281 results match your criteria: "George Washington University Biostatistics Center[Affiliation]"
Characteristics Associated With Consent and Reasons for Declining in a Randomized Trial in Pregnancy.
Obstet Gynecol
October 2020
Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch at Galveston, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Pennsylvania, Philadelphia, Pennsylvania, and University of Pittsburgh, Pittsburgh, Pennsylvania; and the George Washington University Biostatistics Center, Washington, DC.
Objective: To evaluate the maternal characteristics associated with consent to a randomized trial of labor induction in pregnancy.
Methods: This is a secondary analysis of low-risk nulliparous women randomized to induction of labor at 39 weeks or expectant management. During the trial, the Data and Safety Monitoring Committee requested additional fields on the screening log, which already included race and ethnicity: maternal age, type of insurance, and the reason for declining consent if declined.
Elective Labor Induction at 39 Weeks of Gestation Compared With Expectant Management: Factors Associated With Adverse Outcomes in Low-Risk Nulliparous Women.
Obstet Gynecol
October 2020
Departments of Obstetrics and Gynecology, Stanford University, Stanford, California, Northwestern University, Chicago, Illinois, University of Alabama at Birmingham, Birmingham, Alabama, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, Brown University, Providence, Rhode Island, University of Texas Medical Branch, Galveston, Texas, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, The Ohio State University, Columbus, Ohio, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Pennsylvania, Philadelphia, Pennsylvania, Duke University, Durham, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, Washington University in St. Louis, St. Louis, Missouri; 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 characteristics associated with adverse outcomes in low-risk nulliparous women randomized to elective labor induction at 39 weeks of gestation or expectant management.
Methods: We conducted a secondary analysis of women randomized during the 38th week to induction at 39 weeks of gestation or expectant management. Deliveries before 39 weeks of gestation and those not adherent to study protocol or with fetal anomalies were excluded.
Objective: Our objective was to compare outcomes among low-risk parous women who underwent elective labor induction at 39 weeks versus expectant management.
Study Design: This is a secondary analysis of an observational cohort of 115,502 mother-infant dyads who delivered at 25 hospitals between 2008 and 2011. The inclusion criteria for this analysis were low-risk parous women with nonanomalous singletons with at least one prior vaginal delivery after 20 weeks, who delivered at ≥39 weeks.
β-cells in youth with impaired glucose tolerance or early type 2 diabetes secrete more insulin and are more responsive than in adults.
Pediatr Diabetes
December 2020
Institute of Neuroscience, National Research Council, Padova, Italy.
Objective: Glycemic control deteriorates more rapidly in youth vs adults. We compared model-derived measures of β-cell function between youth and adults with either impaired glucose tolerance (IGT) or type 2 diabetes to determine if a β-cell defect differentiates these age groups.
Methods: This is a cross-sectional analysis of baseline data from the Restoring Insulin Secretion (RISE) Study.
Neonatal and Maternal Composite Adverse Outcomes Among Low-Risk Nulliparous Women Compared With Multiparous Women at 39-41 Weeks of Gestation.
Obstet Gynecol
September 2020
Departments of Obstetrics and Gynecology, University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, Texas, Northwestern University, Chicago, Illinois, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Columbia University, New York, New York, University of Utah Health Sciences Center, Salt Lake City, Utah, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, The Ohio State University, Columbus, Ohio, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch, Galveston, Texas, Wayne State University, Detroit, Michigan, Brown University, Providence, Rhode Island, and Oregon Health & Science University, Portland, Oregon; 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 whether the frequency of adverse maternal and neonatal outcomes differs between low-risk nulliparous and multiparous women at 39-41 weeks of gestation.
Methods: This is a secondary analysis of an observational obstetrics cohort of maternal-neonatal dyads at 25 hospitals. Low-risk women with nonanomalous singletons who delivered between 39 0/7 and 41 6/7 weeks of gestation were included.
Antenatal Corticosteroids and Preterm Neonatal Morbidity and Mortality among Women with and without Diabetes in Pregnancy.
Am J Perinatol
January 2022
Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon.
Objective: The objective of this study was to determine whether antenatal corticosteroid exposure has a differential association with preterm neonatal morbidity among women with and without diabetes.
Study Design: Secondary analysis of an observational cohort of 115,502 women and their neonates born in 25 U.S.
Fibroblast Growth Factor 21 and Metabolic Dysfunction in Women with a Prior Glucose-Intolerant Pregnancy.
Am J Perinatol
November 2021
Department of Obstetrics and Gynecology, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas.
Objective: We sought to determine if there is an association between fibroblast growth factor 21 (FGF21) levels and a history of gestational diabetes mellitus (GDM) in women with and without metabolic dysfunction, defined as a diagnosis of metabolic syndrome or type 2 diabetes (T2DM), 5 to 10 years following participation in a multiple cohort GDM study.
Study Design: At 5 to 10 years after index pregnancy, women underwent a follow-up visit and were categorized as having no metabolic syndrome, metabolic syndrome, or T2DM. FGF21 levels were compared between women who did and did not have a history of GDM using multivariable linear regression.
Cost of Elective Labor Induction Compared With Expectant Management in Nulliparous Women.
Obstet Gynecol
July 2020
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and the Division of Epidemiology, Department of Internal Medicine, University of Utah Health, Intermountain Healthcare, and the IDEAS Center, VA Salt Lake City Healthcare System, Salt Lake City, Utah; George Washington University Biostatistics Center, Washington, DC; the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Objective: To compare the actual health-system cost of elective labor induction at 39 weeks of gestation with expectant management.
Methods: This was an economic analysis of patients enrolled in the five Utah hospitals participating in a multicenter randomized trial of elective labor induction at 39 weeks of gestation compared with expectant management in low-risk nulliparous women. The entire trial enrolled more than 6,000 patients.
Maternal and Neonatal Outcomes Associated with Amniotomy among Nulliparous Women Undergoing Labor Induction at Term.
Am J Perinatol
August 2021
Department of Obstetrics and Gynecology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Objective: The aim of the study is to evaluate the association between amniotomy at various time points during labor induction and maternal and neonatal outcomes among term, nulliparous women.
Study Design: Secondary analysis of a randomized trial of term labor induction versus expectant management in low-risk, nulliparous women (2014-2017) was conducted. Women met inclusion criteria if they underwent induction ≥38 weeks' gestation using oxytocin with documented time and type of membrane rupture.
Hepatitis C Virus Antibody Screening in a Cohort of Pregnant Women: Identifying Seroprevalence and Risk Factors.
Obstet Gynecol
April 2020
Departments of Obstetrics and Gynecology, The Ohio State University, Columbus, Ohio, University of Texas Medical Branch at Galveston, Galveston, Texas, Brown University, Providence, Rhode Island, University of Utah Health Sciences Center, Salt Lake City, Utah, Columbia University, New York, New York, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Alabama at Birmingham, Birmingham, Alabama, Duke University, Durham, North Carolina, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, University of Texas Southwestern Medical Center, Dallas, Texas, Northwestern University, Chicago, Illinois, Stanford University, Stanford, California, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, Colorado, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, and Washington University in St. Louis, St. Louis, Missouri; the Division of Viral Hepatitis, Centers for Disease Control and Prevention, Atlanta, Georgia; 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 the prevalence of hepatitis C virus (HCV) antibody, evaluate current risk factors associated with HCV antibody positivity, and identify novel composite risk factors for identification of groups most likely to demonstrate HCV antibody seropositivity in an obstetric population from 2012 to 2015.
Methods: The Eunice Kennedy Shriver National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network initiated an observational study of mother-to-child transmission of HCV in 2012 that included offering HCV antibody screening to their entire obstetric population. Women presenting for prenatal care before 23 weeks of gestation without a known multifetal gestation were eligible.
Effect of Thyroxine Therapy on Depressive Symptoms Among Women With Subclinical Hypothyroidism.
Obstet Gynecol
April 2020
Departments of Obstetrics and Gynecology, University of Texas Medical Branch, Galveston, Texas, University of Texas - Southwestern, Dallas, Texas, Northwestern University, Chicago, Illinois, University of Utah Health Sciences Center, Salt Lake City, Utah, Wayne State University, Detroit, Michigan, Columbia University, New York, New York, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Alabama at Birmingham, Birmingham, Alabama; Brown University, Providence, Rhode Island, University of Texas - Houston, Houston, Texas, The Ohio State University, Columbus, Ohio, Case Western Reserve University, Cleveland, Ohio, Oregon Health Sciences University, Portland, Oregon, University of Pittsburgh, Pittsburgh, Pennsylvania, Medical University of South Carolina, Charleston, South Carolina; and 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 effect of antenatal treatment of subclinical hypothyroidism on maternal depressive symptoms.
Methods: We conducted an ancillary study to a multicenter trial in women with singleton pregnancies diagnosed with subclinical hypothyroidism randomized to antenatal thyroxine therapy or placebo. Treatment was discontinued at the end of pregnancy.
Beta cell function and insulin sensitivity in obese youth with maturity onset diabetes of youth mutations vs type 2 diabetes in TODAY: Longitudinal observations and glycemic failure.
Pediatr Diabetes
June 2020
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Objective: In treatment options for type 2 diabetes in adolescents and youth (TODAY), 4.5% of obese youth clinically diagnosed with type 2 diabetes (T2D) had genetic variants consistent with maturity onset diabetes of youth (MODY) diagnosis. The course of IS and β-cell function in obese youth with MODY remains unknown.
View Article and Find Full Text PDFMaternal Sense of Control During Childbirth and Infant Feeding Method.
Obstet Gynecol
March 2020
Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois; George Washington University Biostatistics Center, Washington, DC; Department of Obstetrics and Gynecology, Yale University, New Haven, Connecticut; University of Alabama at Birmingham, Birmingham, Alabama; University of Utah Health Sciences Center, Salt Lake City, Utah; Stanford University, Stanford, California; Columbia University, New York, New York; Brown University, Providence, Rhode Island; University of Texas Medical Branch, Galveston, Texas; University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas; The Ohio State University, Columbus, Ohio; MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio; University of Texas Southwestern Medical Center, Dallas, Texas; University of Pennsylvania, Philadelphia, Pennsylvania; Duke University, Durham, North Carolina; and the University of Pittsburgh, Pittsburgh, Pennsylvania; for the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.
Objective: To estimate whether maternal sense of control in labor is associated with breastfeeding at 4-8 weeks postpartum.
Methods: This is a secondary analysis of data from a multicenter randomized controlled trial of elective induction of labor at 39 weeks of gestation in low-risk nulliparous women. In this trial, women completed the Labor Agentry Scale, a validated measure of women's feelings of control over the childbirth process, 6-96 hours after delivery.
Association Between Time of Day and the Decision for an Intrapartum Cesarean Delivery.
Obstet Gynecol
March 2020
Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, George Washington University Biostatistics Center, Washington, DC, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Yale University, New Haven, Connecticut, Columbia University, New York, New York, University of Utah Health Sciences Center, Salt Lake City, Utah, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Texas Southwestern Medical Center, Dallas, Texas, University of Pittsburgh, Pittsburgh, Pennsylvania, The Ohio State University, Columbus, Ohio, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch, Galveston, Texas, Wayne State University, Detroit, Michigan, Brown University, Providence, Rhode Island, University of Texas Health Science Center at Houston-Children's Memorial Hermann Hospital, Houston, Texas, and Oregon Health & Science University, Portland, Oregon.
Objective: To examine whether the decision and indications for performing intrapartum cesarean delivery vary by time of day.
Methods: We conducted a secondary analysis of a multicenter observational cohort of 115,502 deliveries (2008-2011), including nulliparous women with term, singleton, nonanomalous live gestations in vertex presentation who were attempting labor. Those who attempted home birth, or underwent cesarean delivery scheduled or decided less than 30 minutes after admission were excluded.
Health resource utilization of labor induction versus expectant management.
Am J Obstet Gynecol
April 2020
Washington University, Saint Louis, MO.
Background: Although induction of labor of low-risk nulliparous women at 39 weeks reduces the risk of cesarean delivery compared with expectant management, concern regarding more frequent use of labor induction remains, given that this intervention historically has been thought to incur greater resource utilization.
Objective: The objective of the study was to determine whether planned elective labor induction at 39 weeks among low-risk nulliparous women, compared with expectant management, was associated with differences in health care resource utilization from the time of randomization through 8 weeks postpartum.
Study Design: This is a planned secondary analysis of a multicenter randomized trial in which low-risk nulliparous women were assigned to induction of labor at 39 weeks or expectant management.
Steroid Hormone Levels in Recipient Amniotic Fluid in Twin-Twin Transfusion Syndrome and Their Association with Preterm Delivery.
Am J Perinatol
May 2020
Division of Maternal-Fetal Medicine, Department of Obstetrics, Gynecology, and Reproductive Sciences, McGovern Medical School, UTHealth, The University of Texas Health Science Center at Houston, Houston, Texas.
Objective: Preterm delivery following fetoscopic laser surgery (FLS) of twin-twin transfusion syndrome (TTTS) is associated with severe perinatal morbidity and mortality. The role of steroid hormones in amniotic fluid (AF) after FLS remains unknown.
Study Design: A prospective cohort study of consecutive case series of FLS for TTTS was performed from April 2012 to February 2017.
Adherence to multiple medications in the TODAY (Treatment Options for type 2 Diabetes in Adolescents and Youth) cohort: effect of additional medications on adherence to primary diabetes medication.
J Pediatr Endocrinol Metab
February 2020
Diabetes and Obesity Program, Children's Hospital Los Angeles, Los Angeles, CA, USA.
Background Non-adherence to diabetes medication leads to poor outcomes and increased healthcare costs. Multiple factors affecting adherence in adults with type 2 diabetes (T2D) have been identified, but pediatric data is sparse. We aimed to determine whether initiation of additional oral medications or insulin affects adherence to primary study medication (PSM) in the Treatment Options for type 2 Diabetes in Adolescents and Youth (TODAY) study.
View Article and Find Full Text PDFSimultaneous Evaluation of Diagnostic Assays for Pharyngeal and Rectal Neisseria gonorrhoeae and Chlamydia trachomatis Using a Master Protocol.
Clin Infect Dis
December 2020
University of California, Los Angeles, California, USA.
Background: Pharyngeal and rectal Neisseria gonorrhoeae and Chlamydia trachomatis play important roles in infection and antibacterial resistance transmission, but no US Food and Drug Administration (FDA)-cleared assays for detection at these sites existed prior to this study. The objective was to estimate performance of assays to detect those infections in pharyngeal and rectal specimens to support regulatory submission.
Methods: We performed a cross-sectional, single-visit study of adults seeking sexually transmitted infection testing at 9 clinics in 7 states.
Accuracy of Patient Reported Stone Passage for Patients With Acute Renal Colic Treated in the Emergency Department.
Urology
February 2020
Department of Urology, University of Pittsburgh School of Medicine, Pittsburgh, PA.
Objective: To study patients who initially presented to the Emergency Department with acute renal colic to determine if patient-reported stone passage detects stone expulsion as accurately as follow-up computed tomography (CT) scan.
Methods: This is a secondary analysis of a multi-center prospective trial of patients diagnosed by a CT scan with a symptomatic ureteral stone <9 mm in diameter. Patient-reported stone passage, defined as capture or visualization of the stone, was compared to CT scan-confirmed passage performed 29-36 days after initial presentation.
Editors' Expert Forum 2018: Managing Big Data for Diabetes Research and Care.
Diabetes Care
June 2019
American Diabetes Association, Arlington, VA.
Technological progress in the past half century has greatly increased our ability to collect, store, and transmit vast quantities of information, giving rise to the term "big data." This term refers to very large data sets that can be analyzed to identify patterns, trends, and associations. In medicine-including diabetes care and research-big data come from three main sources: electronic medical records (EMRs), surveys and registries, and randomized controlled trials (RCTs).
View Article and Find Full Text PDFMyelomeningocele sac associated with worse lower-extremity neurological sequelae: evidence for prenatal neural stretch injury?
Ultrasound Obstet Gynecol
June 2020
Perelman School of Medicine, University of Pennsylvania, PA, USA.
Objective: To determine whether the presence of a myelomeningocele (MMC) sac and sac size correlate with compromised lower-extremity function in fetuses with open spinal dysraphism.
Methods: A radiology database search was performed to identify cases of MMC and myeloschisis (MS) diagnosed prenatally in a single center from 2013 to 2017. All cases were evaluated between 18 and 25 weeks.
Association Between Features of Spontaneous Late Preterm Labor and Late Preterm Birth.
Am J Perinatol
March 2020
Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.
Article Synopsis
- The study aimed to explore the link between clinical examination features at hospital admission and the occurrence of late preterm births in women who were in spontaneous labor at 34 to 36 weeks of pregnancy.
- A secondary analysis of a trial revealed that 59% of the 732 women studied delivered preterm, with cervical dilation and effacement measuring as key predictors of late preterm birth.
- The research concluded that including clinical factors like gestational age and nulliparity in predictions could notably enhance the accuracy of forecasting late preterm births, indicating that a significant portion of women still delivered at term despite being in late preterm labor.
Heart Rate Variability and Cardiac Autonomic Dysfunction: Prevalence, Risk Factors, and Relationship to Arterial Stiffness in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) Study.
Diabetes Care
November 2019
Cincinnati Children's Hospital Medical Center and University of Cincinnati, Cincinnati, OH.
Objective: To determine whether prior type 2 diabetes (T2D) treatment or glycemic control over time are independently associated with heart rate variability (HRV) and whether the presence of cardiac autonomic dysfunction is associated with arterial stiffness in young adults with youth-onset T2D enrolled in the Treatment Options for Type 2 Diabetes in Adolescents and Youth (TODAY) study.
Research Design And Methods: Heartbeats over 10 min were measured to derive the normal R-Rs (NN intervals). Outcomes included the standard deviation of the NN intervals (SDNN), the root mean square differences of successive NN intervals (RMSSD), percent of NN beats that differ by more than 50 ms (PNN50), and the low-frequency (LF) power domain, high-frequency (HF) power domain, and their ratio (LF:HF).
Objective: Poor sleep may increase obesity and type 2 diabetes (T2D) risk in youth. We explored whether subjective sleep duration, sleep quality, or risk for obstructive sleep apnea (OSA) are associated with glycemia, body mass index (BMI), or blood pressure (BP) in overweight/obese youth.
Methods: Two-hundred and fourteen overweight/obese youth of 10 to 19 years of age at risk for or recently diagnosed with T2D who were screened for the Restoring Insulin Secretion (RISE) Study had a 2-hour oral glucose tolerance test (OGTT) and completed a Cleveland Adolescent Sleepiness questionnaire and a Sleep Disturbances Scale questionnaire.
Association of Labor With Neonatal Respiratory Outcomes at 36-40 Weeks of Gestation.
Obstet Gynecol
September 2019
Departments of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois, MetroHealth Medical Center-Case Western Reserve University, Cleveland, Ohio, Columbia University, New York, New York, University of Utah Health Sciences Center, Salt Lake City, Utah, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, University of Pittsburgh, Pittsburgh, Pennsylvania, The Ohio State University, Columbus, Ohio, University of Alabama at Birmingham, Birmingham, Alabama, University of Texas Medical Branch, Galveston, Texas, Wayne State University, Detroit, Michigan, Brown University, Providence, Rhode Island, University of Texas Health Science Center at Houston, McGovern Medical School-Children's Memorial Hermann Hospital, Houston, Texas, and Oregon Health & Science University, Portland, Oregon; and 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 labor is associated with lower odds of respiratory morbidity among neonates born from 36 to 40 weeks of gestation and to assess whether this association varies by gestational age and maternal diabetic status.
Methods: We conducted a secondary analysis of women in the Assessment of Perinatal Excellence obstetric cohort who delivered across 25 U.S.