Research
 

PRC Participation in National Institutes of Health (NIH) Projects

Currently Enrolling

  • Chronic Hypertension and Pregnancy (CHAP) Project (Sponsored by NIH/NICHD)
  • Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD)

Completed

  • “The nuMoM2b Heart Health Study” (Sponsored by NIH/NICHD)
  • “Beta-2 adrenoceptor genotype and the incidence and response to beta-2 against treatment of preterm labor” (BAR)
  • “The Fetal Adrenal Gland as a Predictor of Spontaneous Preterm Birth”
  • “The Fetal Growth Study”
  • “The Nulliparous Network” (nuMoM2b)
  • “Prenatal Determinants of Telomere Length at Birth”

All projects sponsored by NICHD unless otherwise noted

PRC Participation in Industry Projects

Currently Enrolling

  • Advia Centaur Systems Preeclampsia Assays OUS Clinical Trial Specimen Collection Protocol (Sponsored by Siemens Healthcare Diagnostics, Inc)
  • A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of a Respiratory Syncytial Virus (RSV) Prefusion F Subunit Vaccine in Infants born to Women Vaccinated During Pregnancy (The Matisse Study) (Sponsored by Pfizer, Inc)

Completed

  • The PEARLE Study: Prospective, Single Arm, Pivotal Clinical Trial Designed to Assess the Safety and Effectiveness of the Jada System In Treating Primary Postpartum Hemorrhage (Sponsored by Alydia Health, Inc)
  • Clinical Evaluation of the GestAssured test Kit (Sponsored by GestVision, Inc)
  • Prospective Collection of Whole Blood Specimens From Pregnant Women at Any Risk of Fetal Chromosomal Anomaly for the Development of a Noninvasive Prenatal Test (Sponsored by Illumina, Inc)
  • Prospective Collection of Whole Blood Specimens in Pregnant Women (Sponsored by Illumina, Inc)
  • Collection of Whole Blood Samples for the Evaluation of Preeclampsia (PRE-E) Biomarkers from Pregnant Women (PRO-129) (Sponsored by Progenity, Inc)
  • Whole Blood Specimen Collection from Pregnant Subjects (PRO-101) (Sponsored by Progenity, Inc.)
  • The EXPEDITE Study: “Efficacy and Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert for Reducing Time to Vaginal Delivery” (Sponsored by Cytokine PharmaSciences, Inc.)
  • “Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy” (Sponsored by Tandem Diagnostics)
  • “Maternal Blood IS Source to Accurately diagnose fetal aneuploidy” (MELISSA) (Sponsored by Artemis Health, Inc.)
  • “Prospective Collection of Whole Blood Specimens of Subjects Diagnosed with Preeclampsia with Severe Features and/or Fetal Growth Restriction in Support of a Molecular Assay Development” (Sponsored by Illumina, Inc.)
  • “The Safety, Tolerability and Metabolism of GSK221149A, In Pregnant Women (30-36 Weeks), In Preterm Labor” study (Sponsored by GlaxoSmithKline)

Investigator Initiated

Currently Enrolling

  • A Re-evaluation of Traditional Post-partum Hemorrhage Risk Factors

Completed

  • Maternal Plasma Exosome Testing to Detect Fetal Brain Injury Following CMV or Zika Infection
  • Does the Cerebroplacental Ratio (CPR) Predict Adverse Outcomes in Low Risk Pregnancies? (CPR study) (Unfunded)
  • “Do infants born to mothers with intrahepatic cholestasis of pregnancy have increased PR interval?” (Unfunded)
  • “Morbidly Adherent Placenta: A Pilot Retrospective Cohort Study” (MAP Study) (Unfunded)
  • “A Multi-Center Study Investigating the Factors that Influence Female Participation in Clinical Research” (Unfunded)
  • Rare Disease Registry (Sponsored by CTSAs at Columbia University, University of North Carolina, University of Utah, University of Texas Medical Branch and the University of Alabama)

 

PRC Participation in MFMU Network Projects

Current Projects

  • “A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix” (PROSPECT)
  • “A Randomized Trial of Pessary in Singleton Pregnancies with a Short Cervix” (TOPS)
  • “An Observational Study of Hepatitis C Virus in Pregnancy” (HCV)
  • “Congenital Cytomegalovirus Infection: Randomized Placebo-Controlled Trial” (CMV)
  • “Childhood Cognitive Function in a Birth Cohort after a Randomized Trial of Antenatal Corticosteroids:  the ALPS Neurocognitive Follow-Up Study” (ALPS Neuro)
  • “Childhood Pulmonary Complications in a Birth Cohort after a Randomized Trial of Antenatal Corticosteroids: the ALPS Follow-Up Study” (ALPS FSP)
  • “A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy” (SLEEP)
  • “Activity in Women at Risk for Early Delivery” (AWARE-An Ancillary Study)
  • “A Randomized Controlled Trial of Pravastatin to Prevent Preeclampsia in High Risk Women” (Pravastatin)

All Sponsored by NICHD

 

 

Completed Projects

  • “Antenatal Late Preterm: Randomized Placebo-Controlled Trial” (ALPS)
  • “Combined Antioxidant and Preeclampsia Prediction Studies” (CAPPS)
  • Induction in Nulliparous Women at 39 weeks to Prevent Adverse Outcomes: A Randomized Controlled Trial” (ARRIVE)
  • “Mild GDM Management and Long Term Maternal and Child Health: Follow-up of the Mild GDM Trial” (GDM-FU)
  • “An Observational Cohort Study to Evaluate Measures of Quality of Obstetric Care” (APEX)
  • “Randomized Clinical Trial of Omega-3 Supplementation To Prevent Preterm Birth” (Omega-3)
  • “A Randomized Study of Seventeen Alpha-Hydroxyprogesterone Caproate in Twins and Triplets” (STTARS)
  • “A Randomized Trial of 17P for Prevention of Preterm Birth in Nulliparous Women with a Short Cervix” (SCAN)
  • “A Randomized Trial of Fetal ECG ST Segment and T Wave Analysis as an Adjunct to Electronic Fetal Heart Rate Monitoring” (STAN)
  • “A Randomized Trial of Thyroxine Therapy for Subclinical Hypothyroidism or Hypothyroxinemia Diagnosed During Pregnancy” (TSH)
  • “A Randomized Trial of Treatment for Mild Gestational Diabetes Mellitus” (GDM)
  • “A Registry Study of Novel Swine-Origin H1N1 Influenza A Virus Among Hospitalized Pregnant and Immediately Postpartum Women” (H1N1)
  • “Translating Research into Practice in Obstetrics” (TRIO Survey)

All Sponsored by NICHD