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3D DOPPLER AND INTRAUTERINE GROWTH RESTRICITON
PI: Katie Goetzinger, MD • CRNC: Linda Odibo, RN, BSc, MN
A prospective cohort study to determine if IUGR fetuses are more likely to exhibit evidence of altered cerebral blood flow compared to normal fetuses when quantified using 3-D power Doppler studies. Recruitment will occur in the Obstetric Ultrasound department in the Center for Advance Medicine, and 300 patients will be enrolled: 150 IUGR and 150 controls.

ANTISEPTIC SKIN PREPARATION FOR PREVENTING SURGICAL SITE INFECTION AT CESAREAN DELIVERY

 PI: Methodius Tuuli, MD, MPH • CRNC: Patty Fogertey, RN, MSN
This is a randomized controlled trial to determine the comparative effectiveness of chlorhexidine-alcohol and iodine-alcohol preoperative skin preparation for preventing surgical site infections at cesarean section. All women undergoing cesarean delivery at Barnes-Jewish Hospital will be eligible and will be randomized on a 1:1 ratio to the use of Chlorhexidine-alcohol or Iodine-alcohol. A total of 1200 women will be recruited.

BACTERIAL-HOST INTERACTIONS IN BLOOD AND AMNIOTIC FLUID
PI: Amanda Lewis, PhD
The aim of the study is to examine the impact of bacterial surface carbohydrate structures on mechanisms of survival in blood and amniotic fluid and the potential consequences of bacterial products on proinflammatory cytokine induction. Approximately 100 samples of each of the following specimens: blood, umbilical cord blood, and amniotic fluid, through the WIHSC over a 2-year period.

CERVICAL DOPPLERS IN PREGANCY
PI: Jeffery Dicke, MD • RA: Lyndsay Roy
We hypothesize that cervical Doppler studies will reflect vascular remodeling during pregnancy and thus may be a useful tool to assess cervical softening and dilation in pregnancy. As the cervical artery undergoes vascular changes throughout gestation to enhance blood flow to the cervix, the intravascular resistance will decrease and the Doppler indices, including the S/D ratio and the PI ratio, will decrease. We hypothesize that cervical Doppler indices will progressively change throughout each trimester. A total of 100 women will be enrolled in the Obstetric Ultrasound department in the Center for Advance Medicine.

CERVICAL LENGTH SCREENING STUDY
PI: Jennifer McNamara, MD, Methodius Tuuli , MD, MPH • RA: Kristen Powers
A prospective observational study aimed at assessing the agreement between transabdominal cervical length assessment to transvaginal cervical length assessment and to estimate if short cervical length in women with prior preterm birth who are on 17 OHP is predictive of therapeutic failure (recurrent preterm delivery). A total of 410 women will be recruited between 17 and 23 weeks gestation from the Obstetric Ultrasound department in the Center for Advanced Medicine and BJH.

CERVICAL FOLEY + CYTOTEC VS CYTOTEC FOR CERVICAL RIPENING AND LABOR INDUCTION
PI: Jeanine Carbone, MD • CRNC: Patty Fogertey, RN, MSN
A randomized controlled clinical trial to compare the efficacy of the combination of the cervical foley bulb and cervical misoprostol (Cytotec) to cervical misoprostol (Cytotec) alone for cervical ripening and induction of labor. A total of 122 patients with Bishop’s scores of = 6 (unfavorable cervix) requiring induction of labor will be enrolled.

DIABETES STUDY
PI: Alison Cahill, MD, MSCI • CRNC: Danielle Frueh, RN, BSN  - Sponsored by a Thrasher Grant
A prospective study aimed at assessing optimal predictors of fetal macrosomia, birth trauma, or combined neonatal morbidity outcomes in diabetic pregnant women. Recruitment occurs in the antepartum clinic, BJH and CAM. A total of 340 pregnant women will be enrolled over a four-year period.

EFFECT OF HYPOTHERMIA ON NEUTROPHINS IN NEWBORN INFANTS WITH ENCEPHALOPATHY
PI: Rakesh Rao, MD
This is a sub-study of the Women and Infant’s Health Specimen Consortium study. Neurotrophins (NTs), particularly brain derived neurotrophic factor (BDNF) are trophic factors important in brain growth and development. BDNF has been shown to be neuroprotective in various forms of brain injury. This study is aimed at evaluating the change in BDNF and other NT’s in newborn infants with encephalopathy particularly infants with hypoxic ischemic encephalopathy (HIE) after birth. Approximately 20 specimens will be collected through the WIHSC.

GESTATIONAL WEIGHT GAIN IN THE OBESE GRAVIDA
PI: Lorie Harper, MD • CRNC: Patty Fogertey, RN, MSN
A prospective cohort study enrolling 245 women prior to 20 weeks gestation who have pre-pregnant BMI’s > 30. The aim of the study is to examine the impact of gestational weight gain on maternal and neonatal pregnancy outcomes. We will also investigate the relationship between serum biomarkers of adiposity and pregnancy outcomes. Patients will be enrolled through the WIHSC.

INTRAUTERINE GROWTH RETARDATION AND METABOLOMIC PROFILES
PI: Marwan Shinawi, MD
This is a sub-study of the Women and Infant’s Health Specimen Consortium Study aimed at analyzing maternal serum metabolomic fingerprints and correlate them with fetal and newborn metabolomes. Although not a direct aim of this study, the feto-maternal metabolomic data can be correlated in long-term studies with developmental delays, cognitive disabilities, and behavioral abnormalities. The study will collect blood, urine, amniotic fluid, and umbilical cord blood from approximately 150 women with normal pregnancies and 30-50 women with fetal IUGR through the WIHSC.

INTRAUTERINE GROWTH RESTRICTION STUDY
PI: Anthony Odibo, MD, MSCE • CRNC: Linda Odibo, RN, BSc, MN
A prospective cohort study aimed at comparing the ability of two antepartum tests, (Doppler flow studies of feto-placental vessels and biophysical profile), to optimally determine the timing of delivery of preterm intrauterine growth-restriction pregnancies. Recruitment occurs in the Obstetric Ultrasound department, BJH and the Center for Advanced Medicine. A total of 318 pregnant women will be enrolled.

MAGNETIC RESONANCE IMAGING AND SPECTROSCOPY OF THE HUMAN PLACENTA IN VIVO
PI: Michael Nelson, MD, PhD
The study aim is to optimize the magnetic resonance (MR) protocols for scanning human placentas in vivo in order to gain experience in studying human placental anatomy and metabolism using (MRI) and (MRS). Recent data indicate that fetal growth disorders are often better delineated as a result of MRI and MRS studies. Recruitment will occur from pregnant subjects who will undergo an MRI at Barnes Jewish Hospital. The aim is to recruit up to 65 women.

METABOLIC CONDITIONS AND PREGNANCY
PI: Marwan Shinawi, MD
This is a sub-study of the Women and Infant’s Health Specimen Consortium Study aimed at analyzing the newborn metabolomes and correlate this with maternal serum metabolomic fingerprints in health and diseases (IUGR and metabolic conditions). Approximately 200 subjects will be collected through the WIHSC and the Predicting Adverse Pregnancy Outcomes study.

OCCULT INFECTIONS AND PRETERM DELIVERY
PI: Indira Mysorekar, PhD • RT: Rebecca Gunkel • RA: Bridget Conlon, Michele Landeau  - Sponsored by Burroughs Wellcome
A prospective study aimed at determining which pathogenic bacteria are present as occult, intracellular reservoirs in endometrial/placental tissues in women with preterm birth and to evaluate whether pre-existing infection disrupts placental development. Recruitment will occur on Labor and Delivery at BJH through the WIHSC.

PANORAMA: PREDICITING NEONATAL ACIDEMIA AND NEUROLOGIC INJURY WITH INTRAPARTUM FETAL HEART RATE MONITORING

PI: Alison Cahill, MD, MSCI • CRNC: Monica Anderson, RN, BSN; Carla Chung, RN, BSN; Danielle Frueh, RN, BSN; Tracy Burger RN, BSN  - Sponsored by a NIH/NICHD RO1 grant
A prospective study aimed at determining which fetal heart rate deceleration characteristics, are associated with an infant umbilical cord arterial pH = 7.10. The study also aims to develop and validate a clinical predictive index to identify specific fetuses at high risk for acidemia based on characteristics of EFM recordings. Recruitment will occur at Barnes-Jewish Hospital with a total of 7,150 mothers and 200 babies over a five-year period.

PLACENTAL FUNCTION STUDY
PI: Methodius Tuuli, MD, MPH • CRNC: Linda Odibo, RN, BSc, MN
This is a prospective cohort study of pregnant women between 18-22 weeks gestation who are undergoing their second trimester fetal anatomy scan. The study aims to determine if a single parameter of placental structure, blood flow, or analyte secretion in the second trimester predicts sub-optimal pregnancy outcome and to determine if combination of first trimester and second trimester placental assessment and analyte secretion improve the predicative value of the model to predict adverse pregnancy outcome. A total of 1,500 women will be recruited from the Obstetric Ultrasound department, and the CAM.

POLYMICROBIAL SYNERGISM IN ADVERSE PREGNANCY OUTCOMES
PIs: Anthony Shanks, MD, Amanda Lewis, PhD, Jenifer Allsworth, PhD
This is a longitudinal study in order to examine whether combinations of bacterial inhabitants in the reproductive and urinary tracts are associated with higher risks of adverse pregnancy outcomes. Urine and vaginal swabs collected during prenatal visits will be obtained through the WIHSC.

PREDICTING ADVERSE PREGNANCY OUTCOMES
PI: Anthony Odibo, MD, MSCE • CRNC: Linda Odibo, RN, BSc, MN
This is a prospective cohort study of pregnant women between 11-14 weeks gestation undergoing their first trimester aneuploidy scan. The aim of the study is to determine if a single parameter of placental structure, blood flow, or analyte secretion predicts sub-optimal pregnancy outcome. The study includes doppler evaluation of uterine arteries, assessment of placental volume, maternal serum for free beta-hCG and PAPP-A, with the addition of ADAM12s , PP13 and PIGF levels. A total of 1,500 women will be recruited from the Obstetric Ultrasound Department, Center for Advanced Medicine over a three year period.

THE ROLE AND REGULATION OF MAXI-K CHANNELS DURING PREGNANCY
PI: Sarah England, PhD - Sponsored by an NIH grant
This is a prospective study looking at the control of muscle contractions of the uterus during labor by looking at channel proteins in the uterine muscle. These channel proteins are involved in muscle functions. Approximately 1000 women will be recruited from Barnes Jewish Hospital who are undergoing cesarean delivery or hysterectomy.

SLEEP DEPRIVATION DRING PREGNANCY
PI: George Macones, MD, MSCE, Jen Jen Chang, PhD • RA: Molly Meyer
A longitudinal prospective cohort study to ascertain the prevalence and risk factors of chronic sleep deprivation during pregnancy and its effects on postpartum depression and spontaneous preterm delivery. A total of 356 nulliparous women will be recruited from the antenatal clinic in BJC and the Center for Advance Medicine over a three-year period.

TUPAC: TREATMENT UTILITY OF POSTPARTUM ANTIBIOTICS IN CHORIOAMNIONITIS
PI: Anthony Shanks, MD • CRNC: Patty Fogertey, RN, MSN
A randomized controlled clinical trial to determine if prophylactic antibiotics are required post-cesarean delivery for pregnancies with treated chorioamnionitis. Enrollment is 398 laboring patients with chorioamnionitis who require delivery via cesarean section.

THE ST. LOUIS NEONATAL GUT MICROBIOME INITIATIVE
PI: Barbara Warner, MD • CRC: Christine Kramer - Sponsored by the Children’s Discovery Institute of St. Louis Children’s Hospital
A twin birth cohort study aimed at testing the relative roles of host genotype versus early environmental exposures (mother, diet, etc) on gut microbial ecology. This will compare how similar the microbial community is for identical twins to non-identical twins in the first year of life. Recruitment will occur at the CAM, Labor and Delivery at BJC, and Missouri Baptist Hospital. The study aims to enroll 100 mothers and 25 monozygotic twin pregnancies over 34-weeks gestation.

VDAART: VITAMIN D ANTENATAL ASTHMA REDUCTION TRIAL
PI: Robert Strunk, MD • CRNC: Danae Larson, RN, BSN • RA: Jennifer Byers, Yvonne Burrage - Sponsored by a NIH Grant
A multi-centered randomized double blind controlled trial to determine whether sufficient vitamin D supplementation in the pregnant mother is associated with reduced incidence of asthma in the child during the first three-years of life. Our primary outcomes will be doctor’s diagnosis of asthma and/or recurrent wheeze in the child at age three-years. A total of 290 patients at Washington University will be recruited over two years.

WIHSC: WOMEN AND INFANT'S HEALTH SPECIMEN CONSORTIUM
PI: Ann Gronowski, PhD; Kelle Moley, MD; Jenifer Allsworth, PhD; Marwan Shinawi, MD • CRC: Christine Kramer • RAs: Lyndsay Roy, Kim Townsend, Bridget Conlon, Michele Landeau - Sponsored by a Children's Discovery Institute Grant
The study aim is to create a structure to facilitate the collection of patient specimens for women and infant's health research. The bank will provide specimen collection, specimen storage and processing, as well as the maintenance of a comprehensive database of outcomes data for five hypothesis driven projects. This process will be completed by working together with the LTP (Laboratory Translational Pathology). Recruitment will occur at Washington University Reproductive Endocrinology and Infertility Center,the Center for Advanced Medicine, Barnes Jewish Women’s Health Clinic and Labor and Delivery. Approximately 2000 women and 350 infants will be enrolled.