A More Selective vs a Standard Risk-Stratified, Heparin-Based, Obstetric Thromboprophylaxis Protocol.

Importance: In 2016, our institution adopted a pregnancy-related venous thromboembolism (VTE) prophylaxis protocol based on American College of Obstetricians and Gynecologists guidelines that recommended postpartum heparin-based chemoprophylaxis (enoxaparin) based on a risk-stratified algorithm. In response to increased wound hematomas without significant reduction in VTE using this protocol, a more selective risk-stratified approach was adopted in 2021. Objective: To evaluate outcomes of the more selective risk-stratified approach to heparin-based obstetric thromboprophylaxis (enoxaparin) protocol. Design, Setting, and Participants: Retrospective observational study of 17 489 patients who delivered at a single tertiary care center in the southeast US between January 1, 2016, and December 31, 2018 (original protocol), and between December 1, 2021, and May 31, 2023 (more selective protocol). Patients receiving outpatient anticoagulation for active VTE or high VTE risk during pregnancy were excluded. Exposure: Standard risk-stratified and more selective postpartum VTE chemoprophylaxis protocols. Main Outcomes and Measures: The primary outcome was clinical diagnosis of wound hematoma up to 6 weeks pos tpartum. The secondary outcome was new diagnosis of VTE up to 6 weeks post partum. We compared baseline characteristics and outcomes between groups and estimated adjusted odds ratios with 95% CIs of primary and secondary outcomes using the original protocol group as reference. Results: Of 17 489 patients included in the analysis, 12 430 (71%) were in the original protocol group and 5029 (29%) were in the more selective group. Rates of chemoprophylaxis decreased from 16% (original protocol) to 8% (more selective protocol). Patients in the more selective group were more likely to be older, be married, and have obesity or other comorbidities (hypertension, diabetes, cardiac disease). Compared with the original protocol, the more selective protocol was associated with a decrease in any wound hematoma (0.7% vs 0.3%; adjusted odds ratio [aOR], 0.38; 95% CI, 0.21-0.67), specifically due to a lower rate of superficial wound hematomas (0.6% vs 0.3%; aOR, 0.43; 95% CI, 0.24-0.75). There was no significant increase in VTE or individual types of VTE (0.1% vs 0.1%; aOR, 0.40; 95% CI, 0.12-1.36). Conclusions and Relevance: A more selective risk-stratified approach to an enoxaparin thromboprophylaxis protocol for VTE was associated with decreased rates of wound hematomas without increased rates of postpartum VTE.

Continuous Glucose Monitoring for Management of Type 2 Diabetes and Perinatal Outcomes.

OBJECTIVE: To evaluate the association between continuous glucose monitoring in pregnant people with type 2 diabetes and perinatal outcomes. METHODS: This was a retrospective cohort study of pregnant people with type 2 diabetes who received prenatal care and delivered singleton, nonanomalous neonates at a single academic tertiary care center from November 1, 2019, to February 28, 2023. The primary outcome was a composite of neonatal morbidity, including hypoglycemia, hyperbilirubinemia, shoulder dystocia, large for gestational age at birth, preterm birth, neonatal intensive care unit (NICU) admission, or perinatal death. Demographics and outcomes were compared by type of monitoring (continuous glucose monitoring vs intermittent self-monitoring of blood glucose), and multivariable logistic regression estimated the association between continuous glucose monitoring use and perinatal outcomes. RESULTS: Of 360 pregnant people who met the inclusion criteria, 82 (22.7%) used continuous glucose monitoring. The mean gestational age at continuous glucose monitoring initiation was 21.3±6.4 weeks. The use of continuous glucose monitoring was associated with lower odds of the primary composite neonatal morbidity (65.9% continuous glucose monitoring vs 77.0% self-monitoring of blood glucose, adjusted odds ratio [aOR] 0.48, 95% CI, 0.24-0.94). Continuous glucose monitoring use was also associated with lower odds of preterm birth (13.4% vs 25.2%, aOR 0.48, 95% CI, 0.25-0.93) and NICU admission (33.8% vs 47.6%, aOR 0.36, 95% CI, 0.16-0.81). CONCLUSION: In pregnant people with type 2 diabetes, continuous glucose monitoring use was associated with less neonatal morbidity, fewer preterm births, and fewer NICU admissions.

Reevaluating Associations between Prenatal Care Utilization and Current Trends in Preterm Birth.

OBJECTIVE: Studies have suggested an association between prenatal care (PNC) and preterm birth (PTB). We evaluated trends in PTB and association of PNC and PTB. STUDY DESIGN: This was a retrospective cohort study of singleton, viable nonanomalous deliveries from 1991 to 2018. PNC utilization was defined by World Health Organization using number of visits: adequate (≥8), suboptimal (5-7), and inadequate (<5). Primary outcome was PTB. Tests of trend were used to assess changes in PTB over time. Baseline characteristics and outcomes were compared. Logistic regression estimated the association of PNC and PTB. We evaluated for effect modification by year of birth. RESULTS: Of 92,294 patients, 14,057 (15%) had PTB. Inadequate and suboptimal PNC were associated with higher odds of PTB compared to adequate PNC (adjusted odds ratios [aOR 6.21], 95% confidence interval [CI] 5.84-6.60; aOR 3.57, 95% CI 3.36-3.79). Inadequate PNC was associated with higher odds of PTB over time (effect modification p < 0.0001). Inadequate PNC was associated with 5.4 times higher odds of PTB in 1998, 7.0 times in 2008, and 9.1 times in 2018. CONCLUSION: Despite an increase in adequate PNC, there was a rise in PTB associated with inadequate and suboptimal PNC. PNC utilization was a stronger risk factor in recent years with higher PTB in patients who attended more than five PNC visits. KEY POINTS: · PNC utilization is associated with the risk of PTB.. · Despite an increase in PNC utilization, PTB rates have increased.. · There is an even stronger association between PNC utilization and PTB over time..

Systematic Review of Lymphangioleiomyomatosis Outcomes in Pregnancy and a Proposed Management Guideline.

OBJECTIVE: Lymphangioleiomyomatosis (LAM) is a rare, multisystem disease that primarily affects women of reproductive age. Disease progression has been linked to estrogen exposure, and as such many patients are advised to avoid pregnancy. Data are limited regarding the interaction between LAM and pregnancy, and as such we performed a systematic review to summarize available literature reporting outcomes of pregnancies complicated by maternal LAM. STUDY DESIGN: This was a systematic review including randomized controlled trials, observational studies, systematic reviews, case reports, clinical practice guidelines, and quality improvement studies with full-text manuscripts or abstracts in the English language with primary data on pregnant or postpartum patients with LAM. The primary outcome was maternal outcomes during pregnancy as well as pregnancy outcomes. Secondary outcomes were neonatal outcomes and long-term maternal outcomes. This search occurred in July 2020 and included MEDLINE, Scopus, clinicaltrials.gov, Embase, and Cochrane Central. Risk of bias was ascertained using the Newcastle-Ottawa Scale. Our systematic review was registered with PROSPERO as protocol number CRD 42020191402. RESULTS: A total of 175 publications were identified in our initial search; ultimately 31 studies were included. Six (19%) studies were retrospective cohort studies and 25 (81%) studies were case reports. Patients diagnosed during pregnancy had worse pregnancy outcomes compared to those diagnosed with LAM prior to pregnancy. Multiple studies reported a significant risk of pneumothoraces during pregnancy. Other significant risks included preterm delivery, chylothoraces, and pulmonary function deterioration. A proposed strategy for preconception counseling and antenatal management is provided. CONCLUSION: Patients diagnosed with LAM during pregnancy generally experience worse outcomes including recurrent pneumothoraces and preterm delivery as compared to patients with a LAM diagnosis prior to pregnancy. Given that there are limited studies available, and that the majority are low-quality evidence and subject to bias, further investigation of the interaction between LAM and pregnancy is warranted to guide patient care and counseling. KEY POINTS: · Data are limited on the effects of lymphangioleiomyomatosis on pregnancy outcomes.. · We performed a systematic review to summarize pregnancy outcomes complicated by LAM.. · Patients diagnosed with LAM during pregnancy experience worse outcomes..

Baseline renal function and adverse outcomes in pregnancies complicated by pregestational diabetes.

OBJECTIVE: To examine the relationship between baseline renal function (serum creatinine, urine protein to creatinine ratio) in women with diabetes and adverse pregnancy outcomes. STUDY DESIGN: This was a retrospective cohort study of singleton pregnancies with pregestational diabetes and baseline renal function tests <20 weeks gestational age (wga) from the years 2007 to 2013. Those with baseline creatinine ≥1.2 mg/dL were excluded due to the association of renal disease with adverse outcomes. The primary outcome was the development of preeclampsia with severe features at <34 wga. Secondary outcomes were preeclampsia at any gestational age, preterm birth, indicated preterm birth, small for gestational age, and a neonatal adverse outcomes composite. The relationship between baseline renal function and the primary outcome was assessed with ROC curves. Objective cutoffs were determined by the Liu method. Outcomes were compared using univariable and multivariable analyses. RESULTS: Baseline renal function was assessed in 321 women with pregestational diabetes. With baseline serum creatinine <1.2 mg/dL serum creatinine was not associated with preeclampsia <34 weeks (AUC 0.47, 95% CI = 0.32-0.63). Urine protein to creatinine (UPC) ratio was moderately associated with preeclampsia <34 weeks with area under curve (AUC) 0.56 (0.39-0.74). Baseline creatinine above the Liu cutoff (0.65 mg/dL) was not significantly associated with primary or secondary outcomes (Table 1). UPC above the Liu cutoff (0.21) was significantly associated with severe preeclampsia <34 wga (24% vs 3.7%, aOR = 6.6, 95% CI = 2.1-20.8), with development of preeclampsia at any gestational age (56% vs 23.4%, aOR = 3.3, 95% CI = 1.4-7.9), and preterm birth (80% vs 36.2%, aOR 6.5 95% CI = 2.3-18.1). CONCLUSION: Creatinine was not associated with adverse pregnancy outcomes at thresholds <1.2 mg/dL in women with pregestational diabetes. Those with a baseline UPC ≥ 0.21 have an increased risk of preeclampsia and preterm delivery. Baseline 24 hr urine protein should be obtained in these patients to aid in counseling and future diagnosis of preeclampsia.Key PointsBaseline renal function tests are recommended in patients with pregestational diabetes, but values associated with pregnancy risk are poorly defined.This study evaluated the relationship between baseline renal function tests in patients with pregestational diabetes and adverse pregnancy outcomes.We found urine protein to creatinine ratio ≥0.21 to be associated with the development of severe preeclampsia <34 weeks gestational age as well as preeclampsia at any gestational age.

Early Gestational Diabetes Screening Based on ACOG Guidelines.

OBJECTIVE: A recent randomized controlled trial suggested that early gestational diabetes mellitus (GDM) screening in patients with obesity (body mass index [BMI] ≥30 kg/m2) does not improve perinatal outcomes. The American College of Obstetrics and Gynecology currently recommends early screening for gestational diabetes in patients who are overweight with one or more additional risk factors. We evaluated the effect of screening based on the number of additional risk factors for development of gestational diabetes. STUDY DESIGN: This was a secondary analysis of a multicenter randomized controlled trial of obese patients with singleton nonanomalous fetuses comparing early (14-20 weeks' gestation) with routine (24-28 weeks' gestation) GDM screening. Exclusion criteria were pregestational diabetes, major medical illnesses, bariatric surgery, chronic steroid use, and prior cesarean. Early versus routine GDM screening groups were compared and stratified by the number of additional risk factors for GDM (0, 1, 2, and ≥3). The primary outcome was an adverse perinatal composite outcome composed of: macrosomia, primary cesarean delivery, hypertensive disorders of pregnancy, shoulder dystocia, neonatal hyperbilirubinemia, and neonatal hypoglycemia. Analyses examined effects of early versus routine screening by the number of additional risk factors and their possible interaction on the incidences of the primary outcome and GDM. RESULTS: Of 913 patients, 5% had 0, 52% had 1, 33% had 2, and 10% had ≥3 additional risk factors. Baseline characteristics, including the number and type of risk factors, were similar between early and routine screening groups. Breslow-Day test for interaction between early versus routine screening and the number of additional risk factors was not significant for either the primary outcome (p = 0.37) or the diagnosis of GDM (p = 0.28). The incidence of GDM and the adverse perinatal composite outcome increased as the number of risk factors increased (p < 0.001). CONCLUSION: In patients with BMI ≥30 kg/m2 and additional risk factors, early GDM screening does not prevent adverse outcomes. KEY POINTS: · The ACOG currently recommends early screening for gestational diabetes if patients have risk factors.. · Even in patients with multiple risk factors, early screening for GDM does not improve outcomes.. · Patients with three or more risk factors may have worse outcomes if they undergo early screening..

Postpartum glucose intolerance following early gestational diabetes mellitus.

BACKGROUND: Patients with gestational diabetes mellitus are at increased risk for type 2 diabetes mellitus or glucose intolerance postpartum compared with those without diabetes mellitus. OBJECTIVE: We aimed to evaluate the association between early gestational diabetes mellitus and postpartum dysglycemia compared with gestational diabetes mellitus diagnosed by routine screening in a cohort of patients with obesity. STUDY DESIGN: This was a secondary analysis of a randomized controlled trial of patients with obesity and singleton, nonanomalous gestations that compared early gestational diabetes mellitus screening at 14 to 20 weeks of gestation with routine screening at 24 to 28 weeks of gestation. Patients were included in this analysis if they were diagnosed with gestational diabetes mellitus at the primary study site. The primary outcome was postpartum dysglycemia, defined as any abnormality on 2-hour oral glucose tolerance test 6 weeks postpartum or clinical diagnosis based on hyperglycemia requiring pharmacotherapy after delivery with deferred glucose tolerance test. Maternal characteristics and outcomes were compared in bivariable analysis, and logistic regression estimated the association between early gestational diabetes mellitus and postpartum dysglycemia. RESULTS: Of 119 patients included in this analysis, 30 were diagnosed by screening at <20 weeks of gestation and 89 at 24 to 28 weeks of gestation. Patients were overall similar in baseline characteristics. Patients with early gestational diabetes mellitus were more likely to have postpartum dysglycemia than those with gestational diabetes mellitus diagnosed with routine screening (36.7% vs 14.6%; odds ratio, 3.38; 95% confidence interval, 1.31-8.73). Most patients with early gestational diabetes mellitus who had postpartum dysglycemia were diagnosed clinically (n=7/11), whereas none of the patients with gestational diabetes mellitus established by routine testing were diagnosed with postpartum dysglycemia clinically. All (100%) patients with early gestational diabetes mellitus who completed a postpartum glucose tolerance test had dysglycemia compared with only 45% of patients with gestational diabetes mellitus diagnosed on routine screening. The proportion of patients who followed up for postpartum visits and the timing of follow-up were similar between groups. Postpartum glucose tolerance test completion was low but also similar between groups. CONCLUSION: Although postpartum glucose tolerance test completion is low, patients with gestational diabetes mellitus before 20 weeks of gestation, seem to be at higher risk for postpartum dysglycemia than those with gestational diabetes mellitus diagnosed at routine screening in a cohort of patients with obesity. Larger studies are needed to confirm these findings, but postpartum follow-up and diabetes mellitus testing may be even more important to improve long-term health in patients with early gestational diabetes mellitus.

Contemporary Test Performance of the Random Urine Protein-to-creatinine Ratio.

OBJECTIVE: The random urine protein-to-creatinine ratio (UPCR) is a screening test used for predicting clinically significant proteinuria (urine protein ≥ 300 mg) during pregnancy. No consensus exists on the optimal random UPCR cutoff for performing follow-up 24 hour urine (24H) total protein collection. We aim to evaluate the test performance of random UPCR in predicting proteinuria in a contemporary cohort. STUDY DESIGN: This was a retrospective cohort study of pregnant patients at our institution from 2014 to 2018 with a random UPCR and follow-up 24H protein collection. The primary analysis estimated the test characteristics (sensitivity, specificity, positive and negative predictive values) of using random UPCR for the detection of proteinuria defined as urine protein ≥300 mg on 24H protein collection. UPCR cutoffs from 0.10 to 0.30 mg/dL were evaluated, receiver operator characteristic (ROC) curve was constructed, and area under the curve (AUC) was determined. A secondary analysis examined the correlation between UPCR and 24H protein using least squares regression and Pearson correlation. RESULTS: Paired UPCR and 24H collection results were available for 1,120 patients. Mean gestational age at time of UPCR was 31.1 ± 5.1 weeks and 687 (61.3%) of patients had a 24H ≥300 mg. UPCR <0.10 mg/dL effectively excluded proteinuria ≥300 mg on 24H collection, while UPCR ≥0.18 mg/dL correctly classifies proteinuria with 91% sensitivity, 57% specificity, 77% positive predictive value, and 79% negative predictive value. UPCR ≥1.07 mg/dL had 100% specificity for 24 hour proteinuria. The area under ROC curve was 0.86. UPCR and 24H collection were highly correlated with a Pearson correlation coefficient of 0.85. After our institution lowered the threshold to obtain a 24H from UPCR ≥0.20 mg/dL to ≥0.10 mg/dL in May 2017, the percentage of patients meeting criteria for 24H collection increased from 57.8 to 84.4%. CONCLUSION: The AUC and Pearson correlation suggest random UPCR is a high performance test for the prediction of proteinuria on 24H. Optimal test performance is dependent upon clinical consideration and upon the implications of the disease or condition. A random UPCR screen positive threshold of 0.18 mg/dL maximizes sensitivity to identify clinically significant proteinuria. KEY POINTS: · Random urine protein to creatinine ratio is a high performance test for proteinuria.. · A random UPCR threshold of 0.18 mg/dL maximizes sensitivity to identify proteinuria.. · Optimal test performance is dependent on the disease or clinical condition..

Factors Associated with Appropriate Gestational Weight Gain among Women with Obesity.

OBJECTIVE: This study aimed to compare attendance of nutritional counseling, dietary composition, exercise patterns, and socioeconomic factors among obese women with inappropriate gestational weight gain (iGWG) versus appropriate GWG (aGWG). STUDY DESIGN: Medicaid-eligible women receiving prenatal care at a tertiary care center from January 2013 to December 2015 were offered individualized nutritional counseling by a registered dietitian encouraging well-balanced meals and 150 min/wk of exercise. We conducted a prospective case-control study of obese women (body mass index or BMI ≥30) with a singleton gestation with iGWG (<11 or >20 pounds) versus aGWG (11-20 pounds). Dietary intake, activity level, and socioeconomic factors were compared with Chi-square, Fisher's exact, Student's t-test, and Wilcoxon Rank Sum tests as indicated, and odds ratios with 95% confidence intervals were calculated. Multivariate regression analysis for significant variables was performed. A subgroup analysis of women with BMI ≥40 was planned. RESULTS: A total of 401 women were analyzed: 78% (n = 313) with iGWG and 22% (n = 88) with aGWG. Demographics were similar between groups. Women with iGWG less frequently reported physician reinforcement of counseling and reported more physical inactivity and unemployment; there were no differences in caloric intake or macronutrient profile between groups. Multivariate regression identified physician reinforcement and employment as independent predictors of aGWG. Among women with BMI ≥40 (n = 133), those with iGWG (78%) were less likely to attend counseling, report physician reinforcement of counseling, and have adequate caloric and protein intake when compared with those with aGWG (22%). Activity level and socioeconomic factors were not different between groups. CONCLUSION: Physician reinforcement of nutritional counseling, greater activity level, and employment are associated with aGWG in women with BMI ≥30, while individualized professional nutritional counseling and dietary modifications were further associated with aGWG in women with BMI ≥40. Thus, greater focus should be placed on enhancing exposure to counseling and altering nutritional and exercise choices to optimize aGWG. KEY POINTS: · Physician reinforcement of nutritional counseling by a dietitian is crucial for obese women.. · Physical inactivity and unemployment are associated with inappropriate gestational weight gain.. · Nutritional counseling is associated with appropriate gestational weight gain in women with BMI ≥40..

Gestational Weight Gain: Update on Outcomes and Interventions.

PURPOSE OF REVIEW: Gestational weight gain is a modifiable risk factor for adverse perinatal outcomes. After the Institute of Medicine (IOM) released updated recommendations for gestational weight gain in 2009, a multitude of studies were released examining the recommendations, particularly for women with obesity. As the obesity epidemic continues, many physicians are interested in minimizing gestational weight gain for all women. Our aim was to review the evidence for the association of gestational weight gain and perinatal outcomes, particularly for weight gain outside the IOM guidelines. RECENT FINDINGS: Gestational weight gain is associated with several adverse perinatal outcomes including fetal growth, preterm delivery, cesarean delivery, gestational diabetes, hypertensive disorders of pregnancy, and infant mortality as well as with long-term offspring metabolic health outcomes. Multiple randomized controlled trials have been conducted evaluating the efficacy of lifestyle intervention on gestational weight gain, and while lifestyle interventions may alter gestational weight gain, they have not been associated with improvement in perinatal outcomes. Weight loss during pregnancy is associated with decreased risks of macrosomia and cesarean delivery; however, given an association with low birth weight, it is not currently recommended. Excessive gestational weight gain is known to be associated with multiple adverse fetal and maternal outcomes. Lifestyle interventions during pregnancy may be helpful in decreasing excessive weight gain, but have not shown to be beneficial for most adverse pregnancy outcomes. More research is needed before making recommendations for weight loss in women with obesity during pregnancy.

Characteristics of African American women at high-risk for ovarian cancer in the southeast: Results from a Gynecologic Cancer Risk Assessment Clinic.

OBJECTIVES: Describe patient characteristics in African American (AA) women seen for gynecologic cancer related genetic counseling at a large southeastern comprehensive cancer center. METHODS: We reviewed an IRB approved, prospective observational cohort of patients from a Gynecologic Cancer Risk Assessment Clinic. Data evaluated included personal cancer history, family history, frequency of genetic testing, frequency/type of genetic mutations, and frequency of surgical intervention. Standard statistical statistics were utilized. RESULTS: 1227 patients were evaluated from 2003 to 2015, of which 95 (7.7%) were AA. Sixteen patients had a personal history of ovarian cancer. 21 women (22%) underwent genetic counseling only; subsequent genetic testing was not recommended based on absence of risk factors. Of the seventy-four AA patients in whom genetic testing was recommended, sixty-six (69.5%) completed testing. Of women tested, 37 (56%) had abnormal results. Eight and 14 patients had pathogenic variants in BRCA1 and BRCA2, respectively. Two were found to have pathogenic PALB2 variants; one had a pathogenic ATM variant and one constitutional MLH1 epimutation case was identified. Eleven had BRCA variants of uncertain significance. Of the patients with abnormal testing, six of 22 women with pathogenic BRCA variants underwent risk-reducing salpingo-oophorectomy (RRSO). CONCLUSIONS: Our study demonstrates that in a region where AAs represent 27% of the population, the proportion of AA patients referred to a Gynecologic Cancer Risk Assessment Clinic remains low. Pathogenic variant and variant of uncertain significance rates were high in patients tested, likely representing a selection bias of high-risk patients. Endeavors should continue to identify minorities at risk for ovarian cancer and institute measures to provide thorough genetic counseling and testing.