Placenta accreta spectrum in the second trimester: a clinical conundrum in procedural abortion care.

Given the limitations in perioperative management strategies available at freestanding abortion clinics, abortion providers must commonly discern which patients are too complicated for procedural abortions at their center and must be referred for a hospital-based abortion. The need to transition from freestanding clinics to hospital-based abortion care can lead to delays in completing an abortion and significant social, economic, and psychological repercussions for the pregnant individual. One significant clinical problem that exemplifies the issue of who can be safely taken care of at a freestanding abortion clinic is when placenta accreta spectrum is suspected. Placenta accreta spectrum is one of the major contributors to maternal morbidity and mortality in the United States, requiring coordinated multidisciplinary management to ensure the safest outcome for the pregnant individual. In this Clinical Opinion, we review the literature focused on identifying individuals at risk for placenta accreta spectrum above 14 0/7 weeks gestation, delineate an algorithm to improve the frequency of timely referrals to hospital-based abortion providers, and propose next steps for future training goals and research on placenta accreta spectrum in the second trimester between complex family planning and maternal-fetal medicine subspecialists.

A National Database Study on Racial Disparities in Route of Hysterectomy with a Surrogate Control for Uterine Size: A Proposed Quality Metric for Benign Indications.

STUDY OBJECTIVE: To investigate the association between race and route of hysterectomy among patients undergoing hysterectomy for abnormal uterine bleeding in the absence of uterine fibroid disease and excluding malignancy. DESIGN: A cross-sectional cohort study utilizing the Healthcare Cost and Utilization Project Nationwide Inpatient Sample and National Ambulatory Surgical databases to compare abdominal to minimally invasive route of hysterectomy. SETTING: Hospitals and hospital-affiliated ambulatory surgical centers participating in the Healthcare Cost and Utilization Project in 2019 PATIENTS: 75,838 patients who had undergone hysterectomy for abnormal uterine bleeding excluding uterine fibroids and malignancy. INTERVENTIONS: n/a MEASUREMENTS AND MAIN RESULTS: Of the 75,838 hysterectomies performed for abnormal uterine bleeding in the absence of uterine fibroids and malignancy, 10.1% were performed abdominally and 89.9% minimally invasively. After adjusting for confounders, Black patients were 38% more likely to undergo abdominal hysterectomy compared to White patients (OR 1.38, CI 1.12-1.70 p=0.002). Black race thus is independently associated with open surgery. CONCLUSION: Despite excluding uterine fibroids as a risk factor for an abdominal route of hysterectomy, Black race remained an independent predictor for abdominal versus minimally invasive hysterectomy and Black patients were found to undergo a disproportionately higher rate of abdominal hysterectomy compared to White patients.

Obstacles to Accepting Care: Understanding Why Obstetric Patients Leave against Medical Advice.

INTRODUCTION: Discharge "against medical advice" (AMA) in the obstetric population is overall under-studied but disproportionally affects marginalized populations and is associated with worse perinatal outcomes. Reasons for discharges AMA are not well understood. The objective of this study is to identify the obstacles that prevent obstetric patients from accepting recommended care and highlight the structural reasons behind AMA discharges. METHODS: Electronic health records of patients admitted to antepartum, peripartum, or postpartum services between 2008 and 2018 who left "AMA" were reviewed. Progress notes from clinicians and social workers were extracted and analyzed. Reasons behind discharge were categorized using qualitative thematic analysis. RESULTS: Fifty-seven (0.12%) obstetric patients were discharged AMA. Reasons for discharge were organized into two overarching themes: extrinsic (50.9%) and intrinsic (40.4%) obstacles to accepting care. Eleven participants (19.3%) had no reason documented for their discharge. Extrinsic obstacles included childcare, familial responsibilities, and other obligations. Intrinsic obstacles included disagreement with provider regarding medical condition or plan, emotional distress, mistrust or discontent with care team, and substance use. DISCUSSION: The term "AMA" casts blame on individual patients and fails to represent the systemic barriers to staying in care. Obstetric patients were found to encounter both extrinsic and intrinsic obstacles that led them to leave AMA. Healthcare providers and institutions can implement strategies that ameliorate structural barriers. Partnering with patients to prevent discharges AMA would improve maternal and infant health and progress towards reproductive justice.

Neighborhood deprivation is not associated with abortion consideration or completion in patients with fetal myelomeningocele.

OBJECTIVE: The objective of this study was to evaluate whether patient-level neighborhood deprivation index (NDI) was associated with termination of pregnancy consideration and completion in patients presenting with fetal myelomeningocele. METHODS: This was a retrospective cohort analysis of patients with fetal myelomeningocele presenting to a fetal treatment center (FTC) in Illinois between 2018 and 2024. The exposure was NDI calculated from patient zip codes. The NDI was analyzed as both a dichotomous and ordinal exposure. The co-primary outcomes were abortion consideration prior to FTC consultation, ascertained by nurse intake, and abortion completion after consultation. Bivariate and log-binomial regression analyses were performed. Covariates were selected based on p < 0.10 on bivariate analyses. Otherwise, p < 0.05 indicated statistical significance. RESULTS: A total of 157 participants were included. Evaluation of neighborhood deprivation as a dichotomous exposure revealed no association with abortion consideration or completion. AdditionallLy, no association was found on log binomial modeling after controlling for gestational age at presentation to the FTC and maternal race or ethnicity for abortion consideration (aRR 0.87, 95% CI 0.59-1.28) or completion (aRR 0.86, 95% CI 0.59-1.28). These results were similar when treating the NDI as an ordinal exposure. CONCLUSIONS: Contrary to our hypothesis, NDI is not associated with abortion consideration or completion in patients with fetal myelomeningocele.

Duration of Induction of Labor for Second-Trimester Medication Abortion and Adverse Outcomes.

OBJECTIVE: To evaluate the relationship between duration of labor during second-trimester medication abortion and adverse outcomes. METHODS: We conducted a retrospective cohort study including all individuals with a singleton gestation undergoing second-trimester medication abortion without evidence of advanced cervical dilation, rupture of membranes, or preterm labor at four centers. The primary exposure was duration of labor (ie, hours spent from receiving misoprostol to fetal expulsion). The primary outcome was composite morbidity , defined as uterine rupture, need for blood transfusion, clinical chorioamnionitis, intensive care unit admission, or need for readmission. We performed bivariate and multivariate negative binomial analyses. A post hoc subgroup analysis was performed to assess for the risk of the primary outcome by gestational age. We performed tests of homogeneity based on history of uterine scarring and parity. RESULTS: Six hundred eighty-one individuals were included. The median duration of labor was 11 hours (interquartile range 8-17 hours). One hundred thirty-one (19.2%) experienced the primary outcome. When duration of labor was evaluated continuously, a longer duration of labor was associated with an increased frequency of morbidity (adjusted ß=0.68, 95% CI, 0.32-1.04). When duration of labor was evaluated categorically, those experiencing the highest quartile of duration (ie, 17 hours or more) had a statistically higher risk for experiencing morbidity compared with individuals in all other quartiles (adjusted relative risk 1.99, 95% CI, 1.34-2.96). When we focused on components of the composite outcome, clinical chorioamnionitis was significantly different between those experiencing a longer duration and those experiencing a shorter duration of labor (26.2% vs 10.6%, P <.001). On subgroup analysis, gestational age was not associated with the risk of composite morbidity. Tests of homogeneity demonstrated no significant difference in the risk for morbidity among individuals with a history of uterine scarring or based on parity. CONCLUSION: Duration of labor was independently associated with risks for adverse maternal outcomes during second-trimester medication abortion, specifically clinical chorioamnionitis.

Real-world evidence for the utility of serum soluble fms-like tyrosine kinase 1/placental growth factor test for routine clinical evaluation of hospitalized women with hypertensive disorders of pregnancy.

BACKGROUND: An imbalance of the antiangiogenic factor, soluble fms-like tyrosine kinase-1, and proangiogenic factor, placental growth factor, in the circulation is a reliable predictor for the development of preeclampsia with severe features and related adverse outcomes. In 2023, the US Food and Drug Administration approved a serum soluble fms-like tyrosine kinase-1/placental growth factor test at a cutoff of 40 to aid in the risk assessment of women hospitalized for hypertensive disorders of pregnancy for the progression to preeclampsia with severe features between 23 and 35 weeks. OBJECTIVE: This study aimed to generate real-world evidence for clinical utility for serum soluble fms-like tyrosine kinase-1/placental growth factor test when made available to clinicians in a timely fashion as an aid in risk stratification of development of preeclampsia with severe features within 2 weeks of testing among hospitalized patients with hypertensive disorders of pregnancy. STUDY DESIGN: Hospitalized patients with hypertensive disorders of pregnancy between 23 weeks to 34 weeks and 6 days of gestation were prospectively studied from June 2023 to January 2024 after the implementation of serum soluble fms-like tyrosine kinase-1/placental growth factor testing into routine clinical practice. Serum samples were obtained from patients via venipuncture and analyzed on an automated immunoassay platform (placental growth factor and soluble fms-like tyrosine kinase-1 assays; Thermo Fisher Scientific). Before implementation, physicians were educated on appropriate use and management guidelines on the basis of biomarkers but made pragmatic management decisions independently. Results of soluble fms-like tyrosine kinase-1/placental growth factor tests were available to clinicians within 24 hours of venipuncture. The association between soluble fms-like tyrosine kinase-1/placental growth factor ≥40 and progression to preeclampsia with severe features and adverse maternal/perinatal outcomes were assessed. RESULTS: Of the 65 patient encounters, 36 had a soluble fms-like tyrosine kinase-1/placental growth factor <40 (55.4%). The rate of delivery for indications related to hypertensive disorders of pregnancy within 2 weeks was significantly lower among encounters with a low ratio vs high ratio (2/36 [5.6%] vs 21/29 [72.4%]) even after controlling for relevant confounders (adjusted hazard ratio, 7.52; 95% confidence interval, 3.05-18.54; P<.001). A diagnosis of preeclampsia with severe features within 2 weeks of testing was also less likely among the encounters with soluble fms-like tyrosine kinase-1/placental growth factor ratio <40 when compared with soluble fms-like tyrosine kinase-1/placental growth factor ratio ≥40 (2/36 [5.6%] vs 23/29 [79.3%], P<.001; positive predictive value of 79% [95% confidence interval, 0.65-0.94] and negative predictive value of 0.94 [95% confidence interval, 0.87-1.00]). The positive and negative likelihood ratios for the development of preeclampsia with severe features within 2 weeks of testing were 6.13 and 0.09, respectively. Encounters with a soluble fms-like tyrosine kinase-1/placental growth factor ratio <40 were less likely to experience a maternal or fetal adverse event as compared with encounters with soluble fms-like tyrosine kinase-1/placental growth factor ratio ≥40 (3/36 [8.3%] vs 10/29 [34.5%], P=.01). Among 36 encounters involving low soluble fms-like tyrosine kinase-1/placental growth factor values, 22 had had equivocal clinical or laboratory criteria resembling preeclampsia at presentation but were expectantly managed on the basis of biomarkers, and none developed preeclampsia with severe features or adverse outcomes at 2 weeks. The median latency defined as days between biomarker measurement and delivery in patients with a low biomarker ratio was 33 (interquartile ratio, 23-47) vs 7 (interquartile ratio, 4-14) days among patients with a high ratio (P<.001). Corticosteroid use within 2 weeks was also significantly reduced in the low biomarker group when compared with the high biomarker group (8/35 [22.9%] vs 24/29 [82.8%], P<.001). CONCLUSION: In this study, the incorporation of soluble fms-like tyrosine kinase-1/placental growth factor ratio into clinical practice serves as a dependable supplement in assessing risk for progression to preeclampsia with severe features and adverse outcomes in patients with hypertensive disorders of pregnancy in the United States. Among patients with a low ratio, pregnancy may be prolonged, which results in better neonatal outcomes without harm to the mother.

Extended postpartum outcomes with systematic treatment of and management of postpartum hypertension program.

OBJECTIVE: The purpose of this study was to examine the long-term effect of a quality improvement initiative at one-year post delivery. STUDY DESIGN: This was a retrospective study of 1480 patients who delivered between October 2018 and June 2020 at the study institution and were enrolled in the Systematic Treatment and Management of PostPartum Hypertension Program (STAMPP). Patients received standardized cuffs, education, and follow-up. At the six-week postpartum follow-up, patients were again given instructions to establish follow-up. MAIN OUTCOME MEASURES: The primary outcome was a visit with a primary care physician (PCP) or cardiologist between 6 weeks and 1 year postpartum. RESULTS: A total of 939 (63 %) patients had some follow-up within twelve months. Of these, 113 (12 %) and 175 (19 %) had follow-up with cardiology and primary care providers, respectively. Patients with no follow-up were more likely to have public aid (73.9 % vs 60.3 %; p < 0.001). 77 % identified as Black, with only 12 % of this cohort following up with cardiology and 13 % with a PCP. CONCLUSIONS: Despite specific counseling about long term follow-up, a minority of patients completed one year follow-up, notably amongst Black patients and those with public insurance. Further work is needed to optimize long-term follow-up after HDP to reduce the prevalence of cardiovascular disease, especially amongst high-risk patients.

Peripartum interventions for people with class III obesity: a systematic review and meta-analysis.

OBJECTIVE: This study aimed to identify evidence-based peripartum interventions for people with a body mass index ≥40 kg/m2. DATA SOURCES: PubMed, MEDLINE, EMBASE, Cochrane, CINAHL, and ClinicalTrials.gov were searched from inception to 2022 without date, publication type, or language restrictions. STUDY ELIGIBILITY CRITERIA: Cohort and randomized controlled trials that implemented an intervention and evaluated peripartum outcomes of people with a body mass index ≥40 kg/m2 were included. The primary outcome depended on the intervention but was commonly related to wound morbidity after cesarean delivery (ie, infection, separation, hematoma). METHODS: Meta-analysis was completed for interventions with at least 2 studies. Pooled risk ratios with 95% confidence intervals and heterogeneity (I2 statistics) were reported. RESULTS: Of 20,301 studies screened, 30 studies (17 cohort and 13 randomized controlled trials) encompassing 10 types of interventions were included. The interventions included delivery planning (induction of labor, planned cesarean delivery), antibiotics during labor induction or for surgical prophylaxis, 6 types of cesarean delivery techniques, and anticoagulation dosing after a cesarean delivery. Planned cesarean delivery compared with planned vaginal delivery did not improve outcomes according to 3 cohort studies. One cohort study compared 3 g with 2 g of cephazolin prophylaxis for cesarean delivery and found no differences in surgical site infections. According to 3 cohort studies and 2 randomized controlled trials, there was no improvement in outcomes with a non-low transverse skin incision. Ten studies (4 cohort and 6 randomized controlled trials) met the inclusion criteria for the meta-analysis. Two randomized controlled trials compared subcuticular closure with suture vs staples after cesarean delivery and found no differences in wound morbidity within 6 weeks of cesarean delivery (n=422; risk ratio, 1.09; 95% confidence interval, 0.75-1.59; I2=9%). Prophylactic negative-pressure wound therapy was compared with standard dressing in 4 cohort and 4 randomized controlled trials, which found no differences in wound morbidity (cohort n=2200; risk ratio, 1.19; 95% confidence interval, 0.88-1.63; I2=66.1%) or surgical site infections (randomized controlled trial n=1262; risk ratio, 0.90; 95% confidence interval, 0.63-1.29; I2=0). CONCLUSION: Few studies address interventions in people with a body mass index ≥40 kg/m2, and most studies did not demonstrate a benefit. Either staples or suture are recommended for subcuticular closure, but available data do not support prophylactic negative-pressure wound therapy after cesarean delivery for people with a body mass index ≥40 kg/m2.

Intimate Partner Violence Detected during Abortion-Related Visits: A Systematic Review of Screenings and Interventions.

OBJECTIVE: To perform a systematic review of screening tools and interventions focused on reducing adverse health outcomes associated with intimate partner violence (IPV) at abortion-related visits. STUDY DESIGN: Studies were eligible if they included individuals seeking pregnancy options health care services in the United States, screening for or implementation of an intervention for IPV, and were published in English after the year 2000. The primary outcomes were to summarize screening tools, interventions studied, and if interventions led to individuals being connected to IPV-related resources. Secondary outcomes included patient responses to the IPV-related interventions and any other outcomes reported by the studies (PROSPERO #42021252199). RESULTS: Among 4,205 abstracts identified, nine studies met inclusion criteria. The majority (n = 6) employed the ARCHES (Addressing Reproductive Coercion in Health Settings) tool for identification of IPV. Interventions included provider-facilitated discussions of IPV, a safety card with information about IPV and community-based resources, and referral pathways to directly connect patients with support services. For the primary outcome, IPV-related interventions were shown to better inform patients of available IPV-related resources as compared to no intervention at all. For the secondary outcomes, screening and intervening on IPV were associated with improvements in patient perception of provider empathy (i.e., caring about safety) and safer responses by patients to unhealthy relationships. CONCLUSION: Screening for and intervening on IPV at abortion-related visits are associated with positive outcomes for patient safety and the patient-provider relationship. However, data on effective tools for identifying and supporting these patients are extremely limited. This review emphasizes the unmet need for implementation and evaluation of IPV-specific interventions during abortion-related clinical encounters. KEY POINTS: · The abortion visit offers a crucial setting to address IPV among a highly affected population.. · This study reviews others that analyzed interventions and associated outcomes for IPV at abortion-related visits.. · Appropriate interventions for IPV can improve patient-provider relationships and connect patients to essential resources..

Factors Associated with the Uptake of Long-acting Reversible Contraception and Contraceptive Use in Postpartum People with HIV at a Single Tertiary Care Center.

OBJECTIVE: This study aimed to elucidate factors contributing to uptake of highly effective contraception, including permanent contraception, and no contraceptive plan among postpartum people with HIV (PWHIV). STUDY DESIGN: A retrospective cohort analysis was conducted to correlate postpartum birth control (PPBC) with sociodemographic and biomedical variables among postpartum PWHIV who received care at The Ruth M. Rothstein CORE Center and delivered at John H. Stroger, Jr. Hospital of Cook County in Chicago, from 2012 to 2020. RESULTS: Earlier gestational age (GA) at initiation of prenatal care, having insurance, and increased parity are associated with uptake of highly effective contraception. Meanwhile, later GA at presentation increased odds of having no PPBC plan. CONCLUSION: Early prenatal care, adequate insurance coverage, and thorough PPBC counseling are important for pregnant PWHIV. KEY POINTS: · Contraceptive use among PWHIV is poorly understood.. · Having insurance and increased parity are associated with long-acting reversible contraception use.. · Earlier GA at first prenatal care visit is associated with increased PPBC uptake..

The use of adjunctive mechanical dilation at the time of induction termination and adverse health outcomes: a systematic review.

OBJECTIVE: This study aimed to assess if the use of mechanical dilation at the time of induction termination is associated with changes in the time from initiation of labor to expulsion of the fetus (induction-to-expulsion interval) and with the frequency of health complications when compared with medication management alone. DATA SOURCES: PubMed, CINAHAL, Scopus, and the Cochrane Central Register of Controlled Trials were queried from January 2000 to May 2023. STUDY ELIGIBILITY CRITERIA: We included randomized controlled trials of individuals who were assigned to undergo mechanical dilation (ie, laminaria, Dilapan-S, and intracervical Foley balloon catheter) in combination with the use of medication and compared it with the outcomes of medication use (eg, prostaglandins, antiprogestins, oxytocin) alone. METHODS: The primary outcome was the induction-to-expulsion interval. The secondary outcomes were the incidence of clinical chorioamnionitis, sepsis, hemorrhage, the need for blood transfusion and uterotonics, cervical laceration, the need for adjunctive procedures (eg, dilation and curettage), failed induction termination, uterine rupture, intensive care unit admission, or death. Assessment of bias was performed using the Cochrane Risk of Bias tool. A subgroup analysis was performed among studies deemed to be at low risk of bias. RESULTS: Of 864 abstracts identified, 11 met the inclusion criteria. Five studies demonstrated a shorter induction-to-expulsion interval among those randomized to mechanical dilation, whereas 6 studies demonstrated a similar or longer induction-to-expulsion interval. There were no significant differences reported in the frequency of any adverse outcomes between the trial arms. In addition, most studies (8/11) exhibited moderate to high levels of bias. In an analysis of the 3 studies deemed to have a low risk of bias, 1 (n=60) demonstrated a longer induction-to-expulsion interval with adjunctive laminaria, 1 (n=60) demonstrated a shorter induction-to-expulsion interval with adjunctive intracervical Foley balloon catheter use, and 1 demonstrated no difference in the induction-to-expulsion interval with adjunctive Dilapan-S use (n=180). CONCLUSION: Only a small number of studies, most of which were of low quality, assessed mechanical dilation for induction termination. The results of these studies were inconsistent in terms of the induction-to-expulsion interval of adjunctive mechanical methods in comparison with medication management alone. Studies did not reveal significant differences between the groups in adverse outcomes. Further research should investigate the use of mechanical dilation at the time of induction termination using high-quality methods.

Predictors of Preexposure Prophylaxis Eligibility among Pregnant People with Opioid Use Disorder.

OBJECTIVE: We seek to evaluate risk factors for eligibility for preexposure prophylaxis (PrEP) among pregnant people with opioid use disorder (OUD). STUDY DESIGN: This is a single-site retrospective cohort study of pregnant people admitted for management of OUD at an urban, tertiary care center from 2013 to 2022. PrEP eligibility was defined based on (1) modified American College of Obstetricians and Gynecologists' (ACOG) 2014 criteria: diagnosis of a sexually transmitted infection (STI), engagement in transactional sex work, intravenous drug use (IVDU), or incarceration and (2) modified 2021 Centers for Disease Control (CDC) criteria: diagnosis of bacterial STI (e.g., gonorrhea or syphilis) or transactional sex work. Risk factors associated with PrEP eligibility were evaluated using chi- square or Fischer's exact tests for categorical variables and t-tests or Wilcoxon rank-sum tests for continuous variables. Multivariable regression was used to control for confounding covariates, defined as p < 0.10 on bivariate analysis. p < 0.05 was used to indicate statistical significance. RESULTS: A total of 132 individuals met inclusion criteria, of whom 101 (76.5%) were deemed eligible for PrEP by meeting one or more modified 2014 ACOG criteria: 42 (31.8%) were incarcerated or had one or more STIs, while 30 (22.7%) endorsed engaging in transactional sex work and 68 (58.6%) endorsed IVDU. Using modified 2021 CDC criteria, 37 (28%) met PrEP eligibility, with 12 (9.1%) diagnosed specifically with a bacterial STI and 30 (22.7%) engaging in transactional sex work. Only comorbid psychiatric illness was associated with an increased risk for PrEP eligibility based on 2014 criteria, which persisted after controlling for maternal race/ethnicity (aRR 1.52, 95% confidence interval [CI] 1.24-1.86), and 2021 criteria, which persisted after controlling for nulliparity (aRR 2.12, 95% CI 1.30-3.57). CONCLUSION: A significant number of pregnant people with OUD meet one or more criteria for PrEP, with comorbid psychiatric conditions increasing the risk of meeting criteria. KEY POINTS: · Comorbid psychiatric illness is significantly associated with high risk of PrEP eligibility.. · A large proportion of pregnant individuals with active OUD meet criteria for PrEP prescribing.. · Risk-based screening algorithms for PrEP eligibility have limitations..

The association of out-of-hospital postpartum NSAID use and post-discharge hypertension control for people with hypertensive disorders of pregnancy.

OBJECTIVE: To evaluate the relationship between amount of NSAID use postpartum and outpatient blood pressure (BP) control. STUDY DESIGN: This is a prospective, single-site, cohort study of postpartum people diagnosed with HDP from 2018 to 2020 using the American College of Obstetrician and Gynecologists criteria. All participants were provided an electronic BP cuff for daily evaluation after discharge. Those who provided at least 7 days of data within the first 14 days after discharge were included. Standard PP pain management included ibuprofen 600 mg every 6 h as needed. The exposure was self-reported amount of NSAIDs used within the first 14 days after discharge. The primary outcome was median mean arterial pressure (MAP) over the first 14 days after hospital discharge. Secondary outcomes included median and maximum systolic and diastolic BPs and need for PP readmission for HDP. Regression models were created, controlling for a propensity score for highest quartile of NSAID use. RESULTS: 103 participants were approached, of whom 60 met inclusion criteria. Those who had a history of a cesarean delivery were more likely to be in the highest quartile of NSAID use; no other significant differences were noted across quartiles of NSAID use. There was no association between NSAID amount used and median MAP (adjusted ß coefficient 0.03, 95% CI: -0.17 to 0.22). There were no significant associations between NSAID amount used and all other secondary outcomes. CONCLUSION: Out-of-hospital NSAID use is not associated with worsened PP BP control after hospital discharge among people diagnosed with HDP.

How penalizing substance use in pregnancy affects treatment and research: a qualitative examination of researchers' perspectives.

Introduction: Laws regulating substance use in pregnancy are changing and may have unintended consequences on scientific efforts to address the opioid epidemic. Yet, how these laws affect care and research is poorly understood. Methods: We conducted semi-structured qualitative interviews using purposive and snowball sampling of researchers who have engaged pregnant people experiencing substance use. We explored views on laws governing substance use in pregnancy and legal reform possibilities. Interviews were double coded. Data were examined using thematic analysis. Results: We interviewed 22 researchers (response rate: 71 per cent) and identified four themes: (i) harms of punitive laws, (ii) negative legal impacts on research, (iii) proposals for legal reform, and (iv) activism over time. Discussion: Researchers view laws penalizing substance use during pregnancy as failing to treat addiction as a disease and harming pregnant people and families. Respondents routinely made scientific compromises to protect participants. While some have successfully advocated for legal reform, ongoing advocacy is needed. Conclusion: Adverse impacts from criminalizing substance use during pregnancy extend to research on this common and stigmatized problem. Rather than penalizing substance use in pregnancy, laws should approach addiction as a medical issue and support scientific efforts to improve outcomes for affected families.

The value and limitations of using predetermined criteria in decision making for maternal-fetal interventions.

Maternal-fetal interventions-such as prenatal fetal myelomeningocele (MMC) repair-are at the forefront of clinical innovation within maternal-fetal medicine, pediatric surgery, and neonatology. Many centers determine eligibility for innovative procedures using pre-determined inclusion and exclusion criteria based on seminal studies, for example, the "Management of Myelomeningocele Study" for prenatal MMC repair. What if a person's clinical presentation does not conform to predetermined criteria for maternal-fetal intervention? Does changing criteria on a case-by-case basis (i.e., ad hoc) constitute an innovation in practice and flexible personalized care or transgression of commonly held standards with potential negative consequences? We outline principle-based, bioethically justified answers to these questions using fetal MMC repair as an example. We pay special attention to the historical origins of inclusion and exclusion criteria, risks and benefits to the pregnant person and the fetus, and team dynamics. We include recommendations for maternal-fetal centers facing these questions.