281 results match your criteria: "George Washington University Biostatistics Center[Affiliation]"

Background: Cesarean delivery in the second stage of labor is common, whereas the frequency of operative vaginal delivery has been declining. However, data comparing outcomes for attempted operative vaginal delivery vs cesarean in the second stage are scant. Previous studies that examine operative vaginal delivery have compared it to a baseline risk of complications from a spontaneous vaginal delivery and cesarean delivery.

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Objective: Children whose parents have diabetes are at increased risk for developing type 2 diabetes. This report assessed relationships between parental diabetes status and baseline demographics, anthropometrics, metabolic measurements, insulin sensitivity, and β-cell function in children recently diagnosed with type 2 diabetes.

Research Design And Methods: The sample included 632 youth (aged 10-17 years) diagnosed with type 2 diabetes for <2 years who participated in the TODAY clinical trial.

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Objective: To determine whether clinically accessible parameters early in the course of youth-onset type 2 diabetes predict likelihood of durable control on oral therapy.

Research Design And Methods: TODAY was a randomized clinical trial of adolescents with type 2 diabetes. Two groups, including participants from all three treatments, were defined for analysis: (1) those who remained in glycemic control for at least 48 months of follow-up and (2) those who lost glycemic control before 48 months.

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Background/aims: Conducting longitudinal research related to chronic illness in adolescents is inherently challenging due to developmental changes and psychosocial stressors. Participants in the Treatment Options for type 2 Diabetes in Adolescents and Youth clinical trial were socioeconomically disadvantaged as well. This study assessed attitudes and beliefs about retention in Treatment Options for type 2 Diabetes in Adolescents and Youth to shed light on the factors that potentially promote and detract from the likelihood of sustained participation.

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Objective: The aim of the study is to evaluate the association of steroid metabolism and respiratory gene polymorphisms in neonates exposed to antenatal corticosteroids (ACS) with respiratory outcomes, small for gestational age (SGA), and response to repeat ACS.

Study Design: This candidate gene study is a secondary analysis of women enrolled in a randomized controlled trial of single versus weekly courses of ACS. Nineteen single nucleotide polymorphisms (SNPs) in 13 steroid metabolism and respiratory function genes were evaluated.

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A Randomized Trial of Intrapartum Fetal ECG ST-Segment Analysis.

N Engl J Med

August 2015

From the University of Utah Health Sciences Center, Salt Lake City (M.A.B.); University of Texas Medical Branch, Galveston (G.R.S.); the George Washington University Biostatistics Center, Washington, DC (E.T.); the University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston (S.C.B.); the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD (U.M.R.); University of North Carolina at Chapel Hill, Chapel Hill (J.M.T.); University of Alabama at Birmingham, Birmingham (A.T.N.T.); Columbia University, New York (R.S.M.); Northwestern University, Chicago (A.M.P.); Ohio State University, Columbus (D.S.M.); MetroHealth Medical Center-Case Western Reserve University, Cleveland (E.K.S.C.); Brown University, Providence, RI (D.J.R.); University of Colorado School of Medicine, Anschutz Medical Campus, Aurora (R.S.G.); Stanford University, Stanford, CA (Y.Y.E.-S.); Wayne State University, Detroit (Y.S.); University of Pittsburgh, Pittsburgh (S.N.C.); and Medical University of South Carolina, Charleston (J.P.V.D.).

Background: It is unclear whether using fetal electrocardiographic (ECG) ST-segment analysis as an adjunct to conventional intrapartum electronic fetal heart-rate monitoring modifies intrapartum and neonatal outcomes.

Methods: We performed a multicenter trial in which women with a singleton fetus who were attempting vaginal delivery at more than 36 weeks of gestation and who had cervical dilation of 2 to 7 cm were randomly assigned to "open" or "masked" monitoring with fetal ST-segment analysis. The masked system functioned as a normal fetal heart-rate monitor.

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Objective: We sought to describe the prevalence of serious maternal complications following early preterm birth by gestational age (GA), delivery route, and type of cesarean incision.

Study Design: Trained personnel abstracted data from maternal and neonatal charts for all deliveries on randomly selected days representing one third of deliveries across 25 US hospitals over 3 years (n = 115,502). All women delivering nonanomalous singletons between 23-33 weeks' gestation were included.

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Objective: The purpose of this study was to examine the association between gestational age (GA) at the time of treatment initiation for gestational diabetes mellitus (GDM) and maternal and perinatal outcomes.

Study Design: We conducted a secondary analysis of a multicenter randomized treatment trial of mild GDM in which women with mild GDM were assigned randomly to treatment vs usual care. The primary outcome of the original trial, as well as this analysis, was a composite perinatal adverse outcome that included neonatal hypoglycemia, hyperbilirubinemia, hyperinsulinemia, and perinatal death.

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Effect of Sitagliptin on Cardiovascular Outcomes in Type 2 Diabetes.

N Engl J Med

July 2015

From the Duke Clinical Research Institute, Duke University School of Medicine, Durham (J.B.G., J.G., M.J.P., E.D.P.) and University of North Carolina School of Medicine, Chapel Hill (J.B.B.) - both in North Carolina; Diabetes Trials Unit, Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, United Kingdom (M.A.B., R.R.H.); Canadian VIGOUR Centre, University of Alberta, Edmonton, AB (P.W.A.) and St. Michael's Hospital, University of Toronto, Toronto (R.J.) - both in Canada; Merck, Kenilworth, NJ (S.S.E., K.D.K., J.K., S.K., P.P.S., S.S.); George Washington University Biostatistics Center, Rockville, MD (J.M.L.); University of Texas Southwestern Medical Center, Dallas (D.K.M.); Munich Diabetes Research Group, Helmholtz Center, Neuherberg, Germany (E.S.); and University of Leuven, Leuven, Belgium (F.V.W.).

Background: Data are lacking on the long-term effect on cardiovascular events of adding sitagliptin, a dipeptidyl peptidase 4 inhibitor, to usual care in patients with type 2 diabetes and cardiovascular disease.

Methods: In this randomized, double-blind study, we assigned 14,671 patients to add either sitagliptin or placebo to their existing therapy. Open-label use of antihyperglycemic therapy was encouraged as required, aimed at reaching individually appropriate glycemic targets in all patients.

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Racial and ethnic disparities in maternal morbidity and obstetric care.

Obstet Gynecol

June 2015

Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois; Case Western Reserve University-MetroHealth Medical Center, Cleveland, Ohio; Columbia University, New York, New York; University of Utah Health Sciences Center, Salt Lake City, Utah; the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; the University of Texas Southwestern Medical Center, Dallas, Texas; the University of Pittsburgh, Pittsburgh, Pennsylvania; The Ohio State University, Columbus, Ohio; the University of Alabama at Birmingham, Birmingham, Alabama; the University of Texas Medical Branch, Galveston, Texas; Brown University, Providence, Rhode Island; the University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas; Oregon Health & Science University, Portland, Oregon; the Medical University of South Carolina, Charleston, South Carolina; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To evaluate whether racial and ethnic disparities exist in obstetric care and adverse outcomes.

Methods: We analyzed data from a cohort of women who delivered at 25 hospitals across the United States over a 3-year period. Race and ethnicity was categorized as non-Hispanic white, non-Hispanic black, Hispanic, or Asian.

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Objective: We sought to evaluate the frequency of, and factors associated with, the use of 3 evidence-based interventions: antenatal corticosteroids for fetal lung maturity, progesterone for prevention of recurrent preterm birth, and magnesium sulfate for fetal neuroprotection.

Study Design: A self-administered survey was conducted from January through May 2011 among obstetricians from 21 hospitals that included 30 questions regarding their knowledge, attitudes, and practice of the 3 evidence-based interventions and the 14-item short version of the Team Climate for Innovation survey. Frequency of use of each intervention was ascertained from an obstetrical cohort of women between January 2010 and February 2011.

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Objective: This study examined parental factors associated with outcomes of youth in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) clinical trial.

Research Design And Methods: Of 699 youth with type 2 diabetes in the TODAY cohort, 623 (89.1%) had a parent participate and provide data at baseline, including weight, HbA1c, blood pressure, symptoms of depression, binge eating (BE), and medical history.

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Morbidly adherent placenta treatments and outcomes.

Obstet Gynecol

March 2015

Departments of Obstetrics and Gynecology, Case Western Reserve University, MetroHealth Medical Center, Cleveland, Ohio; Prentice Women's Hospital, Northwestern University, Chicago, Illinois; Columbia University, New York, New York; the University of Utah Health Sciences Center, Salt Lake City, Utah; the University of Texas Southwestern Medical Center, Dallas, the University of Texas Medical Branch, Galveston, and the University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas; The Ohio State University, Columbus, Ohio; the University of Alabama at Birmingham, Birmingham, Alabama; Brown University, Providence, Rhode Island; The George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To describe recent maternal and neonatal delivery outcomes among women with a morbidly adherent placenta in major centers across the United States.

Methods: This study reviewed a cohort of 115,502 women and their neonates born in 25 hospitals in the United States between March 2008 and February 2011 from the Assessment of Perinatal EXcellence data set. All cases of morbidly adherent placenta were identified.

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Objective: The aim of the study was to evaluate associations between fetal growth and weight at 2 years in infants born preterm using a customized approach for birth weight.

Study Design: This is a secondary analysis of a multicenter trial that included a 2-year follow-up of children born prematurely. Customized birth weight percentiles were calculated using the Gardosi model for a U.

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Uric Acid Determination in Gestational Hypertension: Is it as Effective a Delineator of Risk as Proteinuria in High-Risk Women?

Reprod Sci

October 2015

Magee-Womens Research Institute, Pittsburgh, PA, USA Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Pittsburgh, PA, USA Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA, USA Clinical and Translational Science Institute, University of Pittsburgh, Pittsburgh, PA, USA.

We asked, is uric acid as effective as proteinuria at identifying perinatal risk in high-risk women with gestational hypertension? Uric acid was measured in samples obtained ≈4.6 weeks predelivery in 259 women with prior preeclampsia from the National Institute of Child Health and Human Development network study of low-dose aspirin to prevent preeclampsia. Participants were grouped according to the presence/absence of gestational hypertension (H), proteinuria (P), and hyperuricemia (U).

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The effect of lifestyle intervention and metformin on preventing or delaying diabetes among women with and without gestational diabetes: the Diabetes Prevention Program outcomes study 10-year follow-up.

J Clin Endocrinol Metab

April 2015

MedStar Health Research Institute (V.R.A., R.E.R.), Hyattsville, Maryland 20782; George Washington University Biostatistics Center (C.A.C., S.L.E.), Rockville, Maryland 20852; Centers for Disease Control and Prevention (P.Z., X.Z.), Atlanta, Georgia 30333; University of Michigan (W.H.H.), Ann Arbor, Michigan 48109; University of California, San Diego (E.B.-C.), La Jolla, California 92093; Massachusetts General Hospital and Harvard Medical School (L.M.D.), Boston, Massachusetts 02114; University of Texas Health Science Center at San Antonio (M.G.M.), San Antonio, Texas 78229; Northwestern University Feinberg School of Medicine (R.T.A.), Chicago, Illinois 60611; and National Institute of Diabetes and Digestive and Kidney Diseases (W.C.K.), Phoenix, Arizona 85014.

Context: Gestational diabetes (GDM) confers a high risk of type 2 diabetes. In the Diabetes Prevention Program (DPP), intensive lifestyle (ILS) and metformin prevented or delayed diabetes in women with a history of GDM.

Objective: The objective of the study was to evaluate the impact of ILS and metformin intervention over 10 years in women with and without a history of GDM in the DPP/Diabetes Prevention Program Outcomes Study.

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Objective: We sought to evaluate whether the presence of condition-specific obstetric protocols within a hospital was associated with better maternal and neonatal outcomes.

Study Design: This was a cohort study of a random sample of deliveries performed at 25 hospitals over 3 years. Condition-specific protocols were collected from all hospitals and categorized independently by 2 authors.

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Objective: To determine whether β2 -adrenoceptor (β2 AR) genotype is associated with shortening of the cervix or with preterm birth (PTB) risk among women with a short cervix in the second trimester.

Design: A case-control ancillary study to a multicentre randomised controlled trial.

Setting: Fourteen participating centres of the Maternal-Fetal Medicine Units Network of the Eunice Kennedy Shriver National Institute of Child Health and Human Development.

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Objective: This study aims to determine whether there is a threshold 3-hour oral glucose tolerance test (OGTT) value associated with accelerated risk of adverse pregnancy outcomes.

Study Design: In a secondary analysis of a cohort of women with untreated mild gestational glucose intolerance, we used generalized additive models with smoothing splines to explore nonlinear associations between each of the 3-hour OGTT values (fasting, 1-hour, 2-hour, and 3-hour) and adverse pregnancy outcomes, including the study's composite outcome (perinatal mortality, hypoglycemia, hyperbilirubinemia, neonatal hyperinsulinemia, and/or birth trauma), large for gestational age birth weight, small for gestational age birth weight, shoulder dystocia, neonatal hypoglycemia, gestational hypertension (gHTN), and preeclampsia.

Results: Among the 1,360 eligible women, each timed OGTT value was linearly associated with increased odds of composite adverse outcome.

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Importance: Whether mortality in type 1 diabetes mellitus is affected following intensive glycemic therapy has not been established.

Objective: To determine whether mortality differed between the original intensive and conventional treatment groups in the long-term follow-up of the Diabetes Control and Complications Trial (DCCT) cohort.

Design, Setting, And Participants: After the DCCT (1983-1993) ended, participants were followed up in a multisite (27 US and Canadian academic clinical centers) observational study (Epidemiology of Diabetes Control and Complications [EDIC]) until December 31, 2012.

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Objective: Smoking and pre-eclampsia (PE) are associated with increases in preterm birth, placental abruption and low birthweight. We evaluated the relationship between prenatal vitamin C and E (C/E) supplementation and perinatal outcomes by maternal self-reported smoking status focusing on outcomes known to be impacted by maternal smoking.

Design/setting/population: A secondary analysis of a multi-centre trial of vitamin C/E supplementation starting at 9-16 weeks in low-risk nulliparous women with singleton gestations.

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Laboratory abnormalities in pregnancy-associated hypertension: frequency and association with pregnancy outcomes.

Obstet Gynecol

November 2014

Departments of Obstetrics and Gynecology, the University of Alabama at Birmingham, Birmingham, Alabama; the University of Pittsburgh, Pittsburgh, Pennsylvania; the University of Texas Southwestern Medical Center, Dallas, Texas; the University of Cincinnati, Cincinnati, Ohio; the University of Utah, Salt Lake City, Utah; Columbia University, New York, New York; the University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Case Western Reserve University-MetroHealth Medical Center, Cleveland, Ohio; Northwestern University, Chicago, Illinois; the University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas; The Ohio State University, Columbus, Ohio; Drexel University, Philadelphia, Pennsylvania; the University of Texas Medical Branch, Galveston, Texas; Wayne State University, Detroit, Michigan; the George Washington University Biostatistics Center, Washington, DC; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.

Objective: To estimate the frequency of abnormal laboratory test results in pregnancy-associated hypertension and the relationship with pregnancy outcomes.

Methods: This was a secondary analysis of a multicenter trial of vitamin C and E for prevention of pregnancy-associated hypertension in low-risk nulliparous women. Laboratory abnormalities included: platelets less than 100,000/mm, aspartate aminotransferase 100 units/L or greater, creatinine 1.

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Accuracy of sonographic chorionicity classification in twin gestations.

J Ultrasound Med

December 2014

Department of Obstetrics and Gynecology, Stanford University School of Medicine, Stanford, California USA (Y.J.B.); George Washington University Biostatistics Center, Washington, DC USA (V.M.); Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, Alabama USA (D.J.R.); University of Pittsburgh, Pittsburgh, Pennsylvania USA (S.N.C.); Drexel University, Philadelphia, Pennsylvania USA (A.C.S.); Northwestern University, Chicago, Illinois USA (A.M.P.); Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland USA (U.M.R.); University of Utah, Salt Lake City, Utah USA (M.W.V); Columbia University, New York, New York USA (F.D.M.); The Ohio State University, Columbus, Ohio USA (J.D.I); Case Western Reserve University-MetroHealth Medical Center, Cleveland, Ohio USA (B.M.M); University of North Carolina, Chapel Hill, North Carolina USA (J.M.T.); Wayne State University, Detroit, Michigan USA (Y.S); Brown University, Providence, Rhode Island USA (M.W.C.); University of Texas Southwestern Medical Center, Dallas, Texas USA (J.L); University of Texas Health Science Center, Houston, Texas USA (S.M.R.); and Wake Forest University Health Sciences, Winston-Salem, North Carolina USA (M.H.).

Objectives: To evaluate the accuracy of sonographic classification of chorionicity in a large cohort of twins and investigate which factors may be associated with sonographic accuracy.

Methods: We conducted a secondary analysis of a randomized trial of preterm birth prevention in twins. Sonographic classification of chorionicity was compared with pathologic examination of the placenta.

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Objective: To evaluate whether treatment of mild gestational diabetes mellitus (GDM) confers sustained offspring health benefits, including a lower frequency of obesity.

Research Design And Methods: Follow-up study of children (ages 5-10) of women enrolled in a multicenter trial of treatment versus no treatment of mild GDM. Height, weight, blood pressure, waist circumference, fasting glucose, fasting insulin, triglycerides, and HDL cholesterol were measured.

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