Research
 

PRC Participation in National Institutes of Health (NIH) Projects

Currently Enrolling

  • Pregnancy Loss Study (LosSEQ) (Sponsored by NICHD)
  • Chronic Hypertension and Pregnancy Maternal Follow-Up Study (Sponsored by NIH/NHLBI)
  • Modeling informatics data to track maternal risk and care quality (Sponsored by NICHD)

Completed

  • Chronic Hypertension and Pregnancy (CHAP) Project (Sponsored by NIH/NICHD)
  • Medical Optimization and Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD)
  • “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)
  • EASE Study: A randomized, controlled study to evaluate the safety and effectiveness of the Materna Prep Device to pre-stretch (i.e., dilate) the vaginal canal and pelvic floor muscles in preparation for vaginal delivery (Sponsored by Materna Medical, Inc)
  • A prospective, natural history study to assess the occurrence of HPA-1a alloimmunization in women identified at higher risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FNAIT) (Sponsored by Rallybio)
  • Development and Validation of Parallel Aneuploidy and Recessive Surveillance
    via Noninvasive Prenatal Screening (parsNIPS) (Sponsored by Myriad Genetics, Inc)

Completed

  • 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)
  • Technology Development for Noninvasive Prenatal Genetic Diagnosis using Maternal Peripheral Blood (Sponsored by Luna Genetics)
  • 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

  • Cardiac strain analysis in monochorionic diamniotic twin pregnancies affected by
    fetal restriction (Partially funded by the PRC for Yale University)

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

 

PRC Publications

A description of the methods of the Nulliparous Pregnancy Outcomes Study: monitoring mothers-to-be

NuMoM2b Sleep-Disordered Breathing study: objectives and methods

Ultrasound Measurement of the Fetal Adrenal Gland as a Predictor of Spontaneous Preterm Birth

Association Between Sleep-Disordered Breathing and Hypertensive Disorders of Pregnancy and Gestational Diabetes Mellitus

Psychometric properties of stress and anxiety measures among nulliparous women

  • nuMoM2b Heart Health Study:

Pregnancy as a Window to Future Cardiovascular Health: Design and Implementation of the nuMoM2b Heart Health Study

  • Fetal Growth Studies:

Racial/ethnic standards for fetal growth: the NICHD Fetal Growth Studies

Maternal stress and neonatal anthropometry: the NICHD Fetal Growth Studies

SMFM 2015 Poster presentation:  Cultural differences affecting recruitment in the NICHD Fetal Growth Studies.

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