Continuous glucose monitoring in pregnancies with type 1 diabetes: small increases in time-in-range improve maternal and perinatal outcomes.

BACKGROUND: Continuous glucose monitors provide detailed information regarding glycemic control in pregnant patients with type 1 diabetes. Little data have been published examining the association between continuous glucose monitor parameters and perinatal outcomes among gravidas with type 1 diabetes using continuous glucose monitors. OBJECTIVE: This study aimed to examine the association between perinatal outcomes and time-in-range as assessed by continuous glucose monitors used in pregnant individuals with type 1 diabetes. We hypothesized that higher time-in-range would be associated with lower risk of adverse perinatal outcomes. STUDY DESIGN: This multicenter retrospective cohort study included all gravidas with type 1 diabetes using continuous glucose monitors who delivered from 2020 to 2022 at 5 University of California sites. Only those with continuous glucose monitor target range set to 70 to 140 mg/dL (±10 mg/dL) were included. Time-in-range (%) was recorded at 12, 16, 20, 24, 28, and 32 weeks. The primary maternal and neonatal outcomes were preeclampsia and large for gestational age, defined as birthweight ≥95th percentile. Kruskal-Wallis tests were used to compare median time-in-range between those with and without the primary outcomes. Log-binomial regression was used to obtain risk ratios, with adjustment for microvascular disease and years with type 1 diabetes. RESULTS: A total of 91 patients were included. Most used an insulin pump (81%) and did not have diabetic microvascular disease (72%). Median time since diagnosis of type 1 diabetes was 16 years, and median periconception hemoglobin A1c was 6.7%. Compared with those with preeclampsia, normotensive gravidas had significantly higher time-in-range at nearly every time point. A similar pattern was observed for those with normal-birthweight infants compared with large-for-gestational-age infants. On adjusted analyses, every 5-unit increase in time-in-range at 12 weeks was associated with 45% and 46% reductions in the risks of preeclampsia and large for gestational age, respectively (preeclampsia: adjusted risk ratio, 0.55; 95% confidence interval, 0.30-0.99; large for gestational age: adjusted risk ratio, 0.54; 95% confidence interval, 0.29-0.99). CONCLUSION: Higher time-in-range is associated with lower risk of preeclampsia and large for gestational age. This association is observed early in gestation, when each 5-unit increase in time-in-range is associated with ∼50% reduction in the risk of these complications. These findings can be used to counsel patients regarding the risk of pregnancy complications at specific time-in-range values, and to encourage patients that even small improvements in time-in-range can have significant impact on pregnancy outcomes. Larger studies are needed to further explore these findings and to identify optimal time-in-range to reduce perinatal complication rates.

Immediate Postpartum Breastfeeding following Pregnancy with Cardiac Disease.

OBJECTIVE: This study aimed to identify predictors of immediate postpartum breastfeeding among women with maternal cardiac disease (MCD). STUDY DESIGN: This study included all gravidas with MCD who delivered at a single institution from 2012 to 2018. Charts were abstracted for maternal demographics, obstetrical outcome, cardiac diagnoses, cardiac risk stratification scores, and prepregnancy echocardiogram findings. Kruskal-Wallis and Fisher's exact tests were used to compare the breastfeeding (BF) group versus the nonbreastfeeding (NBF) group. Logistic regression was used to obtain odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: Among 211 gravidas with MCD, 12% were not breastfeeding at the time of postpartum hospital discharge. Compared with the BF group, the NBF group had a significantly higher proportion of women with cardiomyopathy (21% NBF vs. 7% BF, OR = 3.44, 95% CI: 1.12-10.71), with modified World Health Organization (WHO) classification ≥III (33 vs. 14%, OR = 3.16, 95% CI: 1.22-8.15), and with prepregnancy ejection fraction (EF) < 50% (55 vs. 14%, OR = 7.20, 95% CI: 1.92-27.06). There were otherwise no differences between the two groups with regards to other cardiac diagnoses or cardiac risk scores. CONCLUSION: In women with MCD, cardiomyopathy, modified WHO class ≥III, and a prepregnancy EF < 50% were associated with NBF in the immediate postpartum period. These findings may guide providers in identifying a subset of women with MCD who can benefit from increased breastfeeding counseling and support. KEY POINTS: · Eighty-two percent of patients with cardiac disease are breastfeeding at the time of postpartum discharge.. · Cardiomyopathy is associated with an increased odds of not breastfeeding at postpartum discharge.. · Rationale for not breastfeeding is infrequently documented in the medical record..

Antiretroviral Regimen and Pregnancy Outcomes of Women Living with HIV in a US Cohort.

Women who are pregnant and living with HIV have traditionally been excluded from clinical trials regarding new pharmacotherapy. Immediate initiation of antiretroviral therapy (ART) is recommended for women who are pregnant and living with HIV. Integrase inhibitors (INSTIs) are first-line recommended agents as they lead to more rapid HIV viral load reduction. We conducted a retrospective study of women who are pregnant and living with HIV who received prenatal care at the University of Washington. Mothers were categorized by ART class: INSTI, protease inhibitors (PI), and non-nucleoside reverse transcriptase inhibitors (NNRTI). Chi-square and t-tests were used for the analysis of baseline characteristics, and generalized estimating equations were used to adjust for HIV viral suppression between groups. There were a total of 234 mother-infant pairs whose pregnancies progressed beyond 20 weeks. The study demonstrated that women on INSTI regimens were more likely to have a shorter time to viral load suppression than women on NNRTI regimens. Additionally, seven congenital anomalies were identified in this cohort, none of which were neural tube defects. There was no perinatal transmission of HIV to any of the infants. This small cohort of women provides high-quality data regarding the safety and efficacy of INSTI use for both mothers and infants in resource-rich settings.

Universal Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Testing for Obstetric Inpatient Units Across the United States.

BACKGROUND: The purpose of this study was to estimate prevalence of asymptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection among patients admitted to obstetric inpatient units throughout the United States as detected by universal screening. We sought to describe the relationship between obstetric inpatient asymptomatic infection rates and publicly available surrounding community infection rates. METHODS: A cross-sectional study in which medical centers reported rates of positive SARS-CoV-2 testing in asymptomatic pregnant and immediate postpartum patients over a 1-3-month time span in 2020. Publicly reported SARS-CoV-2 case rates from the relevant county and state for each center were collected from the COVID Act Now dashboard and the COVID Tracking Project for correlation analysis. RESULTS: Data were collected from 9 health centers, encompassing 18 hospitals. Participating health centers were located in Alabama, California, Illinois, Louisiana, New Jersey, North Carolina, Pennsylvania, Rhode Island, Utah, and Washington State. Each hospital had an active policy for universal SARS-CoV-2 testing on obstetric inpatient units. A total of 10 147 SARS-CoV-2 tests were administered, of which 124 were positive (1.2%). Positivity rates varied by site, ranging from 0-3.2%. While SARS-CoV-2 infection rates were lower in asymptomatic obstetric inpatient groups than the surrounding communities, there was a positive correlation between positivity rates in obstetric inpatient units and their surrounding county (P=.003, r=.782) and state (P=.007, r=.708). CONCLUSIONS: Given the correlation between community and obstetric inpatient rates, the necessity of SARS-CoV-2-related healthcare resource utilization in obstetric inpatient units may be best informed by surrounding community infection rates.

Survey of intrauterine red blood cell (RBC) transfusion practices in the United States.

BACKGROUND: A paucity of data exists about the current practice of fetal red blood cell (RBC) transfusion in the United States (US). This investigation describes intrauterine transfusion (IUT) RBC product selection and processing practices at different US institutions. METHODS: A transfusion medicine and maternal-fetal medicine (MFM) team designed a survey to interrogate and characterize RBCs utilized for IUT. This survey was distributed to seventy US institutions with fetal treatment centers (October 2020-April 2021) identified through the NAFTNet (North American Fetal Therapy Network). RESULTS: Thirty-seven institutions responded (response rate 53%, 37/70), but five were excluded for not performing IUTs. Most (84%; 27/32) performed 1-24 IUTs annually; two performed >50 IUTs/year. Group O, Rh(D) negative RBC units were always used by 66% (21/32), and 75% (24/32) provided hemoconcentrated RBCs by washing (17/24) or dry packing (6/24). Overall, 66% (21/32) targeted a hematocrit ≥75%. Fifty percent provided both leukocyte-reduced and CMV-negative RBC units. Irradiation of RBC units was performed within 6 h of issue at 63% (20/32) of sites. Most (81%, 26/32) used RBC units at <7 days of age after collection, 56% (18/32) always provided washed RBC units, while 19% (6/32) issued washed RBC only if fresh units are unavailable. Implicated maternal RBC alloantibodies were matched for 78% (25/32) of the time. The transfused volume was universally determined by the MFMs. DISCUSSION: Heterogeneity and lack of standardization exist in RBC product selection and special processing steps for IUTs in the US. Hence, the establishment of a consensus to standardize IUT protocols is needed.

Trends and outcomes for deliveries with hypertensive disorders of pregnancy from 2000 to 2018: A repeated cross-sectional study.

OBJECTIVE: To analyse trends, risk factors, and outcomes related to hypertensive disorders of pregnancy (HDP). DESIGN: Repeated cross-sectional. SETTING: US delivery hospitalisations. POPULATION: Delivery hospitalisations in the 2000-2018 National Inpatient Sample. METHODS: US hospital delivery hospitalisations with HDP were analysed. Several trends were analysed: (i) the proportion of deliveries by year with HDP, (ii) the proportion of deliveries with HDP risk factors and (iii) adverse outcomes associated with HDP including maternal stroke, acute renal failure and acute liver injury. Risk ratios were determined using regression models with HDP as the exposure of interest. MAIN OUTCOME MEASURES: Prevalence of HDP, risk factors for HDP and associated adverse outcomes. RESULTS: Of 73.1 million delivery hospitalisations, 7.7% had an associated diagnosis of HDP. Over the study period, HDP doubled from 6.0% of deliveries in 2000 to 12.0% in 2018. The proportion of deliveries with risk factors for HDP increased from 9.6% in 2000 to 24.6% in 2018. In adjusted models, HDP were associated with increased stroke (aRR [adjusted risk ratio] 15.9, 95% CI 14.8-17.1), acute renal failure (aRR 13.8, 95% CI 13.5-14.2) and acute liver injury (aRR 1.2, 95% CI 1.2-1.3). Among deliveries with HDP, acute renal failure and acute liver injury increased; in comparison, stroke decreased. CONCLUSION: Hypertensive disorders of pregnancy increased in the setting of risk factors for HDP becoming more common, whereas stroke decreased. TWEETABLE ABSTRACT: While hypertensive disorders of pregnancy increased from 2000 to 2018, stroke appears to be decreasing.

Middle Cerebral Artery Dopplers and Abnormal Neonatal Outcomes among Pregnant Women with Zika Virus Infection.

OBJECTIVE: The aim of this study was to investigate the role of middle cerebral artery (MCA) Doppler measurements for the prediction of abnormal neonatal outcomes in pregnancies affected by Zika virus (ZIKV). METHODS: Secondary analysis of a prospective cohort of pregnant women diagnosed with ZIKV infection from September 2015 to December 2016 at a single regional referral center. Ultrasonography with measurements of MCA peak systolic velocity (PSV), PSV multiples of the median (MoM) for gestational age, and pulsatility index (PI) were collected. The primary outcome was a composite abnormal neonatal outcome. MCA Doppler values of normal and abnormal neonatal outcomes were compared with Wilcoxon rank sum test. The predictive value of MCA Dopplers for development of abnormal neonatal outcome was calculated by logistic regression. RESULTS: One-hundred twenty-seven ZIKV-positive pregnancies with MCA Doppler measurements and known neonatal outcomes were included. Of the 132 neonates, 66 (50%) had an abnormal neonatal outcome. Lower MCA PSV (p = 0.027) and PSV MoM (p = 0.008) were associated with abnormal neonatal outcomes. There was no significant difference in MCA PI. Abnormal neonatal outcomes had lower MCA PSV by 5.36 cm/s (95% confidence interval [CI]: 0.95-9.77, p = 0.018) and lower MCA PSV MoM by 0.13 (95% CI: 0.05-0.22, p = 0.002). MCA PSV of 30 cm/s had a 65% predicted probability of an abnormal neonatal outcome (95% CI: 51-79%). CONCLUSION: In ZIKV-infected pregnancies, lower MCA PSV and PSV MoM measurements were seen with abnormal neonatal outcomes. This may represent a physiologic response to fetal ZIKV infection. Evaluation of MCA Dopplers may be of clinical utility in the surveillance of ZIKV-affected pregnancies. KEY POINTS: · Significantly lower MCA PSV is associated with abnormal neonatal outcomes in ZIKV pregnancies.. · Lower MCA PSV may reflect the underlying neuropathology of ZIKV exposure on the fetus.. · There is potential utility for MCA Doppler evaluation in antepartum surveillance of ZIKV pregnancies..

Outcomes of Monochorionic, Diamniotic Twin Pregnancies with Prenatally Diagnosed Intertwin Weight Discordance.

OBJECTIVE: Monochorionic, diamniotic (MCDA) twin pairs are predisposed to various pregnancy complications due to the unique placental angioarchitecture of monochorionicity. Few studies have evaluated the outcomes of weight-discordant MCDA pairs without selective fetal growth restriction (SFGR) or the risk factors for development of SFGR. This study aims to describe the natural history of expectant, noninvasive management of weight-discordant MCDA twins and to evaluate risk factors associated with progression to SFGR. STUDY DESIGN: This was a retrospective cohort study at a single, tertiary care center in the United States. All MCDA twins with isolated intertwin weight discordance (ITWD) ≥ 20% diagnosed before 26 weeks' gestational age (GA) were included. The primary outcome of descriptive analyses was overall pregnancy outcome, incorporating both survival to delivery and GA at delivery, as defined by the North American Fetal Therapy Network. The secondary outcome was SFGR in one twin (defined as estimated fetal weight < 10% for GA) and factors associated with this progression. Only those with fetal ultrasound (US) within 4 weeks of delivery were included in this secondary analysis. RESULTS: Among 73 MCDA pairs with ITWD, 73% had a good pregnancy outcome, with dual live delivery at a median GA of 33 weeks. Among the 34 pairs with adequate US follow-up, 56% developed SFGR. There were no differences in GA at delivery or discordance at birth between those who did and those who did not develop SFGR. There was a nonsignificant association between increasing ITWD at diagnosis and subsequent development of SFGR. CONCLUSION: Expectant, noninvasive management can be considered in MCDA twin pregnancies with ITWD ≥ 20% diagnosed before 26 weeks. This approach is associated with a good pregnancy outcome in the majority of cases, even after the development of SFGR in the smaller twin. KEY POINTS: · Nearly 75% of weight-discordant mo/di twins have a good pregnancy outcome.. · Weight-discordant mo/di twins deliver at a mean gestational age of 33 weeks without invasive therapy.. · Noninvasive management should be considered for weight-discordant mo/di twins..

Discordant Zika Virus Findings in Twin Pregnancies Complicated by Antenatal Zika Virus Exposure: A Prospective Cohort.

BACKGROUND: There are limited data on the natural history of antenatal Zika virus (ZIKV) exposure in twin pregnancies, especially regarding intertwin concordance of prenatal, placental, and infant outcomes. METHODS: This prospective cohort study included twin pregnancies referred to a single institution from September 2015 to June 2016 with maternal ZIKV. Polymerase chain reaction (PCR) testing of maternal, placental, and neonatal samples was performed. Prenatal ultrasounds were completed for each twin, and histomorphologic analysis was performed for each placenta. Abnormal neonatal outcome was defined as abnormal exam and/or abnormal imaging. Two- to three-year follow-up of infants included physical exams, neuroimaging, and Bayley-III developmental assessment. RESULTS: Among 244 pregnancies, 4 twin gestations without coinfection were identified. Zika virus infection occurred at 16-33 weeks gestation. Zika virus PCR testing revealed discordance between dichorionic twins, between placentas in a dichorionic pair, between portions of a monochorionic placenta, and between a neonate and its associated placenta. Of the 8 infants, 3 (38%) had an abnormal neonatal outcome. Of 6 infants with long-term follow-up, 3 (50%) have demonstrated ZIKV-related abnormalities. CONCLUSIONS: Neonatal PCR testing, placental findings, and infant outcomes can be discordant between co-twins with antenatal ZIKV exposure. These findings demonstrate that each twin should be evaluated independently for vertical transmission.

Readmission Rates After Expedited Postpartum Discharge.

OBJECTIVE: To characterize national trends in expedited postpartum discharge and, secondarily, to identify predictors of expedited postpartum discharge and assess whether expedited postpartum discharge was associated with postpartum readmissions within 60 days of delivery hospitalization discharge. METHODS: Birth hospitalizations and subsequent 60-day postpartum readmissions were extracted from the 2016-2020 Nationwide Readmissions Database for this retrospective cohort study. Postpartum discharge was categorized as expedited (less than 2 days after vaginal birth or less than 3 days after cesarean birth), routine (2 days after vaginal birth or 3 days after cesarean birth), or prolonged (more than 2 days after vaginal birth or more than 3 days after cesarean birth). Trends in expedited discharge were assessed over the study period with joinpoint regression. Unadjusted and adjusted logistic regression models were performed to assess clinical, hospital, and demographic predictors of expedited postpartum discharge. Sixty-day postpartum readmission risk was calculated, and adjusted regression models were performed to evaluate the association between expedited postpartum discharge and readmission. RESULTS: Of 17.9 million birth hospitalizations, 32.9% had expedited postpartum discharge. The overall 60-day postpartum readmission rate after delivery hospitalization discharge was 1.7% for all patients, 1.4% for expedited postpartum discharge, 1.6% for routine discharge, and 3.3% for prolonged discharge. Rates of expedited postpartum increased from 29.1% in 2016 to 31.4% in 2019 and to 43.8% in 2020. This trend was not significant (average annual percent change: 9.9%, 95% CI, -1.6% to 23.7%), although rates of expedited discharge were significantly higher in 2020 than in 2016-2019 ( P <.01). Younger and older age, chronic comorbid conditions, mental health conditions, and obstetric complications (eg, transfusion, chorioamnionitis or endometritis) were associated with lower likelihood of expedited postpartum discharge. Expedited postpartum discharge was associated with 14% lower adjusted odds of 60-day postpartum readmission compared with routine discharge (adjusted odds ratio 0.86, 95% CI, 0.85-0.88). CONCLUSION: Rates of expedited postpartum discharge increased significantly in 2020 compared with 2016-2019 and were not associated with 60-day postpartum readmission. These findings suggest that broader use of expedited postpartum discharge has not resulted in increased risk of postpartum readmissions.

Health Service Use and Costs During Pregnancy Among Privately Insured Individuals With Congenital Heart Disease.

Importance: Individuals with congenital heart disease (CHD) are increasingly reaching childbearing age, are more prone to adverse pregnancy events, and uncommonly undergo recommended cardiac evaluations. Data to better understand resource allocation and financial planning are lacking. Objective: To examine health care use and costs for patients with CHD during pregnancy. Design, Setting, and Participants: This retrospective cohort study was performed from January 1, 2010, to December 31, 2016, using Merative MarketScan commercial insurance data. Participants included patients with CHD and those without CHD matched 1:1 by age, sex, and insurance enrollment year. Pregnancy claims were identified for all participants. Data were analyzed from September 2022 to March 2024. Exposures: Baseline characteristics (age, US region, delivery year, insurance type) and pregnancy-related events (obstetric, cardiac, and noncardiac conditions; birth outcomes; and cesarean delivery). Main Outcomes and Measures: Health service use (outpatient physician, nonphysician, emergency department, prescription drugs, and admissions) and costs (total and out-of-pocket costs adjusted for inflation to represent 2024 US dollars). Results: A total of 11 703 pregnancies (mean [SD] maternal age, 31.5 [5.4] years) were studied, with 2267 pregnancies in 1785 patients with CHD (492 pregnancies in patients with severe CHD and 1775 in patients with nonsevere CHD) and 9436 pregnancies in 7720 patients without CHD. Compared with patients without CHD, pregnancies in patients with CHD were associated with significantly higher health care use (standardized mean difference [SMD] range, 0.16-1.46) and cost (SMD range, 0.14-0.55) except for out-of-pocket inpatient and ED costs. After adjustment for covariates, having CHD was independently associated with higher total (adjusted cost ratio, 1.70; 95% CI, 1.57-1.84) and out-of-pocket (adjusted cost ratio, 1.40; 95% CI, 1.22-1.58) costs. The adjusted mean total costs per pregnancy were $15 971 (95% CI, $15 480-$16 461) for patients without CHD, $24 290 (95% CI, $22 773-$25 806) for patients with any CHD, $26 308 (95% CI, $22 788-$29 828) for patients with severe CHD, and $23 750 (95% CI, $22 110-$25 390) for patients with nonsevere CHD. Patients with vs without CHD incurred $8319 and $700 higher total and out-of-pocket costs per pregnancy, respectively. Conclusions and Relevance: This study provides novel, clinically relevant estimates for the cardio-obstetric team, patients with CHD, payers, and policymakers regarding health care and financial planning. These estimates can be used to carefully plan for and advocate for the comprehensive resources needed to care for patients with CHD.

Viewpoint: Challenges and strategies for engaging participants in videoconferencing appointments.

There are unique challenges that arise from participating in remote clinical trials. Broadly, findings suggest that participants enrolled in digital intervention trials are more likely to disengage or prematurely dropout than participants in face-to-face trials. Thus, optimizing contact with participants via video-conferencing platforms to build rapport and encourage commitment to the study is critical. Still, challenges with video-conferencing visits can pose challenges. Some of these challenges include a lack of clarity about study requirements, difficulties demonstrating staff engagement and building rapport, and the technical challenges of using video-conferencing software. These challenges can affect participant retention, study validity, and the willingness of underserved groups to participate in research. In the context of a remote randomized clinical trial evaluating a digital intervention for prenatal insomnia, we discuss strategies used to counteract these challenges, including the use of virtual orientation sessions, and practical recommendations to improve staff engagement with participants. These findings are relevant to research teams conducting remote clinical trials, especially those seeking to recruit and retain participants from populations currently and historically underrepresented in research.

Diabetic Ketoacidosis and Adverse Outcomes Among Pregnant Individuals With Pregestational Diabetes in the United States, 2010-2020.

OBJECTIVE: To assess the frequency of, risk factors for, and adverse outcomes associated with diabetic ketoacidosis (DKA) at delivery hospitalization among individuals with pregestational diabetes (type 1 and 2 diabetes mellitus) and secondarily to evaluate the frequency of and risk factors for antepartum and postpartum hospitalizations for DKA. METHODS: We conducted a serial, cross-sectional study using the Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project Nationwide Readmissions Database from 2010 to 2020 of pregnant individuals with pregestational diabetes hospitalized for delivery. The exposures were 1) sociodemographic and clinical risk factors for DKA and 2) DKA. The outcomes were DKA at delivery hospitalization, maternal morbidity (nontransfusion severe maternal morbidity (SMM), critical care procedures, cardiac complications, acute renal failure, and transfusion), and adverse pregnancy outcomes (preterm birth, hypertensive disorders of pregnancy, and cesarean delivery) and secondarily DKA at antepartum and postpartum hospitalizations. RESULTS: Of 392,796 deliveries in individuals with pregestational diabetes (27.2% type 1 diabetes, 72.8% type 2 diabetes), there were 4,778 cases of DKA at delivery hospitalization (89.1% type 1 diabetes, 10.9% type 2 diabetes). The frequency of DKA at delivery hospitalization was 1.2% (4.0% with type 1 diabetes, 0.2% with type 2 diabetes), and the mean annual percentage change was 10.8% (95% CI, 8.2-13.2%). Diabetic ketoacidosis at delivery hospitalization was significantly more likely among those who had type 1 diabetes compared with those with type 2 diabetes, who were younger in age, who delivered at larger and metropolitan hospitals, and who had Medicaid insurance, lower income, multiple gestations, and prior psychiatric illness. Diabetic ketoacidosis during the delivery hospitalization was associated with an increased risk of nontransfusion SMM (20.8% vs 2.4%, adjusted odds ratio [aOR] 8.18, 95% CI, 7.20-9.29), critical care procedures (7.3% vs 0.4%, aOR 15.83, 95% CI, 12.59-19.90), cardiac complications (7.8% vs 0.8%, aOR 8.87, 95% CI, 7.32-10.76), acute renal failure (12.3% vs 0.7%, aOR 9.78, 95% CI, 8.16-11.72), and transfusion (6.2% vs 2.2%, aOR 2.27, 95% CI, 1.87-2.75), as well as preterm birth (31.9% vs 13.5%, aOR 2.41, 95% CI, 2.17-2.69) and hypertensive disorders of pregnancy (37.4% vs 28.1%, aOR 1.11, 95% CI, 1.00-1.23). In secondary analyses, the overall frequency of antepartum DKA was 3.1%, and the mean annual percentage change was 4.1% (95% CI, 0.3-8.6%); the overall frequency of postpartum DKA was 0.4%, and the mean annual percentage change was 3.5% (95% CI, -1.6% to 9.6%). Of 3,092 antepartum hospitalizations among individuals with DKA, 15.7% (n=485) had a recurrent case of DKA at delivery hospitalization. Of 1,419 postpartum hospitalizations among individuals with DKA, 20.0% (n=285) previously had DKA at delivery hospitalization. The above risk factors for DKA at delivery hospitalization were similar for DKA at antepartum and postpartum hospitalizations. CONCLUSION: The frequency of DKA at delivery hospitalization and antepartum hospitalizations for DKA increased between 2010 and 2020 among deliveries in individuals with pregestational diabetes in the United States. Diabetic ketoacidosis is associated with an increased risk of maternal morbidity and adverse pregnancy outcomes. Risk factors for DKA at delivery were similar to those for DKA during the antepartum and postpartum periods.

Roadmap to safety: a single center study of evidence-informed approach to placenta accreta spectrum.

Objective: To assess the impact of an evidence-informed protocol for management of placenta accreta spectrum (PAS). Methods: This was a retrospective cohort study of patients who underwent cesarean hysterectomy (c-hyst) for suspected PAS from 2012 to 2022 at a single tertiary care center. Perioperative outcomes were compared pre- and post-implementation of a standardized Multidisciplinary Approach to the Placenta Service (MAPS) protocol, which incorporates evidence-informed perioperative interventions including preoperative imaging and group case review. Intraoperatively, the MAPS protocol includes placement of ureteral stents, possible placental mapping with ultrasound, and uterine artery embolization by interventional radiology. Patients suspected to have PAS on prenatal imaging who underwent c-hyst were included in the analysis. Primary outcomes were intraoperative complications and postoperative complications. Secondary outcomes were blood loss, need for ICU, and length of stay. Proportions were compared using Fisher's exact test, and continuous variables were compared used t-tests and Mood's Median test. Results: There were no differences in baseline demographics between the pre- (n = 38) and post-MAPS (n = 34) groups. The pre-MAPS group had more placenta previa (95% pre- vs. 74% post-MAPS, p = 0.013) and prior cesarean sections (2 prior pre- vs. 1 prior post-MAPS, p = 0.012). The post-MAPS group had more severe pathology (PAS Grade 3 8% pre- vs. 47% post-MAPS, p = 0.001). There were fewer intraoperative complications (39% pre- vs.3% post-MAPS, p < 0.001), postoperative complications (32% pre- vs.12% post-MAPS, p = 0.043), hemorrhages >1l (95% pre- vs.65% post-MAPS, p = 0.001), ICU admissions (59% pre- vs.35% post-MAPS, p = 0.04) and shorter hospital stays (10 days pre- vs.7 days post-MAPS, p = 0.02) in the post-MAPS compared to pre-MAPS patients. Neonatal length of stay was 8 days longer in the post-MAPS group (9 days pre- vs. 17 days post-MAPS, p = 0.03). Subgroup analyses demonstrated that ureteral stent placement and uterine artery embolization (UAE) may be important steps to reduce complications and ICU admissions. When comparing just those who underwent UAE, patients in the post-MAPS group experienced fewer hemorrhages greater five liters (EBL >5l 43% pre- vs.4% post-MAPS, p = 0.007). Conclusion: An evidence-informed approach to management of PAS was associated with decreased complication rate, EBL >1l, ICU admission and length of hospitalization, particularly for patients with severe pathology.

Comparative effectiveness trial of metformin versus insulin for the treatment of gestational diabetes in the USA: clinical trial protocol for the multicentre DECIDE study.

INTRODUCTION: Gestational diabetes mellitus (GDM) is one of the most common medical complications of pregnancy. Glycaemic control decreases the risk of adverse pregnancy outcomes for the affected pregnant individual and the infant exposed in utero. One in four individuals with GDM will require pharmacotherapy to achieve glycaemic control. Injectable insulin has been the mainstay of pharmacotherapy. Oral metformin is an alternative option increasingly used in clinical practice. Both insulin and metformin reduce the risk of adverse pregnancy outcomes, but comparative effectiveness data from a well-characterised, adequately powered study of a diverse US population remain lacking. Because metformin crosses the placenta, long-term safety data, in particular, the risk of childhood obesity, from exposed children are also needed. In addition, the patient-reported experiences of individuals with GDM requiring pharmacotherapy remain to be characterised, including barriers to and facilitators of metformin versus insulin use. METHODS AND ANALYSIS: In a two-arm open-label, pragmatic comparative effectiveness randomised controlled trial, we will determine if metformin is not inferior to insulin in reducing adverse pregnancy outcomes, is comparably safe for exposed individuals and children, and if patient-reported factors, including facilitators of and barriers to use, differ between metformin and insulin. We plan to recruit 1572 pregnant individuals with GDM who need pharmacotherapy at 20 US sites using consistent diagnostic and treatment criteria for oral metformin versus injectable insulin and follow them and their children through delivery to 2 years post partum. More information is available at www.decidestudy.org. ETHICS AND DISSEMINATION: The Institutional Review Board at The Ohio State University approved this study (IRB: 2024H0193; date: 7 December 2024). We plan to submit manuscripts describing the results of each study aim, including the pregnancy outcomes, the 2-year follow-up outcomes, and mixed-methods assessment of patient experiences for publication in peer-reviewed journals and presentations at international scientific meetings. TRIAL REGISTRATION NUMBER: NCT06445946.

Mode of delivery and neonatal outcomes with early preterm severe preeclampsia: does fetal growth restriction matter?

OBJECTIVE: Severe preeclampsia diagnosed at or prior to 34 weeks is an indication for preterm delivery. Many patients with severe preeclampsia develop fetal growth restriction as a result of the placental dysfunction associated with both conditions. The ideal mode of delivery in cases of preterm severe preeclampsia with fetal growth restriction remains controversial, with providers often proceeding directly to cesarean delivery rather than attempting a trial of labor due to theoretic concerns about the harms of labor in the face of placental dysfunction. There are limited data supporting this approach. This study evaluates whether the presence of fetal growth restriction affects the ultimate mode of delivery or neonatal outcomes among pregnancies with severe preeclampsia undergoing induction of labor at or before 34 weeks. METHODS: This was a retrospective cohort study of singletons with severe preeclampsia undergoing induction of labor ≤ 34 weeks at a single center between January 2015 and April 2022. The primary predictor was fetal growth restriction, defined as estimated fetal weight < 10th percentile for gestational age on ultrasound. Mode of delivery and neonatal outcomes were compared between those with and without fetal growth restriction using Fisher's exact and Kruskal-Wallis tests, and multivariate logistic regression was used to obtain adjusted odds ratios. RESULTS: 159 patients were included (N = 117 without fetal growth restriction, N = 42 with fetal growth restriction). There was no difference in vaginal delivery between the groups (70% vs 67%, p = .70). While those with fetal growth restriction had a higher incidence of respiratory distress syndrome and longer neonatal hospital stay, these differences were not statistically significant after adjusting for gestational age at delivery. There were no significant differences in other neonatal outcomes, including Apgar score, cord blood gases, intraventricular hemorrhage, necrotizing enterocolitis, neonatal sepsis, and neonatal demise. CONCLUSION: For pregnancies complicated by severe preeclampsia that require delivery ≤ 34 weeks, the likelihood of successful vaginal delivery following induction of labor does not differ based on presence of fetal growth restriction. Furthermore, fetal growth restriction is not an independent risk factor for adverse neonatal outcomes in this population. Induction of labor should be considered a reasonable approach and should be routinely offered to patients with concurrent preterm severe preeclampsia and fetal growth restriction.

Postpartum Hemorrhage Trends and Outcomes in the United States, 2000-2019.

OBJECTIVE: To analyze temporal trends in and risk factors for postpartum hemorrhage and to analyze the association of risk factors with postpartum hemorrhage-related interventions such as blood transfusion and peripartum hysterectomy. METHODS: This repeated cross-sectional study analyzed delivery hospitalizations from 2000 to 2019 in the National (Nationwide) Inpatient Sample. Trends analyses were conducted using joinpoint regression to estimate the average annual percent change (AAPC) with 95% CIs. Unadjusted and adjusted survey-weighted logistic regression models were performed to evaluate the relationship between postpartum hemorrhage risk factors and likelihood of 1) postpartum hemorrhage, 2) postpartum hemorrhage that requires blood transfusion, and 3) peripartum hysterectomy in the setting of postpartum hemorrhage, with unadjusted odds ratios and adjusted odds ratios with 95% CIs as measures of association. RESULTS: Of an estimated 76.7 million delivery hospitalizations, 2.3 million (3.0%) were complicated by postpartum hemorrhage. From 2000 to 2019, the rate of postpartum hemorrhage increased from 2.7% to 4.3% (AAPC 2.6%, 94% CI 1.7-3.5%). Over the study period, the proportion of deliveries to individuals with at least one postpartum hemorrhage risk factor increased from 18.6% to 26.9% (AAPC 1.9%, 95% CI 1.7-2.0%). Among deliveries complicated by postpartum hemorrhage, blood transfusions increased from 5.4% to 16.7% from 2000 to 2011 and then decreased from 16.7% to 12.6% from 2011 to 2019. Peripartum hysterectomy among hospitalized individuals with postpartum hemorrhage increased from 1.4% to 2.4% from 2000 to 2009, did not change significantly from 2009 to 2016, and then decreased significantly from 2.1% to 0.9% from 2016 to 2019 (AAPC -27.0%, 95% CI -35.2% to -17.6%). Risk factors associated with postpartum hemorrhage and transfusion and hysterectomy in the setting of postpartum hemorrhage included prior cesarean delivery with previa or placenta accreta, placenta previa without prior cesarean delivery, and antepartum hemorrhage or placental abruption. CONCLUSION: Postpartum hemorrhage and related risk factors increased over a 20-year period. Despite the increased postpartum hemorrhage rates, blood transfusions, and hysterectomy rates decreased in recent years.

Validated Calculators Predicting Cesarean Delivery After Induction: Accuracy in an External Population.

OBJECTIVE: To evaluate the performance of two previously published calculators in predicting cesarean delivery after induction of labor in an external population. METHODS: This was a cohort study including all nulliparous pregnant patients with singleton, term, vertex fetuses; intact membranes; and unfavorable cervices who underwent induction of labor between 2015 and 2017 at an academic tertiary care institution. Individual predicted cesarean risk scores were calculated with two previously published calculators. For each calculator, patients were stratified into three risk groups (lower, middle, and upper thirds) of approximately equivalent size. Predicted and observed incidences of cesarean delivery were compared with two-tailed binomial tests of probability in the overall population and in each risk group. RESULTS: A total of 846 patients met inclusion criteria, and 262 (31.0%) had cesarean deliveries, which was significantly lower than overall predicted rates of 40.0% and 36.2% with the two calculators (both P <.01). Both calculators significantly overestimated risk of cesarean delivery in higher risk tertiles (all P <.05). The areas under the receiver operating characteristic for both calculators were 0.57 or less in the overall population and in each risk group, suggesting poor predictive value. Higher predicted risk tertile in both calculators was not associated with any maternal or neonatal outcomes except wound infection. CONCLUSION: Both previously published calculators had poor performance in this population, with neither calculator accurately predicting the incidence of cesarean delivery. Patients and health care professionals might be discouraged regarding trial of labor induction by falsely high predicted risk-of-cesarean scores. We caution against widespread implementation of these calculators without further population-specific refinement and adjustment.

Contraceptive counseling and choices in pregnancies with maternal cardiac disease.

OBJECTIVE: Unplanned pregnancies in women with maternal cardiac disease (MCD) are associated with increased morbidity and mortality, but the majority of these individuals do not use highly reliable contraception on postpartum hospital discharge. Contraceptive counseling in this population outside of pregnancy is incomplete and counseling during pregnancy remains poorly characterized. Our objective was to evaluate the provision and quality of contraceptive counseling for individuals with MCD during pregnancy. METHODS: All individuals with MCD who delivered between 2008 and 2021 at a tertiary care institution with a multidisciplinary cardio-obstetrics team were sent a 27-question survey. A subset of questions were derived from the validated Interpersonal Quality in Family Planning (IQFP) survey, which emphasizes interpersonal connection, adequate information, and decision support for the individual. Each participant received a $15 gift card for survey completion. We performed chart review for clinical and demographic details, including cardiac risk score. RESULTS: Of 522 individuals to whom the survey was sent, 133 responded and met inclusion criteria. Overall, 67% discussed contraception with their general obstetrician, 36% with their maternal-fetal medicine (MFM) specialist, and 24% with their cardiologist. Compared to individuals with low cardiac risk scores, those with high cardiac risk scores had a nonsignificant trend toward being more likely to discuss contraception with a MFM provider (52% vs 33%, p = .08). 65% reported that their provider was 'excellent' or 'good' in all IQFP domains. Respondents valued providers who respected their autonomy and offered thorough counseling. Respondents disliked feeling pressured or uninformed about the safety of contraceptive options. CONCLUSION: Most individuals with MCD reported excellent contraceptive counseling during pregnancy. Additional work is needed to understand barriers to and enablers for effective, patient-centered contraceptive counseling and use in this population.

Delivery trends and obstetric outcomes in patients with Fontan circulation.

BACKGROUND: With improved therapies, an increasing number of patients with Fontan circulation reach reproductive age. Pregnant patients with Fontan circulation are at high risk of obstetrical complications. Most data for pregnancies complicated by Fontan circulation and associated complications stem from single-center studies, with limited national epidemiologic data available. OBJECTIVE: This study aimed to evaluate temporal trends in deliveries to pregnant individuals with Fontan palliation using nationwide data and to estimate associated obstetrical complications among these deliveries. STUDY DESIGN: Delivery hospitalizations were abstracted from the 2000 to 2018 Nationwide Inpatient Sample. Deliveries complicated by Fontan circulation were identified using diagnosis codes, and trends in the rates of these deliveries were assessed using joinpoint regression. Baseline demographics and obstetrical outcomes (including severe maternal morbidity, a composite of serious obstetrical and cardiac complications) were assessed. Univariable log-linear regression models were fit comparing risks of outcomes among deliveries of patients with and without Fontan circulation. RESULTS: A total of 509 pregnancies complicated by Fontan circulation were identified at a rate of 7 per 1 million delivery hospitalizations, with a temporal increase from 2.4 to 30.3 cases per 1 million from 2000 to 2018 (P<.01). Deliveries complicated by Fontan circulation were at higher risk of hypertensive disorders (relative risk, 1.79; 95% confidence interval, 1.42-2.27), preterm delivery (relative risk, 2.37; 95% confidence interval, 1.90-2.96), postpartum hemorrhage (relative risk, 4.28; 95% confidence interval, 3.35-5.45), and severe maternal morbidity (relative risk, 6.09; 95% confidence interval, 4.54-8.17) than deliveries not complicated by Fontan circulation. CONCLUSION: The rates of deliveries of patients with Fontan palliation are increasing on a national level. These deliveries have higher risks of obstetrical complications and severe maternal morbidity. Additional national clinical data are necessary to better understand the complications in pregnancies complicated by Fontan circulation, to improve patient counseling, and to reduce maternal morbidity.