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17-PRIME: 17-HYDROXYPROGESTERONE CAPROATE FOR PRETERM BIRTH PREVENTION: ASSOCIATION BETWEEN ITS METABOLITES AND EFFICACY

PI: Molly Stout, MD • CRNC: Kristin Sheldon, RN, BSN - Sponsored by Lumara Health

To test the hypothesis that specific metabolic products of the drug 17OHPC can be associated with success or failure of 17POHPC preterm birth prevention. Specifically we aim to examine both the maternal metabolites, and the fetal metabolites of 17OHPC as the fetus is known to participate in the signal for the onset of parturition.

CHAP: ANTIHYPERTENSIVE THERAPY FOR MILD CHRONIC HYPERTENSION DURING PREGNANCY

PI: Methodius Tuuli, MD • CRNC: Shannon Martin, RN, BSN

A Multicenter Randomized Trial. Antihypertensive therapy to a standardized BP goal <140/90, compared with ACOG recommendations (no treatment), for mild CHTN reduces the frequency of key adverse maternal and newborn outcomes associated with CHTN including 1) a composite perinatal outcome (perinatal death, placental abruption, severe preeclampsia or indicated PTB <35 weeks) and 2) SGA (birth weight <10th percentile). The purpose of this study is to evaluate whether a BP treatment strategy to achieve targets that are beneficial for non-pregnant adults (<140/90 mmHg) is safe and effective during pregnancy.

GDM: EARLY COMPARED WITH ROUTINE POSTPARTUM SCREENING AFTER GESTATIONAL DIABETES

PI: Methodius Tuuli, MD ? CRNC; Shannon Martin, RN, BSN

To determine if early postpartum screening in women with Gestational Diabetes can provide the same results as screening at 6-12 weeks postpartum. The ability to detect any issues earlier would allow women who are high risk the benefit of receiving earlier care.

GDM GROUP: GROUP VERSUS TRADITIONAL PRENATAL CARE FOR DIABETES: A RANDOMIZED CONTROLLED TRIAL

PI: Ebony Carter, MD • RC: Krystal Kan - Sponsored by CDTR funding

A randomized trial to test group prenatal care on self-care activities, compared to traditional prenatal care, will improve glycemic control and, ultimately, maternal and neonatal outcomes in women with type 2 and gestational diabetes.

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.

OMSS: OPTIMIZING MANAGEMENT OF THE SECOND STAGE OF LABOR: A MULTICENTER TRIAL

PI: Alison Cahill, MD & Methodius Tuuli • CRNC: Carla Chung, RN, BSN, Tracy Burger, RN, BSN • RC: Mirela Grabic, Alanna Hooper, Hillary Keveney, Jaclyn Schipper - Sponsored by a NIH grant

This is a multicenter randomized trial of nulliparous women to compare the effectiveness of immediate and delayed pushing in the second stage of labor. We aim to test the central hypothesis that immediate pushing in the second stage of labor increases spontaneous vaginal delivery, shortens duration of the second stage, and reduces adverse neonatal and maternal outcomes. Secondary aim is to determine the effect of immediate pushing on the rate of neonatal composite morbidity and determine the impact of immediate versus delayed pushing on objective and subjective measures of maternal pelvic floor morbidity. Enrollment is 3184 laboring patients.

PALS: VAGINAL PROGESTERONE FOR THE PREVENTION OF PRETERM BIRTH IN WOMEN WITH ARRESTED LABOR

PI: Molly Stout, MD • CRNC: Tracy Burger, RN, BSN; Shannon Martin, RN, BSN • RC: Krystal Kan

Randomized, double-blinded, placebo controlled trial. Women enrolled in the study will be randomized to vaginal administration of micronized progesterone 200 mg or placebo daily from time of enrollment until 36 6/7 weeks gestation. Investigators, participants, and the obstetric providers will be blinded to the allocated intervention.

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

PI: Alison Cahill, MD, MSCI • CRNC: Carla Chung, 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.

PICO: PROPHYLACTIC NEGATIVE PRESSURE WOUND THERAPY IN OBESE WOMEN AFTER CESAREAN: A PILOT RANDOMIZED TRIAL

PI: Methodius Tuuli, MD • CRNC: Shannon Martin, RN, BSN; Kristin Sheldon, RN, BSN

A randomized trial to determine the effectiveness of prophylactic Negative Pressure Wound Therapy (NPWT) in reducing the rate of surgical site infections (SSIs) after cesarean in obese women. Assess the safety of prophylactic NPWT in obese women as measured by frequency of adverse events including skin blisters, erythema, wound bleeding, and prolonged wound drainage. Determine the effect of prophylactic NPWT on the frequency and identity of bacteria, including antibiotic-resistant organisms, isolated from SSIs after cesarean in obese women.

PPCM: IDENTIFYING THE GENETIC UNDERPINNINGS OF PERIPARTUM CARDIOMYOPATHY

PI: George Macones, MD • CRNC: Shannon Martin, RN, BSN- Sponsored by SPIRit

Peripartum Cardiomyopathy (PPCM) is a rare disease (1:1000 births) that causes profound heart failure in the peripartum period, leaving otherwise healthy young women and their infants devastated. Its cause remains elusive. They propose to acquire DNA samples form a number of national and international centers. The samples will be used to carry out exome sequencing, in order to identify rare variants that predisposed to PPCM. Samples will be sent de-identified. Sequencing and bioinformatics analysis will be done.

PPHTN: FUROSEMIDE FOR PREVENTION OF SEVERE POSTPARTUM HYPERTENSION: A RANDOMIZED CONTROLLED TRIAL

PI: Methodius Tuuli, MD • CI: Jennifer Durst, MD; Kathryn Lindley, MD • CRNC: Shannon Martin, RN, BSN; RC: Courtney Olson; Krystal Kan

A randomized controlled trial to test the efficacy and safety of postpartum furosemide for preventing severe postpartum hypertension in women with Gestational Hypertension or PreEclampsia. Our central hypothesis is that prophylactic postpartum furosemide, by promoting excretion of excess fluid and sodium, will reduce severe postpartum hypertension in high-risk women.

PRESERVE-1: PROSPECTIVE RANDOMIZED DOUBLE-BLIND, PLACEBO CONTROLLED EVALUATION OF PHARMACOKINETICS, SAFETY AND EFFICACY OF RECOMBINANT ANTITHROMBIN VERSUS PLACEBO IN PRETERM PRECLAMPSIA

PI: George Macones, MD • CRNC: Shannon Martin, RN, BSN; Kristin Sheldon, RN, BSN - Sponsored by a rEVO Biologics

This study is a prospective, randomized, double-blind, placebo-controlled evaluation of the safety, efficacy, and PK of rhAT in pregnant women with preterm preeclampsia (PPE). Efficacy will be assessed by comparing the difference in extension of gestational age from the time of randomization into the study until delivery between rhAT and placebo treated subjects. In addition, the effect of rhAT on fetal and neonatal clinical outcomes will be assessed. The PK characteristics of rhAT in the subjects will be investigated by measuring AT activity levels in the mother during treatment and in cord blood.

THE MARCH OF DIMES PREMATURITY RESEARCH CENTER AT WASHINGTON UNIVERSITY

PI: George Macones, MD • PM: Jessica Chubiz • CRNC: Melisa Beardslee, RN, BSN • RC: Christine Kramer, Dina Kaissi - Sponsored by March of Dimes

The March of Dimes Prematurity Research Center at Washington University in St. Louis was launched in November 2014. With a generous $10 million in funding from March of Dimes over 5 years, this virtual research center brings together investigators across disciplines at Wash U, with the goal of finding the causes and predictors of preterm births. This transdisciplinary approach to prematurity research is led by Center Director George Macones, MD, MSCE, Chair of OB/GYN, and by Associate Directors Alan Schwartz, MD, PhD, Chair of Pediatrics and Sarah England, PhD, Professor of OB/GYN.

THE ROLE AND REGULATION OF MAXI-K CHANNELS DURING PREGNANCY

PI: Sarah England, PhD • CRNC: Shannon Martin, RN, BSN- 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.

VAGINAL PREP: VAGINAL CLEANSING BEFORE CESAREAN DELIVERY TO REDUCE INFECTION: A RANDOMIZED TRIAL

PI: Lorene Temming, MD • CRNC: Shannon Martin, RN, BSN • RC: Courtney Olson

A randomized trial to compare the standard-of-care preoperative abdominal cleansing to abdominal cleansing plus vaginal cleansing with povidone-iodine solution prior to cesarean delivery of women in labor. To attempt to provide this Level 1 evidence by performing a clinical trial to test the central hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

WIHSC: WOMEN AND INFANT'S HEALTH SPECIMEN CONSORTIUM

PI: Ann Gronowski, PhD; Kelle Moley, MD; • RC: Christine Kramer, Michele Landeau, and Dina Kaissi

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. 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 2800 women and 1022 infants will be enrolled.