Quantifying the association between doula care and maternal and neonatal outcomes.

BACKGROUND: The United States suffers from an increasing rate of severe maternal morbidity, paired with a wide disparity in maternal health by race. Doulas are posited to be a useful resource to increase positive outcomes and to decrease this disparity. OBJECTIVE: This study aimed to evaluate the association between doula care and a broad range of maternal and neonatal outcomes in various subpopulations. STUDY DESIGN: This was a retrospective cohort study of deliveries that were recorded from January 2021 to December 2022 at a single institution where they received prenatal care. The exposure was receipt of doula care prenatally and at delivery. We evaluated both the maternal (cesarean delivery, cesarean delivery of nulliparous, term, singleton, vertex infant, vaginal birth after cesarean, gestational hypertension, preeclampsia, postpartum emergency department visit, readmission, and attendance of postpartum office visit) and neonatal (neonatal intensive care unit admission, unexpected complications in term newborns, breastfeeding, preterm delivery, and intrauterine growth restriction) outcomes. Because our institution previously employed targeted outreach by offering doula services to patients at highest risk, we used multiple methods to generate an appropriate comparison population. We conducted a multivariate logistic regression and conditional regressions using propensity scores to model the likelihood of doula care to generate adjusted risk differences associated with doula care. Analyses were repeated in populations stratified by race (White vs Black) and then by payor status (public vs commercial). RESULTS: Our cohort included 17,831 deliveries; 486 of those received doula care and 17,345 did not. Patients who received doula care were more likely to self-report Black race, be publicly insured, and to live in a more disadvantaged neighborhood. Regardless of the analytical approach, for every 100 patients who received doula care, there were 15 to 34 more vaginal births after cesarean (adjusted risk difference, 15.6; 95% confidence interval, 3.8-27.4; adjusted risk difference, 34.2; 95% confidence interval, 0.046-68.0) and 5 to 6 more patients who attended a postpartum office visit (adjusted risk difference, 5.4; 95% confidence interval, 1.4-9.5; adjusted risk difference, 6.8; 95% confidence interval, 3.7-9.9) when compared with those who did not receive doula services. Infants born to these patients were 20% more like likely to be exclusively breastfed (adjusted risk ratio, 1.22; 95% confidence interval, 1.07-1.38), and doula care was associated with 3 to 4 fewer preterm births (adjusted risk difference, -3.8; 95% confidence interval, -6.1 to -1.5; -4.0; 95% confidence interval, -6.2 to -1.8) for every 100 deliveries that received doula care. Results were consistent regardless of race or insurance. Results were also consistent when doula care was redefined as having at least 3 prenatal encounters with a doula. CONCLUSION: Doula care was associated with more vaginal births after cesarean delivery, improved attendance of postpartum office visits, improved breastfeeding rates, and fewer preterm deliveries. The effect of doula care was consistent across race and insurance status.

Clinical Outcomes Associated With a Remote Postpartum Hypertension Monitoring Program.

OBJECTIVE: To evaluate differences in health care utilization and guideline adherence for postpartum individuals with hypertensive disorders of pregnancy (HDP) who are engaged in a remote monitoring program, compared with usual care. METHODS: This was a retrospective cohort study of postpartum individuals with HDP who delivered between March 2019 and June 2023 at a single institution. The primary exposure was enrollment in a remote hypertension management program that relies on patient home blood pressure (BP) measurement and centralized nursing team management. Patients enrolled in the program were compared with those receiving usual care. Outcomes included postpartum readmission, office visit within 6 weeks postpartum, BP measurement within 10 days, and initiation of antihypertensive medication. We performed multivariable logistic and conditional regression in a propensity score matched cohort. Propensity scores, generated by modeling likelihood of program participation, were assessed for even distribution by group, ensuring standardized bias of less than 10% after matching. RESULTS: Overall, 12,038 eligible individuals (6,556 participants, 5,482 in the control group) were included. Program participants were more likely to be White, commercially insured, be diagnosed with preeclampsia, and have higher prenatal and inpatient postpartum BPs. Differences in baseline factors were well-balanced after implementation of propensity score. Program enrollment was associated with lower 6-week postpartum readmission rates, demonstrating 1 fewer readmission for every 100 individuals in the program (propensity score-matched adjusted risk difference [aRD] -1.5, 95% CI, -2.6 to -0.46; adjusted risk ratio [aRR] 0.78, 95% CI, 0.65-0.93). For every 100 individuals enrolled in the program, 85 more had a BP recorded within 10 days (propensity score-matched aRD 85.4, 95% CI, 84.3-86.6), and six more had a 6-week postpartum office visit (propensity score-matched aRD 5.7, 95% CI, 3.9-7.6). Program enrollment was also associated with increased initiation of an antihypertensive medication postpartum (propensity score-matched aRR 4.44, 95% CI, 3.88-5.07). CONCLUSION: Participation in a postpartum remote BP monitoring program was associated with fewer postpartum hospital readmissions, higher attendance at postpartum visits, improved guideline adherence, and higher rates of antihypertensive use.

Postpartum Weight Change Association With Readmission and Blood Pressure Trend Among Individuals With Hypertensive Disorders of Pregnancy.

BACKGROUND: The aim of this study was to evaluate the association between early postpartum weight change and (1) hospital readmission and (2) 2-week blood pressure trajectory. METHODS AND RESULTS: This retrospective study cohort included 1365 individuals with a hypertensive disorder of pregnancy enrolled in a postpartum hypertension remote monitoring program. Exposure was percentage weight change from delivery to first weight recorded within 10 days postpartum. We first modeled likelihood of hospital readmission within 8 weeks postpartum using logistic regression adjusting for age, race, insurance, type of hypertensive disorder of pregnancy, early body mass index, gestational weight gain, mode of delivery, and any discharge antihypertensive medications. We then performed case-control analysis additionally matching in a 1:3 ratio on breastfeeding, early body mass index, discharge on antihypertensive medications, and days between weight measurements. Both analytic approaches were repeated, limiting to readmissions attributable to hypertension or heart failure. Finally, we compared blood pressure trajectories over first 2 weeks postpartum. Individuals who did not lose weight in the early postpartum period had more admissions compared with weight loss groups (group 3: 14.1% versus group 2: 5.8% versus group 1: 4.5%). These individuals had 4 times the odds of postpartum readmissions (adjusted odds ratio [aOR], 3.9 [95% CI, 1.8-8.6]) to 7 (aOR, 7.8 [95% CI, 2.3-26.5]) compared with those with the most weight loss. This association strengthened when limited to hypertension or heart failure readmissions. These individuals also had more adverse postpartum blood pressure trajectories, with significant differences by weight change group. CONCLUSIONS: Weight change is readily accessible and may identify individuals at high risk for postpartum readmission following a hypertensive disorder of pregnancy who could benefit from targeted interventions.

Postpartum Ambulatory Blood Pressure Patterns Following New-Onset Hypertensive Disorders of Pregnancy.

Importance: After a hypertensive disorder of pregnancy, hypertension can worsen in the postpartum period following hospital discharge. Risk factors for ongoing hypertension and associated outcomes have not been well characterized. Objective: To identify risk factors and characterize outcomes for individuals with ongoing hypertension and severe hypertension following hospital discharge post partum through a hospital system's remote blood pressure (BP) management program. Design, Setting, and Participants: This cohort study involved a population-based sample of individuals with a new-onset hypertensive disorder of pregnancy (preeclampsia or gestational hypertension) and no prepregnancy hypertension who delivered between September 2019 and June 2021. Participants were enrolled in a remote BP monitoring and management program at a postpartum unit at a referral hospital. Data analysis was performed from August 2021 to January 2023. Exposure: Inpatient postpartum BP categories. Main Outcomes and Measures: The primary outcomes were readmission and emergency department visits within the first 6 weeks post partum. Logistic regression was used to model adjusted odds ratios (aORs) and 95% CIs. Results: Of 2705 individuals in the cohort (mean [SD] age, 29.8 [5.7] years), 2214 (81.8%) had persistent hypertension post partum after hospital discharge, 382 (14.1%) developed severe hypertension after discharge, and 610 (22.6%) had antihypertensive medication initiated after discharge. Individuals with severe hypertension had increased odds of postpartum emergency department visits (aOR, 1.85; 95% CI, 1.17-2.92) and hospital readmissions (aOR, 6.75; 95% CI, 3.43-13.29) compared with individuals with BP normalization. When inpatient postpartum BP categories were compared with outpatient home BP trajectories to inform optimal thresholds for inpatient antihypertensive medication initiation, there was significant overlap between postdischarge BP trajectories among those with inpatient systolic BP greater than or equal to 140 to 149 mm Hg and/or diastolic BP greater than or equal to 90 to 99 mm Hg and those with systolic BP greater than or equal to 150 mm Hg and/or diastolic BP greater than or equal to 100 mm Hg. Conclusions and Relevance: This cohort study found that more than 80% of individuals with hypertensive disorders of pregnancy had ongoing hypertension after hospital discharge, with approximately 14% developing severe hypertension. These data support the critical role of remote BP monitoring programs and highlight the need for improved tools for risk stratification and consideration of liberalization of thresholds for medication initiation post partum.

The Contribution of Neighborhood Context to the Association of Race with Severe Maternal Morbidity.

OBJECTIVE: Severe maternal morbidity (SMM) has disproportionate frequencies among racial minorities and those of socioeconomic disadvantage, with people of Black race consistently having the highest proportion. Neighborhood level deprivation has been associated with maternal morbidity and mortality, including adverse pregnancy outcomes. We sought to explore the relationship between neighborhood socioeconomic disadvantage and SMM and describe how neighborhood context impacts the relationship between race and SMM. STUDY DESIGN: We performed a retrospective cohort analysis of all delivery admissions in a single health care network from 2015 to 2019. Area deprivation index (ADI) was used to represent neighborhood socioeconomic disadvantage and is a composite index of neighborhood that spans income, education, household characteristics, and housing. The index ranges from 1 to 100 with higher values indicating higher disadvantage. Logistic regression assessed the relationship between ADI and SMM and estimated the effect that ADI has on the relationship between race and SMM. RESULTS: Of the 63,208 birthing persons in our cohort, the unadjusted incidence of SMM was 2.2%. ADI was significantly associated with SMM, with higher values conferring higher risk for SMM (p < 0.001). The absolute risk of SMM increased roughly by 1.0% from the lowest to highest ADI value. Those of Black race had the highest unadjusted incidence of SMM compared with the referent group (3.4 vs. 2.0%) and highest median ADI (92; interquartile range [IQR]: 20). In the multivariable model, in which the primary exposure was race and ADI was adjusted for, Black race had a 1.7 times odds SMM when compared with White race (95% confidence interval [CI]: 1.5-1.9). This association was attenuated to 1.5 adjusted odds when controlling for ADI (95% CI: 1.3-1.7). Risk attenuation for SMM was not seen in other race categories. CONCLUSION: Neighborhood context contributes to SMM but does not explain the majority of racial disparities. KEY POINTS: · Neighborhood context is associated with SMM, with higher disadvantage conferring higher risk.. · Compared with White race, all other races had higher rates of SMM, with Black race having the highest.. · Accounting for neighborhood modestly attenuates the magnitude of association of Black race with SMM.. · Neighborhood context contributes to health outcomes but does not explain the majority of disparities..

Factors associated with postpartum initiation of anti-hypertensive medication after hospital discharge among individuals with hypertensive disorders of pregnancy in a remote monitoring program.

Importance: Following a hypertensive disorder of pregnancy, hypertension can worsen in the postpartum period following hospital discharge. Risk factors for hypertension exacerbation and associated outcomes have not been well characterized. Objective: We sought to identify risk factors and characterize outcomes for individuals requiring initiation of anti-hypertensive medication following hospital discharge postpartum through our hospital system's remote blood pressure management program. Design: We performed a cohort study of individuals delivered between 9/2019-6/2021 and enrolled in our remote blood pressure monitoring program, which utilizes standardized protocols for anti-hypertensive medication initiation postpartum. Setting: Postpartum unit at a referral hospital. Participants: Population-based sample of individuals with a hypertensive disorder of pregnancy (HDP, preeclampsia or gestational hypertension) and no pre-pregnancy hypertension. Exposure: Anti-hypertensive medication initiation timing: no anti-hypertensive medications, initiation prior to hospital discharge postpartum, and initiation after hospital discharge postpartum. Main outcomes: Postpartum readmission and emergency room visits. Results: Of 2,705 individuals in our cohort, 1,458 (54%) required no anti-hypertensive medications postpartum, 637 individuals (24%) were discharged on anti-hypertensive medications, and 610 (23%) required initiation of anti-hypertensive agents after discharge. Utilizing an inpatient threshold of ≥ 150/100 mmHg in line with current obstetric guidelines for medication initiation postpartum fails to identify 385 (63%) of individuals who required medication initiation after discharge. These individuals had higher home blood pressures, increased odds of Emergency Room visits [aOR 2.22 (95%CI 1.65-2.98)] and hospital readmissions postpartum [aOR 5.73 (95%CI 3.72-8.82)] compared with individuals discharged on no medications. Conclusions and Relevance: Over 20% of individuals with hypertensive disorders of pregnancy required initiation of anti-hypertensive medications after hospital discharge. Current blood pressure guidelines for medication initiation fail to identify the majority of these individuals during delivery hospitalization. These data support the critical role of remote blood pressure monitoring programs and highlight the need for improved tools for risk strati cation and liberalization of thresholds for medication initiation postpartum.

Comparative Analysis of Obstetric Hemorrhage Risk Prediction Tools.

OBJECTIVE: Hemorrhage risk prediction tools were developed in response to rising rates of obstetric hemorrhage (OBH). The California Maternal Quality Care Collaborative (CMQCC) risk prediction tool classifies patients as low, medium, and high risk for OBH based on individual risk factors. At our institution, Magee-Womens Hospital (MWH), a unique OBH risk prediction tool was derived from the CMQCC tool that differs through its use of weighted risk factors and distinctive laboratory value cutoffs. Our objective is to compare this enhanced institution-specific tool to the CMQCC tool. STUDY DESIGN: This study was a retrospective cohort analysis of delivery admissions from a single health care network. Admission OBH risk scores were assigned to each patient using both the MWH and CMQCC scores. Cohen's kappa estimated agreement. Scoring systems and maternal outcomes were compared using chi-square test. Composite morbidity included transfusion, hysterectomy, uterine artery embolization, and intensive care unit admission. RESULTS: A total of 21,843 delivery admissions were included. A moderate association was observed between scoring systems (kappa = 0.41, p < 0.001). The CMQCC tool categorized 16,184 (74%) patients as low risk, 4,664 (21%) as medium risk, and 995 (5%) as high risk. The MWH tool categorized 13,137 (60%) patients as low risk, 8,113 (37%) as medium risk, and 593 (3%) as high risk. The MWH score recategorized CMQCC low-risk patients to a higher stratum 26% of the time. CMQCC high-risk patients were recategorized to a lower stratum 82% of the time. Both the MWH and CMQCC tools were able to differentiate OBH-related morbidity across risk strata. The MWH tool independently predicted risk of composite morbidity within each stratum of the CMQCC score. CONCLUSION: Both the MWH and CMQCC tools independently distinguish risk of composite morbidity. Adding weighted values to individual risk factors further discriminates risk of morbidity. This suggests it may be reasonable to adapt the CMQCC tool to reflect institutional populations and resources. KEY POINTS: · The nationally adopted CMQCC risk prediction tool identifies women at risk for obstetric hemorrhage.. · Our institution (MWH) developed a unique tool that weights individual risk factors to better capture risk.. · The CMQCC and MWH tools both differentiate risk; though similar to other tools, categorize a proportion of women who hemorrhage as low risk..

Neighborhood disadvantage and the racial disparity in postpartum hypertension.

BACKGROUND: Postpartum hypertension is the leading cause of postpartum readmission and has long-lasting cardiovascular effects. Black patients have higher incidence rates of hypertensive disorders after delivery and subsequent severe maternal morbidity. Neighborhood advantage, a marker of social determinants of health, has not been studied concerning postpartum hypertension. Moreover, the interplay between race and neighborhood advantage and their effect on postpartum hypertension have not been previously explored. OBJECTIVE: This study aimed to evaluate the association between neighborhood-level social determinants of health and postpartum hypertension and explore whether these factors explain previously documented racial disparities. STUDY DESIGN: This study included a retrospective cohort of people enrolled in a remote monitoring program of postpartum hypertension at the time of delivery within 1 health network from March 2019 to September 2021. Patients were eligible for enrollment after a diagnosis of hypertensive disorder during pregnancy or delivery. We further limited the cohort to self-reported Black and White patients with blood pressures recorded at 3 weeks and 6 weeks postpartum. The neighborhood advantage for each person at the time of delivery was classified using the area deprivation index, an accepted surrogate of social determinants of health and our primary exposure. The secondary exposure was self-reported race. Study outcomes of interest were hypertensive status (stage 1 hypertension: ≥130 to 139/80 to 89 mm Hg; stage 2 hypertension: ≥140/90 mm Hg) at 3 and 6 weeks after delivery. In addition, hypertensive status by neighborhood area deprivation index using logistic regression was molded. In secondary analyses, a case-control cohort matched on the area deprivation index was created, and conditional logistic regression was used to evaluate race. Finally, mixed-effects models modeling hypertension by race and clustering within the area deprivation index were used. RESULTS: Of 4193 people enrolled, 2722 were Black or White and had blood pressure data recorded at 3 weeks after delivery, and 1126 had blood pressure data recorded at 6 weeks after delivery. After accounting for prenatal body mass index, smoking status, type of hypertension, and antihypertensives prescribed at discharge, persons living in the most disadvantaged neighborhoods were twice as likely (adjusted odds ratio, 2.03; 95% confidence interval, 1.53-2.69) to develop stage 2 hypertension at 21 days after delivery and 1.67 times more likely (95% confidence interval, 1.06-2.64) to develop stage 2 hypertension at 6 weeks after delivery than persons living in the most advantaged neighborhoods. Both associations were attenuated after adjusting for race. When people with stage 2 hypertension were matched on area deprivation index with normotensive counterparts, Black patients were still 3 to 4 times more likely to develop stage 2 hypertension at 3 (adjusted odds ratio, 3.00; 95% confidence interval, 1.95-4.63) and 6 (adjusted odds ratio, 4.61; 95% confidence interval, 2.05-10.36) weeks after delivery. This association remained after clustering within a neighborhood at 3 (adjusted odds ratio, 3.12; 95% confidence interval, 2.41-4.06) and 6 (adjusted odds ratio, 2.99; 95% confidence interval, 1.96-4.54) weeks after delivery. There was no significant difference in stage 1 hypertension. CONCLUSION: Neighborhood advantage was associated with the development of persistent hypertension at 3 and 6 weeks after delivery. This association did not explain the racial disparity in sustained high blood pressure.

Monoclonal Antibodies for Treatment of SARS-CoV-2 Infection During Pregnancy : A Cohort Study.

BACKGROUND: Monoclonal antibody (mAb) treatment decreases hospitalization and death in high-risk outpatients with mild to moderate COVID-19. However, no studies have evaluated adverse events and effectiveness of mAbs in pregnant persons compared with no mAb treatment. OBJECTIVE: To determine the frequency of drug-related adverse events and obstetric-associated safety outcomes after treatment with mAb compared with no mAb treatment of pregnant persons, and the association between mAb treatment and a composite of 28-day COVID-19-related hospital admission or emergency department (ED) visit, COVID-19-associated delivery, or mortality. DESIGN: Retrospective, propensity score-matched, cohort study. SETTING: UPMC Health System from 30 April 2021 to 21 January 2022. PARTICIPANTS: Persons aged 12 years or older with a pregnancy episode and any documented positive SARS-CoV-2 test (polymerase chain reaction or antigen test). INTERVENTION: Bamlanivimab and etesevimab, casirivimab and imdevimab, or sotrovimab treatment compared with no mAb treatment. MEASUREMENTS: Drug-related adverse events, obstetric-associated safety outcomes among persons who delivered, and a risk-adjusted composite of 28-day COVID-19-related hospital admission or ED visit, COVID-19-associated delivery, or mortality. RESULTS: Among 944 pregnant persons (median age [interquartile range (IQR)], 30 years [26 to 33 years]; White (79.5%; n = 750); median Charlson Comorbidity Index score [IQR], 0 [0 to 0]), 552 received mAb treatment (58%). Median gestational age at COVID-19 diagnosis or treatment was 179 days (IQR, 123 to 227), and most persons received sotrovimab (69%; n = 382). Of those with known vaccination status, 392 (62%) were fully vaccinated. Drug-related adverse events were uncommon (n = 8; 1.4%), and there were no differences in any obstetric-associated outcome among 778 persons who delivered. In the total population, the risk ratio for mAb treatment of the composite 28-day COVID-19-associated outcome was 0.71 (95% CI, 0.37 to 1.4). The propensity score-matched risk ratio was 0.61 (95% CI, 0.34 to 1.1). There were no deaths among mAb-treated patients compared with 1 death in the nontreated control patients. There were more non-COVID-19-related hospital admissions in the mAb-treated persons in the unmatched cohort (14 [2.5%] vs. 2 [0.5%]; risk ratio, 5.0; 95% CI, 1.1 to 21.7); however, there was no difference in the propensity score-matched rates, which were 2.5% mAb-treated vs. 2% untreated (risk ratio, 1.3; 95% CI, 0.58% to 2.8%). LIMITATIONS: Drug-related adverse events were patient and provider reported and potentially underrepresented. Symptom severity at the time of SARS-CoV-2 testing was not available for nontreated patients. CONCLUSION: In pregnant persons with mild to moderate COVID-19, adverse events after mAb treatment were mild and rare. There was no difference in obstetric-associated safety outcomes between mAb treatment and no treatment among persons who delivered. There was no difference in 28-day COVID-19-associated outcomes and non-COVID-19-related hospital admissions for mAb treatment compared with no mAb treatment in a propensity score-matched cohort. PRIMARY FUNDING SOURCE: No funding was received for this study.

CA-125 monitoring in gynecologic cancer patients with COVID-19: A case series.

CA-125 has long been utilized as a surveillance biomarker for gynecologic malignancies but can be elevated in other conditions, including infection. A study of tumor markers in non-cancer patients saw a rise in CA-125 values during severe COVID-19 infections. Given the potential confounding effect this could have on surveillance and treatment planning, we sought to describe the impact of COVID-19 on CA-125 trends in a gynecologic oncology patient population. We conducted a retrospective chart review of patients treated at a UPMC hospital during the COVID-19 pandemic from March of 2020 through September of 2021. Patients were included for analysis if they had confirmed uterine or ovarian malignancies, a COVID-19 infection and more than one CA-125 value drawn within one year of their COVID-19 diagnosis. The CA-125 values were plotted against the timeline of their COVID-19 infections to assess for trends in CA-125 during and after infection. There were 17 patients who met the above criteria. Of these 17 patients, three had a rise in their CA-125 trend at the time of their COVID-19 diagnosis. Another three had newly elevated CA-125 values, without a prior documented baseline level, at the time of their infection. In all six of these patients, their CA-125 elevations could be attributed to malignancy. The remaining 11 patients showed stable or decreasing CA-125 values coinciding with their COVID-19 infection. This case series illustrates that while CA-125 values may increase during an acute COVID-19 infection, cancer remains the most likely cause of a CA-125 increase. Clinical suspicion should remain high for a possible change in cancer status.

Breast cancer mortality as a function of age.

BACKGROUND: Incidence of breast cancer (BC) in US women continues to increase with age as the strongest risk factor. We aimed to compare clinical, pathological and sociological variables associated to BC diagnosis, as well as the relative mortality rates of BC patients compared to the general US population. METHODS: We performed a retrospective, single-institution study evaluating 52,509 patients diagnosed with unilateral BC at the University of Pittsburgh Medical Center (UPMC) between 1990-2020. Primary outcome was death from any cause with cancer recurrence as a secondary outcome, evaluated for 4 age groups: 20-44, 45-55, 56-69, and 70-90. A dataset of expected mortality for women in the general population over a 10-year period was constructed using the Surveillance, Epidemiology, and End Results (SEER) Program. Observed vs. expected mortality and standardized mortality ratios (SMR) for each age group were calculated. RESULTS: Youngest patients with BC demonstrated the highest SMR at 10-year follow-up from time of diagnosis compared to the general US population (SMR 9.68, 95% CI: 8.99to 10.42), and remained highest compared to other age groups when analysis was limited to Stage 0/1 disease (10-year SMR 3.11, 95% CI: 2.54 to 3.76). SMRs decreased with increasing age at diagnosis with an SMR <1.0 in patients diagnosed with stage 0/1 at ages 70-90 at 5-year follow-up. CONCLUSIONS: Younger BC patients have the highest SMR which declines gradually with age. In the elderly, lower stage 0/1 SMR's are found compared to the general population, suggesting the possibility of an associated protective effect.

Metformin and survival: Is there benefit in a cohort limited to diabetic women with endometrial, breast, or ovarian cancer?

OBJECTIVE: Evaluate the association between metformin and survival in women with Type 2 diabetes (T2DM) and breast, endometrial and ovarian cancer- 3 hormonally mediated cancers. METHODS: We evaluated outcomes in a cohort of 6225 women with T2DM with a new diagnosis of ovarian, breast or endometrial cancer from 2010 to 2019. We classified glycemic medications at time of first cancer diagnosis into 3 tiers in accordance with ADA guidelines. Approaches compared: (i) metformin (tier 1) vs. no glycemic medication, (ii) metformin vs tier 2 medications (sulfonylureas, thiazolidinediones, SGLT2-inhibitors, DPP4-inhibitors, alpha glucosidase-inhibitors, GLP-1 agonists), (iii) metformin vs tier 3 medications (insulins, amylinomimetics), and (iv) tier 2 vs tier 3 medications. Analyses included Cox proportional-hazards models, Kaplan-Meier curves, and conditional logistic regression in a risk set-sampled nested case-control matched on T2DM duration- all modeling survival. Models were adjusted for demographics, cancer type, A1C, T2DM duration, and number of office visits and hospitalizations. RESULTS: Metformin was the most used medication (n = 3232) and consistently demonstrated survival benefit compared with tier 2 and 3 medications, across all methods. Tier 3-users demonstrated highest risk of death when compared to metformin rather than tier 2 [adjHR = 1.83 (95% CI: 1.58, 2.13) vs. adjHR = 1.32 (95% CI: 1.11, 1.57)], despite similar baseline profiles between tier 1 and 2 users. CONCLUSIONS: Metformin users experienced increased survival even after accounting for surrogates of diabetes progression. Benefit extended beyond that seen in tier 2-users. Our findings, consistent with prior studies, indicate metformin use improves survival in women with T2DM and hormonally mediated women's cancers.

Recurrent Preterm Birth Reduction by 17-Hydroxyprogesterone Caproate in Dichorionic/Diamniotic Twin Gestation.

OBJECTIVE: The study aimed to evaluate the impact of 17-hydroxyprogesterone caproate (17-OHPC) on recurrent preterm birth (PTB) in women with a prior PTB and a current dichorionic/diamniotic twin gestation. STUDY DESIGN: We combined individual patient-level data from two prospective randomized placebo-controlled trials of prophylactic 17-OHPC in twin gestation and compared the rates of recurrent spontaneous PTB in those women with a prior singleton PTB randomized to placebo or 17-OHPC (250 mg weekly). RESULTS: Only 7.4% of women with dichorionic/diamniotic twin gestation experienced a prior PTB. Among these 66 women, spontaneous delivery prior to 34 weeks occurred significantly less often (p = 0.03) in those randomized to 17-OHPC (20.6%) than in those randomized to placebo (46.9%). However, mean gestational length was not significantly different, and there was no statistically significant difference in composite neonatal outcome. CONCLUSION: 17-OHPC may be beneficial to women with a prior PTB and a current dichorionic/diamniotic twin gestation. These findings along with those reported by the Maternal Fetal Medicine Units Network in singletons suggest a common mechanism of action and a specific target population, those with a prior PTB, that may benefit from 17-OHPC treatment. A large prospective trial is needed to validate these findings. KEY POINTS: · 17-OHPC reduces recurrent PTB in women with dichorionic/diamniotic twins.. · PTB risk and response to 17-OHPC may differ according to the type of twinning.. · 17-OHPC may affect a common pathway in twins and singletons with a prior PTB..

Correlation between hemorrhage risk prediction score and severe maternal morbidity.

BACKGROUND: Obstetrical hemorrhage is a leading cause of severe maternal morbidity, a key indicator of a nation's healthcare delivery system and often associated with a high rate of preventability. Limited data suggest that a patient's hemorrhage risk score may be associated with risk for maternal morbidity such as severe hemorrhage, intensive care unit admission, or transfusion. Little is known regarding the relationship between hemorrhage risk score and nontransfusion-related morbidity. OBJECTIVE: We sought to evaluate the association between a patient's California Maternal Quality Care Collaborative admission hemorrhage risk score and severe maternal morbidity. STUDY DESIGN: This was a retrospective cohort of delivery admissions from 2018 to 2019 in a single healthcare network. Admission risk scores were assigned to each patient using the California Maternal Quality Care Collaborative criteria. Rates of transfusion- and nontransfusion-associated severe maternal morbidity were compared across low-, medium-, and high-risk strata. We defined severe maternal morbidity as the presence of any International Classification of Diseases diagnosis or procedure codes outlined by the Centers for Disease Control and Prevention, need for intensive care unit admission, or prolonged postpartum hospital length of stay. A multivariable logistic regression was used to assess the association between hemorrhage risk score and severe maternal morbidity. RESULTS: In the overall cohort, severe maternal morbidity occurred in 2.4% (n=517) of all deliveries. Excluding cases requiring transfusion, 0.6% (n=131) of cases still had a severe maternal morbidity event. The incidence of severe maternal morbidity was 1.6% (n=264) in patients categorized as low risk for hemorrhage compared with 2.5% (n=118) and 13.6% (n=135) in patients who were categorized as medium or high risk for hemorrhage, respectively (P<.001). Patients classified as high risk had a significant association with both severe maternal morbidity (adjusted odds ratio, 8.8; 95% confidence interval, 7.0-11) and nontransfusion-associated severe maternal morbidity (adjusted odds ratio, 3.6; 95% confidence interval, 2.2-5.9). CONCLUSION: In addition to predicting the risk for obstetrical hemorrhage and transfusion, our findings indicate that the California Maternal Quality Care Collaborative admission hemorrhage risk tool predicts risk for transfusion- and nontransfusion-associated severe maternal morbidity. Our findings imply that despite awareness and the identification of patients at high risk for obstetrical hemorrhage on admission, significant hemorrhage-associated morbidity persisted. Our data indicate that the identification of risk alone may be insufficient to reduce morbidity and imply that further work is needed to investigate and implement new practices in response to a patient's score stratum.

What is driving the decreased incidence of preterm birth during the coronavirus disease 2019 pandemic?

BACKGROUND: Institutions across the world have observed a decrease in the incidence of preterm births during the coronavirus disease 2019 pandemic. The reason for this reduction remains unknown. OBJECTIVE: We sought to explore potential causes for the decrease in preterm births by exploring the following 3 hypotheses: (1) do women who are more likely to be able to work from home incur less physical/or emotional stress resulting in longer gestation? (2) Does the effect of the coronavirus disease 2019 pandemic on the incidence of preterm births vary by race? (3) Is this change provider driven? STUDY DESIGN: Using a retrospective cohort of all singleton deliveries at a single tertiary care center, we compared the deliveries for the period before the coronavirus disease 2019 pandemic (January 1, 2018-January 31, 2020) with those occurring during the pandemic (April 1, 2020-October 27, 2020). Comparisons between the period before and during the pandemic were made using Pearson chi-square or t tests as appropriate. The overall incidence of preterm birth, defined as delivery at <37 weeks' gestation, was analyzed and then further classified into spontaneous or indicated preterm births. The population was then stratified by the following categories: (1) insurance type and neighborhood disadvantage; (2) race; and (3) provider type. The provider type was classified as delivery occurring within an outpatient care facility, a clinic that provides prenatal care to those eligible for medical assistance, or a nonoutpatient care facility. RESULTS: In a population of 17,687 pre-coronavirus disease 2019 deliveries, and 5396 deliveries occurring during the coronavirus disease 2019 pandemic, there was a significant decrease in the overall incidence of preterm births (11.1 vs 10.1%; P=.039). Both spontaneous and indicated preterm deliveries decreased across the entire population. When stratified, decreases in the incidence of spontaneous preterm birth before vs during the coronavirus disease 2019 pandemic were limited to deliveries to women from more advantaged neighborhoods (most advantaged, 4.4 vs 3.8%; least advantaged, 7.2 vs 7.4%), white mothers (white, 5.6 vs 4.7%; black, 6.6 vs 7.1%), and those receiving care from nonoutpatient care providers (nonoutpatient care providers, 5.5 vs 4.8%; outpatient care providers, 6.3 vs 6.7%). CONCLUSION: The incidence of preterm births has decreased during the coronavirus disease 2019 pandemic. Decreases in the rate of spontaneous preterm births were limited to deliveries to white women, living in more advantaged neighborhoods, and deliveries at nonoutpatient care facilities. The coronavirus disease 2019 response regulations may have benefited women with more indicators of advantage disproportionately more.

Racial Differences in Postpartum Blood Pressure Trajectories Among Women After a Hypertensive Disorder of Pregnancy.

Importance: Maternal morbidity and mortality are increasing in the United States, most of which occur post partum, with significant racial disparities, particularly associated with hypertensive disorders of pregnancy. Blood pressure trajectory after a hypertensive disorder of pregnancy has not been previously described. Objectives: To describe the blood pressure trajectory in the first 6 weeks post partum after a hypertensive disorder of pregnancy and to evaluate whether blood pressure trajectories differ by self-reported race. Design, Setting, and Participants: This prospective cohort study included deliveries between January 1, 2018, and December 31, 2019. Women with a clinical diagnosis of a hypertensive disorder of pregnancy were enrolled in a postpartum remote blood pressure monitoring program at the time of delivery and were followed up for 6 weeks. Statistical analysis was performed from April 6 to 17, 2020. Main Outcomes and Measures: Mixed-effects regression models were used to display blood pressure trajectories in the first 6 weeks post partum. Results: A total of 1077 women were included (mean [SD] age, 30.2 [5.6] years; 804 of 1017 White [79.1%] and 213 of 1017 Black [20.9%]). Systolic and diastolic blood pressures were found to decrease rapidly in the first 3 weeks post partum, with subsequent stabilization (at 6 days post partum: mean [SD] peak systolic blood pressure, 146 [13] mm Hg; mean [SD] peak diastolic blood pressure, 95 [10] mm Hg; and at 3 weeks post partum: mean [SD] peak systolic blood pressure, 130 [12] mm Hg; mean [SD] peak diastolic blood pressure, 85 [9] mm Hg). A significant difference was seen in blood pressure trajectory by race, with both systolic and diastolic blood pressure decreasing more slowly among Black women compared with White women (mean [SD] peak systolic blood pressure at 1 week post partum: White women, 143 [14] mm Hg vs Black women, 146 [13] mm Hg; P = .01; mean [SD] peak diastolic blood pressure at 1 week post partum: White women, 92 [9] mm Hg vs Black women, 94 [9] mm Hg; P = .02; and mean [SD] peak systolic blood pressure at 3 weeks post partum: White women, 129 [11] mm Hg vs Black women, 136 [15] mm Hg; P < .001; mean [SD] peak diastolic blood pressure at 3 weeks post partum: White women, 84 [8] mm Hg vs Black women, 91 [13] mm Hg; P < .001). At the conclusion of the program, 126 of 185 Black women (68.1%) compared with 393 of 764 White women (51.4%) met the criteria for stage 1 or stage 2 hypertension (P < .001). Conclusions and Relevance: This study found that, in the postpartum period, blood pressure decreased rapidly in the first 3 weeks and subsequently stabilized. The study also found that, compared with White women, Black women had a less rapid decrease in blood pressure, resulting in higher blood pressure by the end of a 6-week program. Given the number of women with persistent hypertension at the conclusion of the program, these findings also appear to support the importance of ongoing postpartum care beyond the first 6 weeks after delivery.

Survival and recurrence after intraperitoneal chemotherapy use: Retrospective review of ovarian cancer hospital registry data.

BACKGROUND: Intraperitoneal/intravenous chemotherapy (IP/IV) was associated with improved survival for ovarian cancer (OC) patients in several randomized clinical trials. However, the uptake of IP/IV in clinical practice is varied due to conflicting evidence about its impact on survival and recurrence. The aim of this study was to explore the uptake of IP/IV treatment and to evaluate its impact on survival and recurrence in OC patients. METHODS: Demographic and clinical information on OC patients (N = 2916) who underwent treatment for OC between 2000 and 2017 was obtained from the large healthcare system cancer registry. Duplicate records, grade 1, rare (eg, gelatinous carcinoma), and non-epithelial (eg, granulosa cell carcinoma) tumors were excluded. Kaplan-Meier survival curves were constructed to compare 5- and 10-year survival based on the chemotherapy type, surgery type, and stage. Multivariable Gray's piecewise constant time-varying coefficient models were fitted to evaluate the effect of IP/IV on adjusted hazard ratio (AHR) of OC survival and recurrence adjusting for potential confounders. RESULTS: The final sample consisted of 1846 OC patients, 14% (250/1846) of which received IP/IV chemotherapy. IP/IV was significantly associated with improved 10-year survival (P < .001). Multivariable Gray's model demonstrated that IP/IV therapy significantly reduced the AHR of death (AHR = 0.39-1.07, P < .001) with the beneficial effect gradually declining over time. Use of IP/IV chemotherapy had no impact on OC recurrence. CONCLUSIONS: These findings demonstrated that only a small fraction of eligible patients underwent IP/IV chemotherapy. We report a significant 10-year survival, but not necessarily recurrence benefit is associated with IP/IV chemotherapy compared to IV only, suggesting the need for novel ways of identifying patients who may benefit from IP/IV chemotherapy.

Ondansetron use in the first trimester of pregnancy and the risk of neonatal ventricular septal defect.

BACKGROUND: Literature is divided regarding the risk of neonatal ventricular septal defect (VSD) associated with first trimester ondansetron use in pregnancy. METHODS: We evaluated the risk of VSD associated with first trimester exposure to intravenous or oral ondansetron in 33 677 deliveries at Magee-Womens Hospital in Pittsburgh, PA (2006-2014). Using log-binomial regression, we evaluated the risk: (1) in the full cohort, (2) using propensity score designs with both matching and inverse probability weighting and (3) utilizing clustered trajectory analysis evaluating the role of dose. Sensitivity analyses assessed the association between ondansetron and all recorded birth defects in aggregate. RESULTS: A total of 3733 (11%) pregnancies were exposed to ondansetron in the first trimester (dose range: 2.4-1008 mg). Ondansetron was associated with increased risk of VSD with risk ratios ranging from 1.7 [95% confidence interval (CI) 1.0-2.9] to 2.1 (95% CI 1.1-4.0) across methods. Risks correspond to one additional VSD for approximately every 330 pregnancies exposed in the first trimester. The association was dose-dependent with increased risk in women receiving highest cumulative doses compared with lowest doses [adjusted risk ratio: 3.2 (95% CI 1.0-9.9)]. The association between ondansetron and congenital malformations was diluted as the outcome included additional birth defects. CONCLUSIONS: First trimester ondansetron use is associated with an increased risk of neonatal VSD potentially driven by higher doses. This risk should be viewed in the context of risks attributable to severe untreated nausea and vomiting of pregnancy.

A Postpartum Remote Hypertension Monitoring Protocol Implemented at the Hospital Level.

OBJECTIVE: To evaluate the feasibility, acceptability, and compliance of a remote blood pressure monitoring protocol implemented as a quality improvement measure at the hospital level for management of hypertension in postpartum women after hospital discharge. METHODS: This is an ongoing quality improvement project that included women admitted to the postpartum unit of a single tertiary care hospital. We designed nursing call center-driven blood pressure management and treatment algorithms, which were initiated after hospital discharge until 6 weeks postpartum. Women are eligible to participate if they have a diagnosis of chronic hypertension, superimposed preeclampsia, gestational hypertension, preeclampsia, or postpartum hypertension and have access to a text messaging-enabled smartphone device. After identification by an obstetric care provider, women are enrolled into the program, which is automatically indicated in the electronic medical record. Maternal, obstetric, and sociodemographic data were obtained from the electronic medical record. RESULTS: Between February 2018 and January 2019, we enrolled 499 patients. Here we report on the first 409 enrolled patients. Participants include 168 (41%) with gestational hypertension, 179 (44%) with preeclampsia with no history of chronic hypertension, 49 (12%) with chronic hypertension with superimposed preeclampsia, and 13 (3%) with postpartum preeclampsia. One hundred seventy-one (42%) participants had antihypertensives initiated or titrated through the program. Three hundred forty women (83%) continued the program beyond 3 weeks postpartum, and 360 (88%) attended an in-person 6-week postpartum visit. Two hundred thirty-five out of 250 women who completed a postprogram survey (94%) reported satisfaction with the program. CONCLUSION: In this study, we detail results from an ongoing remote blood pressure monitoring program. We demonstrate high compliance, retention, and patient satisfaction with the program. This is a feasible, scalable remote monitoring program connected to the electronic medical record.