4.35), and not being offered visits (OR = 4.26, 95% CI 2.32-7.81) increased over time. Participants were more likely to report barriers attending scheduled prenatal or postpartum appointments over time (OR = 2.72, 95% CI 2.14-3.45). Women who experienced more economic impacts from COVID-19 were older, less educated, and were Black, Indigenous, or a person of color, and were more likely to have barriers to attending appointments. CONCLUSIONS: Certain subgroups are more at risk during COVID-19, and around 9 months into the pandemic, women were not only still facing barriers to care, but these had been amplified. Additional research using other data sources is needed to identify and ameliorate barriers and inequalities in access to prenatal and postpartum care that appear to have persisted throughout the pandemic.

Informal Caregiving Among Faculty at a Large Academic Health Sciences University in the United States: an Opportunity for Policy Changes.

OBJECTIVE: This article aims to determine the prevalence of caregiving among faculty at a large academic health sciences institution, to examine the effect of gender and other demographic and professional covariates on caregiving status, and to explore caregiver-generated policy recommendations. METHOD: A cross-sectional, mixed-methods survey was collected from June through August 2018. Participants were faculty within one of the institution's health professional schools (dentistry, medicine, nursing, or pharmacy) receiving at least 50% salary from the institution. In addition to demographic information, we collected academic series and rank, and assessed association between covariates on caregiving status using logistic regression. We analyzed open-ended responses using thematic analysis to identify themes in caregiver barriers and policy suggestions. RESULTS: Among 657 eligible respondents, 11.4% were informal caregivers. Women were more likely to be caregivers than men (aOR 2.53, 95% CI: 1.40, 4.78), as were older faculty. Caregivers identified unsupportive climate or unrealistic work expectations, concern about career advancement, insufficient information about policies, and concern about colleague burden as barriers to support. Suggestions for workplace support included improved leave policies, increased flexibility, caregiver resource support, improved clarity and dissemination of policy information, and financial support. CONCLUSIONS: Women faculty are more likely to be informal caregivers, exacerbating disparities within academic medicine for promotion and retention among women faculty. Institutions might include caregiving status in annual burnout surveys to guide the development of structural support and policies for extension of family leave beyond childbearing (or catastrophic leave), flexibility in work hours, and subsidized eldercare services.

Association of Facility Type With Procedural-Related Morbidities and Adverse Events Among Patients Undergoing Induced Abortions.

Importance: Multiple states have laws requiring abortion facilities to meet ambulatory surgery center (ASC) standards. There is limited evidence regarding abortion-related morbidities and adverse events following abortions performed at ASCs vs office-based settings. Objective: To compare abortion-related morbidities and adverse events at ASCs vs office-based settings. Design, Setting, and Participants: Retrospective cohort study of women with US private health insurance who underwent induced abortions in an ASC or office-based setting (January 1, 2011-December 31, 2014). Outcomes were abstracted from a large national private insurance claims database during the 6 weeks following the abortion (date of final follow-up, February 11, 2015). Exposures: Facility type for abortion (ASCs vs office-based settings, including facilities such as abortion clinics, nonspecialized clinics, and physician offices). Main Outcomes and Measures: The primary outcome was any abortion-related morbidity or adverse event (such as retained products of conception, abortion-related infection, hemorrhage, and uterine perforation) within 6 weeks after an abortion. Two secondary outcomes, both subsets of the primary outcome, were major abortion-related morbidities and adverse events (such as hemorrhages treated with a transfusion, missed ectopic pregnancies treated with surgery, and abortion-related infections that resulted in an overnight hospital admission) and abortion-related infections. Results: Among 49 287 women (mean age, 28 years [SD, 7.3]) who had 50 311 induced abortions, (23 891 [47%] first-trimester aspiration, 13 480 [27%] first-trimester medication, and 12 940 [26%] second trimester or later), 5660 abortions (11%) were performed in ASCs and 44 651 (89%) in office-based settings. Overall, 3.33% had an abortion-related morbidity or adverse event; 0.32% had a major abortion-related morbidity or adverse event; and 0.74% had an abortion-related infection. In adjusted analyses, there was no statistically significant difference between ASCs vs office-based settings, respectively, in the rates of abortion-related morbidities or adverse events (3.25% vs 3.33%, difference, -0.08%; [corrected] 95% CI, -0.58% to 0.43%; adjusted OR, 0.97; 95% CI, 0.81-1.17), major morbidities or adverse events (0.26% vs 0.33%; difference, -0.06%; 95% CI, -0.18% to 0.06%; adjusted OR, 0.78; 95% CI, 0.45-1.37), or infections (0.58% vs 0.77%; difference, -0.16%; 95% CI, -0.35% to 0.03%; adjusted OR, 0.75; 95% CI, 0.52-1.09). Conclusions and Relevance: Among women with private health insurance who had an induced abortion, performance of the abortion in an ambulatory surgical center compared with an office-based setting was not associated with a significant difference in abortion-related morbidities and adverse events. These findings, in addition to individual patient and individual facility factors, may inform decisions about the type of facility in which induced abortions are performed.

Dilation and evacuation training in maternal-fetal medicine fellowships.

OBJECTIVE: Many maternal-fetal medicine (MFM) specialists provide dilation and evacuation (D&E) procedures for their patients with fetal or obstetric complications. Our study describes the D&E training opportunities that are available to MFM trainees during their fellowship. STUDY DESIGN: National surveys of MFM fellows and fellowship program directors assessed the availability of D&E training in fellowship. Univariate and multivariate comparisons of correlates of D&E training and provision were performed. RESULTS: Of the 270 MFM fellows and 79 fellowship directors who were contacted, 92 (34%) and 44 (56%) responded, respectively. More than one-half of fellows (60/92) and almost one-half of fellowship programs (20/44) report organized training opportunities for D&E. Three-quarters of fellows who were surveyed believe that D&E training should be part of MFM fellowship, and one-third of fellows who have not yet been trained would like training opportunities. Being at a fellowship that offers D&E training is associated with 7.5 times higher odds of intending to provide D&E after graduation (P = .005; 95% confidence interval, 1.8-30). CONCLUSION: MFM physicians are in a unique position to provide termination services for their patients with pregnancy complications. Many MFM subspecialists provide D&E services during fellowship and plan to continue after graduation. MFM fellows express a strong interest in D&E training; therefore, D&E training opportunities should be offered as a part of MFM fellowship.

Society of Family Planning Clinical Recommendation: Management of hemorrhage at the time of abortion.

Hemorrhage after abortion is rare, occurring in fewer than 1% of abortions, but associated morbidity may be significant. Although medication abortion is associated with more bleeding than procedural abortion, overall bleeding for the two methods is minimal and not clinically different. Hemorrhage can be caused by atony, coagulopathy, and abnormal placentation, as well as by such procedure complications as perforation, cervical laceration, and retained tissue. Evidence for practices around postabortion hemorrhage is extremely limited. The Society of Family Planning recommends preoperative identification of individuals at high risk of hemorrhage as well as development of an organized approach to treatment. Specifically, individuals with a uterine scar and complete placenta previa seeking abortion at gestations after the first trimester should be evaluated for placenta accreta spectrum. For those at high risk of hemorrhage, referral to a higher-acuity center should be considered. We propose an algorithm for treating postabortion hemorrhage as follows: (1) assessment and examination, (2) uterine massage and medical therapy, (3) resuscitative measures with laboratory evaluation and possible reaspiration or balloon tamponade, and (4) interventions such as embolization and surgery. Evidence supports the use of oxytocin as prophylaxis for bleeding with dilation and evacuation; methylergonovine prophylaxis, however, is associated with more bleeding at the time of dilation and evacuation. Future research is needed on tranexamic acid as prophylaxis and treatment and misoprostol as prophylaxis. Structural inequities contribute to bleeding risk. Acknowledging how our policies hinder or remedy health inequities is essential when developing new guidelines and approaches to clinical services.

Contraceptive care in the United States during the COVID-19 pandemic: A social media survey of contraceptive access, telehealth use and telehealth quality.

OBJECTIVES: To examine demographic, socioeconomic, and regional differences in contraceptive access, differences between telehealth and in-person contraception visits, and telehealth quality in the United States during the COVID-19 pandemic. STUDY DESIGN: We surveyed reproductive-age women about contraception visits during the COVID-19 pandemic via social media in July 2020 and January 2021. We used multivariable regression to examine relationships between age, racial/ethnic identity, educational attainment, income, insurance type, region, and COVID-19 related hardship, and ability to obtain a contraceptive appointment, telehealth vs in-person visits, and telehealth quality scores. RESULTS: Among 2031 respondents seeking a contraception visit, 1490 (73.4%) reported any visit, of which 530 (35.6%) were telehealth. In adjusted analyses, lower odds of any visit was associated with Hispanic/Latinx and Mixed race/Other identity (aOR 0.59 [0.37-0.94], aOR 0.36 [0.22-0.59], respectively), the South, Midwest, Northeast (aOR 0.63 [0.47-0.85], aOR 0.64 [0.46-0.90], aOR 0.52 [CI 0.36-0.75], respectively), no insurance (aOR 0.63 [0.43-0.91]), greater COVID-19 hardship (aOR 0.52 [0.31-0.87]), and earlier pandemic timing (January 2021 vs July 2020 aOR 2.14 [1.69-2.70]). Respondents from the Midwest and South had lower odds of telehealth vs in-person care (aOR 0.63 [0.44-0.88], aOR 0.54 [0.40-0.72], respectively). Hispanic/Latinx respondents and those in the Midwest had lower odds of high telehealth quality (aOR 0.37 [0.17-0.80], aOR 0.58 [0.35-0.95], respectively). CONCLUSIONS: We found inequities in contraceptive care access, less telehealth use for contraception visits in the South and Midwest, and lower telehealth quality among Hispanic/Latinx people during the COVID-19 pandemic. Future research should focus on telehealth access, quality, and patients' preferences. IMPLICATIONS: Historically marginalized groups have faced disproportionate barriers to contraceptive care, and telehealth for contraceptive care has not been employed equitably during the COVID-19 pandemic. Though telehealth has the potential to improve access to care, inequitable implementation could exacerbate existing disparities.

Levonorgestrel 52-mg Intrauterine Device Efficacy and Safety After More Than 8 Years of Use.

FUNDING SOURCE: Medicines360. The Sponsor, Medicines360, designed the study and oversaw its conduct, including funding the trial and providing all study product free of charge to participants. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT00995150.

Maternal-fetal medicine subspecialists' provision of second-trimester termination services.

OBJECTIVE: Most abortions for pregnancy complications occur in the second trimester. Little is known about whether maternal-fetal medicine subspecialists (MFMs) perform terminations for these women. STUDY DESIGN: We surveyed all members of Society of Maternal Fetal Medicine by e-mail or mail regarding second-trimester abortion provision. We conducted analyses of whether MFMs perform abortions, by what method, and how frequently. RESULTS: Our response rate was 32.4% (689/2,125). Over two-thirds of respondents perform either dilation and evacuation (D&E) or induction; 31% perform D&Es. Male gender, frequent chorionic villus sampling provision, and being trained in D&E during fellowship are associated with performing D&Es. Nonprovision of any second-trimester abortion is significantly associated with age over 50, nonacademic practice setting, and less supportive abortion attitudes (p < 0.001). A nonsignificant trend toward association between south/southeast region and nonprovision of any second-trimester abortion is seen (p = 0.09). CONCLUSION: Many MFMs include D&E and induction termination services in their practice. Supporting current D&E providers and expanding training options for MFMs may optimize care for women diagnosed with serious pregnancy complications.

Traveling to California from out of state to receive abortion services at a hospital-based clinic: A qualitative study of people's experiences.

OBJECTIVE: People seeking abortion care in the Western United States face unique challenges. We conducted a qualitative study among people who traveled to California from out of state to receive abortion services, with the aim of characterizing the interplay of motivators, costs, and facilitators to accessing abortion in this region. METHODS: We recruited English-speaking people residing outside of California who accessed care at an urban abortion clinic in San Francisco between October 2017 and May 2018. Interested participants completed a brief demographic survey and in depth semi-structured telephone interview. We relied on grounded theory methods to perform thematic analysis and stopped recruitment upon reaching thematic saturation. RESULTS: We conducted 18 in-depth interviews. People mostly had to travel to California for abortion due to local clinic gestational age limits, medical necessity, and to reduce cost. Participants also lamented that travel necessitated unwanted disclosure of their abortion, however this disclosure enabled them to get the logistical support needed for travel. People mostly relied on their networks of family and friends to facilitate these logistics. CONCLUSIONS: This study highlights the interplay of motivators, costs, and facilitators people who travel to California from nearby states face when seeking abortion services. IMPLICATIONS: We position the concept of 'unwanted disclosure' as both an emotional cost and an operator that often served to enable people to get the support (logistical, financial, professional) they needed to actualize their abortion in California. These people may benefit from additional financial and social support services in order to actualize their abortion.

Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial.

Background: The most widely used copper intrauterine device (IUD) in the world (the TCu380A), and the only product available in many countries, causes side effects and early removals for many users. These problems are exacerbated in nulliparous women, who have smaller uterine cavities compared to parous women. We compared first-year continuation rates and reasons/probabilities for early removal of the TCu380A versus a smaller Belgian copper IUD among nulliparous users. Methods: This 12-month interim report is derived from a pre-planned interim analysis of a sub population and focused on key secondary comparative endpoints. In this participant-blinded trial at 16 centres in the USA, we randomised participants aged 17-40 in a 4:1 ratio to the NT380-Mini or the TCu380A. In the first year, participants had follow-up visits at 6-weeks and 3, 6, and 12-months, and a phone contact at 9 months; we documented continued use, expulsions, and reasons for removal. Among participants with successful IUD placement, we compared probabilities of IUD continuation and specific reasons for discontinuation using log-rank tests. This trial is registered with ClinicalTrials.gov number NCT03124160 and is closed to recruitment. Findings: Between June 1, 2017, and February 25, 2019, we assigned 927 nulliparous women to either the NT380-Mini (n = 744) or the TCu380A (n = 183); the analysis population was 732 (NT380-Mini) and 176 (TCu380A). Participants using the NT380-Mini, compared to the TCu380A, had higher 12-month continuation rates (78·7% [95% CI: 72·9-84·5%] vs. 70·2% [95% CI: 59·7-80·7], p = 0·014), lower rates of removal for bleeding and/or pain (8·1% vs. 16·2%, p = 0·003) and lower IUD expulsion rates (4·8% vs. 8·9%, p = 0·023), respectively. Interpretation: The NT380-Mini offers important benefits for a nulliparous population compared to the TCu380A in the first twelve months, when pivotal experiences typically occur. Higher continuation rates with the NT380-Mini may avert disruptions in contraceptive use and help users avoid unintended pregnancy. Funding: Bill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Mona Lisa, N.V. (Belgium).

Implementation of expedited partner therapy among women with chlamydia infection at an urban family planning clinic.

BACKGROUND: Reinfection with chlamydia is common and expedited partner therapy (EPT) decreases reinfection in clinical trials. Many clinical practices have adopted EPT as the principal treatment strategy for male partners. Little is known about its application and effectiveness in a community setting. METHODS: We conducted a retrospective cohort study of all female patients with chlamydia between 2004 and 2005 at a university-based family planning clinic. We abstracted demographic and clinical information from charts, including partner treatment strategy. We collected data on reinfection at 3 months and 1 year using a computerized database of laboratory results within the medical system. RESULTS: During 2004 to 2005, 499 women tested positive for chlamydia. Of the 466 women treated, EPT was given to 323 women (69.3%). No baseline characteristics were associated with EPT provision. Only 40% of women returned for a retest within 3 months. Reinfection at 3 months was 4.8%. Patients who received EPT were as likely to be reinfected than those who did not receive EPT (odds ratio, 1.6; 95% confidence interval, 0.2-13.7). CONCLUSIONS: Although EPT was not associated with decreased reinfection, it remains an option for partner treatment. This study highlights the ongoing need to address compliance with retesting within 3 months.

A randomized controlled trial of methylergonovine prophylaxis after dilation and evacuation abortion.

OBJECTIVE: To evaluate the efficacy of intramuscular methylergonovine maleate as prophylaxis against excessive bleeding when given after dilation and evacuation (D&E) at 20-24 weeks. STUDY DESIGN: We performed a randomized, double-blinded, placebo-controlled trial in patients without excessive bleeding requiring intervention after D&E completion. We administered study treatment within one minute of the end of the procedure. We primarily compared outcomes using a composite of indicators of excessive post-procedure blood loss (post-procedure measured blood loss exceeding 125 mL, uterine massage or compression for at least two minutes, administration of additional uterotonic medication, intrauterine balloon tamponade, uterine re-aspiration, blood transfusion, uterine artery embolization, hospital admission for bleeding, or major surgery). Secondary outcomes included individual indicator occurrences, satisfaction, and side effects. RESULTS: From March 3, 2015 to March 31, 2017, we randomized 284 participants (n = 140 methylergonovine, n = 144 placebo), five before we registered the trial with clinicaltrials.gov. Baseline characteristics were similar between groups. The composite outcome occurred in 78 (56%) methylergonovine and 75 (52%) placebo participants (p = 0.5). Methylergonovine recipients required more intrauterine balloon use (n = 20 [14%]) versus placebo (n = 10 [7%]), p = 0.04. We also observed a non-significant trend towards more uterotonic administration (n = 56 [40%] versus n = 43 [30%], p = 0.07) and hospital admissions for bleeding (n = 4 [3%] versus n = 0, p = 0.06) in the methylergonovine group compared to placebo. CONCLUSION: We observed no improvement in the composite outcome for excessive bleeding with prophylactic post-procedure methylergonovine. In addition, individual excessive bleeding outcomes occurred more frequently in the methylergonovine group, potentially indicating harm with its prophylactic use after D&E. IMPLICATIONS: When administered prophylactically immediately after dilation and evacuation abortion at 20-24 weeks, methylergonovine increases uterine bleeding. Given the lack of data for effectiveness as a prophylactic agent and our findings indicating harm, we do not recommend its use for post-operative prophylaxis.

Miscarriage Treatment-Related Morbidities and Adverse Events in Hospitals, Ambulatory Surgery Centers, and Office-Based Settings.

OBJECTIVE: The aim of the study was to examine whether miscarriage treatment-related morbidities and adverse events vary across facility types. METHODS: A retrospective cohort study compared miscarriage treatment-related morbidities and adverse events across hospitals, ambulatory surgery centers (ASCs), and office-based settings. Data on women who had miscarriage treatment between 2011 and 2014 and were continuously enrolled in their insurance plan for at least 1 year before and at least 6 weeks after treatment were obtained from a large national private insurance claims database. The main outcome was miscarriage treatment-related morbidities and adverse events occurring within 6 weeks of miscarriage treatment. Secondary outcomes were major events and infections. RESULTS: A total of 97,374 miscarriage treatments met inclusion criteria. Most (75%) were provided in hospitals, 10% ASCs, and 15% office-based settings. A total of 9.3% had miscarriage treatment-related events, 1.0% major events, and 1.5% infections. In adjusted analyses, there were fewer events in ASCs (6.5%) than office-based settings (9.4%) and hospitals (9.6%), but no significant difference between office-based settings and hospitals. There were no significant differences in major events between ASCs (0.7%) and office-based settings (0.8%), but more in hospitals (1.1%) than ASCs and office-based settings. There were fewer infections in ASCs (0.9%) than office-based settings (1.2%) and more in hospitals (1.6%) than ASCs and office-based settings. In analyses stratified by miscarriage treatment type, the difference between ASCs and office-based settings was no longer significant for miscarriages treated with procedures. CONCLUSIONS: Although there seem to be slightly more events in hospitals than ASCs or office-based settings, findings do not support limiting miscarriage treatment to particular settings.

Disseminated Intravascular Coagulation and Hemorrhage After Dilation and Evacuation Abortion for Fetal Death.

OBJECTIVE: To examine the association between fetal death and risk of hemorrhage and disseminated intravascular coagulation (DIC) among women undergoing dilation and evacuation (D&E) procedures. METHODS: We conducted a retrospective cohort study of all D&Es at one academic abortion clinic in San Francisco between 2009 and 2013. We abstracted data on fetal death status, demographic characteristics, and complications including hemorrhage and DIC. We examined the risk of hemorrhage and DIC among women with fetal death compared with those without. We conducted unadjusted and adjusted analyses for the outcomes of hemorrhage, DIC, and any complication. RESULTS: Among 92 cases of D&E for fetal death and 4,428 cases of D&E for other reasons, hemorrhage occurred in 10% and 7%, respectively (P=.28), and DIC occurred in 2.0% and 0.2% of the fetal death and nonfetal death cohorts (P<.001). In adjusted analysis, fetal death was associated with 2.9 times higher odds of hemorrhage (95% CI 1.4-6.0). In an unadjusted analysis, fetal death was associated with 12.3 times higher odds of DIC (95% CI 2.6-58.6) and 3.0 times higher odds of any complication (95% CI 1.6-5.9). CONCLUSION: Women undergoing D&E for fetal death are far more likely to experience DIC and hemorrhage than are women without fetal death, yet the absolute risk is low (2%). Although D&E providers should be prepared for DIC and hemorrhage, we do not recommend any specific preoperative preparation because the vast majority of D&E abortions for fetal death are uncomplicated.

How does Fetal Autopsy after Pregnancy Loss or Termination for Anomalies and other Complications Change Recurrence Risk?

Objective Historically, fetal autopsy was common after terminations for anomalies. Previous studies report that fetal autopsy confirms ultrasound findings in the majority of cases. This study aims to examine correlation between prenatal and autopsy diagnoses at University of California, San Francisco (UCSF) and evaluate whether autopsy adds diagnostic information, specifically information that changes risk of recurrence for future pregnancies. Study Design We conducted a retrospective chart review of all fetal autopsies performed at UCSF between 1994 and 2009. Prenatal diagnosis was compared with autopsy diagnosis; for cases where there was a change in diagnosis, an MFM (maternal-fetal medicine specialist) reviewed the case to assign risk of recurrence before and after autopsy. Results Overall, there was concordance between prenatal diagnosis and autopsy diagnosis in greater than 91.7% of cases. Autopsy added information that resulted in a change in recurrence risk in 2.3% of cases ( n = 9). Conclusion For the vast majority of cases, there is agreement between prenatal and autopsy diagnosis after pregnancy loss or termination for fetal anomalies. Only a small percentage of autopsies change recurrence risk. This may be useful when counseling women about method of termination and when counseling couples about whether to have an autopsy.

Effects of Legislation Regulating Abortion in Arizona.

INTRODUCTION: Abortion is a common and safe procedure in the United States, the regulation of which varies by state. Since 2011, hundreds of state-level abortion restrictions have been enacted by legislatures across the country. This study describes the effects of two such regulations enacted in 2011 in Arizona, (A.R.S.) 36-2153 and 36-2155, that imposed a 24-hour waiting period requiring two separate in-person clinic visits before obtaining an abortion and banned advanced practice clinicians such as physician assistants, nurse practitioners, and nurse midwives from inducing medication abortions by prescribing mifepristone. MATERIALS AND METHODS: We conducted a pre-post study to describe the effect of Arizona's scope of practice law on abortion provision by county. Using publicly available data, we compared patterns of abortion provision in 2009 and 2010 (before the laws) with 2012 and 2013. Our primary objective was to compare the proportion of abortions performed with medication by prescription of mifepristone (versus abortions performed surgically, known as aspiration abortions) before and after the laws were enacted. Our secondary objectives were to report the number of counties that lost an abortion provider and the change in the proportion of abortions performed before 14 weeks' gestation of pregnancy after the enactment of the laws. RESULTS: After enactment of the laws, the proportion of Arizona's 15 counties with abortion clinics decreased from 33% to 13%. Over this time, the proportion of abortions performed with medication in Arizona decreased by 17.4% (95% CI, 16.6%-18.3%; p = .0002), from 47.6% to 30.2%. Similarly, the proportion of abortions performed before 14 weeks' gestation in Arizona decreased by 3.3% (95% CI, 2.8%-3.8%; p = .0002) after the enactment of these laws. DISCUSSION: The proportion of abortions performed with medication and the proportion of abortion performed before 14 weeks' gestation in Arizona were negatively affected by the enactment of these laws. These findings are not explained by national temporal trends in abortion, because the proportion of abortions performed with medication increased and early abortions remained stable over the same time period in the United States as a whole. CONCLUSIONS: Proponents of laws restricting the provision of abortion such as these claim to improve the safety of abortion, but they actually seem to decrease access to abortion, as defined by the number of counties with abortion providers, and subsequently lead to delays in abortion. These data should inform future policies by providing an example of how such laws affect women seeking abortion.

Decision satisfaction among women choosing a method of pregnancy termination in the setting of fetal anomalies and other pregnancy complications: A qualitative study.

OBJECTIVE: The decision to undergo a surgical or medical method of second-trimester termination for pregnancy complications should be preference-sensitive. Decision satisfaction has not been described in this population; understanding how women describe decision satisfaction in this setting could inform decision support efforts. METHODS: We conducted qualitative interviews with women one to three weeks after termination who chose either a surgical or medical termination for fetal anomalies, pregnancy complications or fetal demise. We analyzed transcripts using modified grounded theory in an iterative manner with a generative thematic approach. RESULTS: We interviewed 36 women (24 surgical and 12 medical). Subjects connected decision satisfaction with counseling experiences and their personal values, including (1) importance of adequate information, (2) autonomous decision making, and (3) choosing the method that facilitates coping. CONCLUSION: Offering women a choice between surgical and medical termination procedures in the setting of pregnancy complications is integral to decision satisfaction. Women in our study reported wanting this decision to be driven by their personal values. PRACTICE IMPLICATIONS: Women should be able to choose between surgical and medical termination based on preference and not availability of services. Decision support from women's health providers should be based on values clarification and providing accurate information.