Obstetrics and Gynecology

OBGYN and Pediatrics Research Laboratory

The OBGYN Pediatrics Clinical Research Team, housed in the department of Obstetrics and Gynecology comprises six clinical research coordinators and a research director. The team currently manage and run quite a large number of clinical trials (see Table below) in the departments of OBGYN and Pediatrics. The team support the full range of clinical trials, including investigational drugs, devices, biomarkers, surveys, and quality improvement projects. These may be federally funded, industry supported, or investigator initiated and supported by institutional funds.

The team conduct all phases of a clinical trial and are able to navigate seamlessly between different sponsors, Contract Research Organizations (CROs), and the Institutional Review Board (IRB). All team members are foreign trained physicians; their background medical knowledge proving to be invaluable when developing new protocols and negotiating with sponsors/CROs and Principal Investigators.

A typical work day for the team includes conducting feasibility analyses for new trials, creating standardized workflows for each trial, screening and recruiting study subjects, scheduling and conducting study visits, collecting samples and processing them to be shipped to various labs, collecting and entering data, developing protocols and IRB submissions, and creating and maintaining regulatory binders.

Members of the team work closely with other groups throughout the hospital, such as the IRB, Research Administration, Investigational Drug Services (IDS) in Pharmacy, the hematology and microbiology labs, and with nurses on various clinical units. The diligence and professionalism displayed by the team every day has been critical in securing many clinical trials.

The team also works with the Ob/Gyn residents and MFM fellows to provide training and support, and to help them with their individual research projects. They also mentor medical students from Tufts University School of Medicine. The students either partner directly with a principal investigator and work on a single active project, work on their own research, or work with the team as a whole to learn about clinical research and help support several ongoing research projects.

Department

Currently active Industry trials

Studies in the pipeline

NIH/CDC

PI Initiated

Totals

OBGYN

12

7

11

16

46

Pediatrics

24

12

0

13

49

Totals

36

19

11

29

95

Original research publications

  1. Tarui T, Madan M, Farhat N, Kitano R, Tanritanir A, Graham G, Gagoski B, Craig A, Rollins C, Ortinau C, Iyer V, Pienaar R, Bianchi DW, Grant PE, Im K. Disorganized patterns of sulcal position in fetal brains with agenesis of corpus callosum. Cereb Cortex 2018; 28(9): 3192-3203.
  2. Kalyanaraman R, Demtchouk V, Iyer V, Patterson D. Determining the health state utility value of Urinary tract infection in women. Female Pelvic Med Reconstr Surg 2019;25(2): 185-187.
  3. Mhatre M, Adeli S, Norwitz ER, Craigo S, Phillippe M, Edlow A. The effect of maternal obesity on placental cell-free DNA release in a mouse model. Reprod Sci 2019; in press.
  4. Salvany-Celades M, van der Zwan A, Benner M, Setrajcic-Dragos V, Bougleux Gomes HA, Iyer V, Norwitz ER, Strominger JL, Tilburgs T. Three types of functional regulatory T cells control T cell responses at the human Maternal-Fetal interface. Cell Reports 2019; 27(9):2537-47.e5. doi: 10.1016/j.celrep.2019.04.109.
  5. Norwitz ER, McNeill G, Kalyan A, Rivers E, Ahmed E, Meng L, Vu P, Egbert M, Shapira M, Kobara K, Parmar S, Goel S, Prins SA, Aruh I, Persico N, Robins JC, Kirshon B, Demko ZP, Ryan A, Billings PR, Rabinowitz M, Benn P, Martin KA, Hedriana HL. Validation of a single-nucleotide polymorphism-based non-invasive prenatal test in twin gestations: determination of zygosity, individual fetal sex, and fetal aneuploidy. J Clin Med 2019; 8,937; doi:10.3390/jcm8070937

Selected abstracts and presentations

  1. Shi L, Iyer V, Norwitz ER, Moore Simas TA, Matthan NR, Lichtenstein AH, Hayman LL. A pilot study to assess the feasibility and acceptability of soy foods for pregnant women at high risk for gestational diabetes [Poster]. 37th Annual Meeting of the Society of Behavioral Medicine, Washington DC. April 2016.
  2. Tarui T, Madan N, Farhat N, Kitano R, Tanritanir A, Graham G, Gagoski B, Craig A, Rollins C, Ortinau C, Iyer V, Bianchi D, Grant E, Im K. Disorganized patterns of sulcal position in fetal brains with agenesis of corpus callosum [Poster]. Annual Scientific Meeting of the Child Neurology Society, Vancouver, Canada. October 2016.
  3. Tarui T, Madan N, Farhat N, Kitano R, Tanritanir A, Graham G, Gagoski B, Craig A, Rollins C, Ortinau C, Iyer V, Bianchi D, Grant E, Im K. Disorganized patterns of sulcal position in fetal brains with agenesis of corpus callosum [Poster]. Annual Scientific Meeting of American Academy of Neurology, Boston, MA. April 2017.
  4. Shi L, Iyer V, Norwitz ER, Moore Simas TA, Matthan NR, Lichtenstein AH, Hayman LL. Feasibility, safety and acceptability of soy-based diet for pregnant women: preliminary results from a pilot randomized controlled trial [Poster]. 7th Annual Research Retreat at UMass Center for Clinical and Translational Science, Worcester, MA. May 2017.
  5. Driscoll J, Brazil R, Iyer V, Dangel A. Evaluation of the accessibility of structured exercise programs for pregnant women: an analysis of offerings at the YMCAs of Massachusetts [Poster]. 19th Annual Tufts CTSI Graduate Program Symposium, Boston, MA. May 2017.
  6. Shi L, Iyer V, Norwitz ER, Moore Simas TA, Matthan NR, Lichtenstein AH, Hayman LL. Feasibility, safety and acceptability of soy-based diet for pregnant women: preliminary results from a pilot randomized controlled trial [Poster]. American Heart Association, New Orleans, LA. March 2018.
  7. Driscoll J, Brazil R, Iyer V, Dangel A. Evaluation of the accessibility of structured exercise programs for pregnant women: an analysis of offerings at the YMCAs of Massachusetts [Poster]. 7th Annual Community Engagement and Research Symposium, UMass Medical School, Worcester, MA. March 2018.
  8. Kalyanaraman R, Demtchouk V, Iyer V, Patterson D. Determining the health state utility value of Urinary tract infection in women [Oral]. American Urogynecologic Society (AUGS), Chicago, IL. October 9-13, 2018.
  9. Driscoll J, Brazil R, Iyer V, Dangel A. Evaluation of the accessibility of structured exercise programs for pregnant women: an analysis of offerings at the YMCAs of Massachusetts [Poster]. 43rd Annual Meeting of the New England Perinatal Society (NEPS), Newport, RI. March 1-3, 2019.
  10. Driscoll J, Brazil R, Iyer V, Dangel A. Evaluation of the accessibility of structured exercise programs for pregnant women: an analysis of offerings at the YMCAs of Massachusetts [Poster]. Annual Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG), Nashville, TN. May 3-6, 2019.
  11. Iyer V, Kalyanaraman R, McCormack M, Brazil R, Roncari D. Retrospective cohort study for satisfaction of patients who had undergone Essure vs Tubal Ligation [Poster]. Annual Scientific Meeting of the American College of Obstetricians and Gynecologists (ACOG), Nashville, TN. May 3-6, 2019.
  12. Leung A, Muoser C, Iyer V, Taymoori A, Tighiouart H, Patterson D, Ferzandi T. (Scientific Salon) Knowledge and Perception of Pelvic Floor Disorders Among Asian Women at a Tertiary Care Center versus a Community Health Clinic. American Urogynecologic Society (AUGS), Chicago, IL. October 9-13, 2018.
  13. Goh I, Woo J, Smith C, Drew J, Dennos A, Malla B, Malloy M. Development and evaluation of a research coordinator mentoring/coaching program. Annual Scientific Meeting of the Childhood Arthritis & Rheumatology Research Alliance (CARRA), Louisville, KY. 2019.
  14. Mhatre M, Clifford C, Adalsteinsson V, Lo C, Xiong K, Phillippe M, Iyer V, Taymoori A, Norwitz ER, Craigo S, Edlow A. Maternal obesity and labor status impact cell-free DNA methylation profile of pregnant women at term. 39th Annual Pregnancy Meeting of the Society for Maternal Fetal Medicine (SMFM), Las Vegas, NV. February 11-16, 2019.
  15. Yen E, Tarui TK, Ruthazer R, Harvey-Wikes H, Hassaneen M, Maron JL . Sex-Dependent Gene Expression in Infants with Neonatal Opioid Withdrawal Syndrome .JPeds 2019; DOI: https://doi.org/10.1016/j.jpeds.2019.07.032
  16. Sadr F. Polyhydroamnios. In: Norwitz Errol R, editor. Toronto: Decker Medicine; August 2019. DOI: 10.2310/7900.19174.