Garrett K. Lam

Digoxin immune fab treatment for severe preeclampsia.

We evaluated the efficacy, safety, and biological mechanisms of digoxin immune Fab (DIF) treatment of severe preeclampsia. Fifty-one severe preeclamptic patients were randomized in double-blind fashion to DIF ( N = 24) or placebo ( N = 27) for 48 hours. Primary outcomes were change in creatinine clearance (CrCl) at 24 to 48 hours and antihypertensive drug use. Serum sodium pump inhibition, a sequela of endogenous digitalis-like factors (EDLF), was also assessed. CrCl in DIF subjects was essentially unchanged from baseline versus a decrease with placebo (-3 +/- 10 and -34 +/- 10 mL/min, respectively, P = 0.02). Antihypertensive use was similar between treatments (46 and 52%, respectively, P = 0.7). Serum sodium pump inhibition was decreased with DIF compared with placebo at 24 hours after treatment initiation (least squares mean difference, 19 percentage points, P = 0.03). DIF appeared to be well tolerated. These results suggest DIF prevents a decline in renal function in severe preeclampsia by neutralizing EDLF. Sodium pump inhibition was significantly improved. Further research is warranted.

Development and validation of a spontaneous preterm delivery predictor in asymptomatic women.

BACKGROUND Preterm delivery remains the leading cause of perinatal mortality. Risk factors and biomarkers have traditionally failed to identify the majority of preterm deliveries. OBJECTIVE To develop and validate a mass spectrometry-based serum test to predict spontaneous preterm delivery in asymptomatic pregnant women. STUDY DESIGN A total of 5501 pregnant women were enrolled between 17(0/7) and 28(6/7) weeks gestational age in the prospective Proteomic Assessment of Preterm Risk study at 11 sites in the United States between 2011 and 2013. Maternal blood was collected at enrollment and outcomes collected following delivery. Maternal serum was processed by a proteomic workflow, and proteins were quantified by multiple reaction monitoring mass spectrometry. The discovery and verification process identified 2 serum proteins, insulin-like growth factor-binding protein 4 (IBP4) and sex hormone-binding globulin (SHBG), as predictors of spontaneous preterm delivery. We evaluated a predictor using the log ratio of the measures of IBP4 and SHBG (IBP4/SHBG) in a clinical validation study to classify spontaneous preterm delivery cases (<37(0/7) weeks gestational age) in a nested case-control cohort different from subjects used in discovery and verification. Strict blinding and independent statistical analyses were employed. RESULTS The predictor had an area under the receiver operating characteristic curve value of 0.75 and sensitivity and specificity of 0.75 and 0.74, respectively. The IBP4/SHBG predictor at this sensitivity and specificity had an odds ratio of 5.04 for spontaneous preterm delivery. Accuracy of the IBP4/SHBG predictor increased using earlier case-vs-control gestational age cutoffs (eg, <35(0/7) vs ≥35(0/7) weeks gestational age). Importantly, higher-risk subjects defined by the IBP4/SHBG predictor score generally gave birth earlier than lower-risk subjects. CONCLUSION A serum-based molecular predictor identifies asymptomatic pregnant women at risk of spontaneous preterm delivery, which may provide utility in identifying women at risk at an early stage of pregnancy to allow for clinical intervention. This early detection would guide enhanced levels of care and accelerate development of clinical strategies to prevent preterm delivery.

O009 AN OBSERVATIONAL STUDY OF THE USE OF A DUAL BALLOON CATHETER (BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM) FOR POSTPARTUM HEMORRHAGE – PRELIMINARY RESULTS

O009 AN OBSERVATIONAL STUDY OF THE USE OF A DUAL BALLOON CATHETER (BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM) FOR POSTPARTUM HEMORRHAGE – PRELIMINARY RESULTS K. DeStefano, C. Polon, G. Lam, O.W. Jones, J. Bukkapatnam, E. Rockholt, C. Robinson, S. Sunderji, J. Van Hook, R. Massaro, D. Adair, M. Belfort, G.A. Dildy. North Austin Medical Center, Austin, TX, United States; St. Davids Medical Center, Austin, TX, United States; Regional Obstetrical Consultants, Chattanooga, TN, United States; Obstetrix Medical Group of Colorado, Denver, CO, United States; Orlando Health, Inc, Orlando, FL, United States; Medical University of South Carolina, Charleston, SC, United States; The Toledo Hospital, Toledo, OH, United States; University of Cincinnati, Cincinnati, OH, United States; Monmouth Medical Center, Long Branch, NJ, United States; Glenveigh Medical, Chattanooga, TN, United States; Baylor College of Medicine, Houston, TX, United States