![Page 1: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/1.jpg)
Cynthia Gyamfi-Bannerman, MD, MSc
Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN
Principal Investigator, MFMU Network—Columbia
Co-Director, Preterm Birth Prevention Center
![Page 2: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/2.jpg)
• Unrestricted grant from SMFM/AMAG for prematurity research
• Attended NY Sera Advisory Board Meeting
![Page 3: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/3.jpg)
• Obstetrical management, especially for high-risk patient, had often adopted practices without objective evaluation
• To address the need for well-designed clinical trials in maternal fetal medicine, the NICHD established the MFMU Network in 1986
![Page 4: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/4.jpg)
• The MFMU Network conducts clinical studies to improve maternal, fetal and neonatal health with greatest priority given to randomized trials
• The aim is to: – Reduce morbidity to mom and baby, related to
preterm birth, fetal growth abnormalities & maternal complications
– Provide rationale for evidence-based, cost-effective, obstetric practice
![Page 5: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/5.jpg)
Brown University
Case Western Reserve University
Columbia University
Northwestern University
The Ohio State University
University of Alabama — Birmingham
University of North Carolina — Chapel Hill
University of Pennsylvania
University of Pittsburgh
University of Utah
University of Texas — Galveston
University of Texas — Houston
![Page 6: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/6.jpg)
Brown University
Case Western Reserve University
Columbia University
Northwestern University
The Ohio State University
University of Alabama — Birmingham
University of North Carolina — Chapel Hill
University of Pennsylvania
University of Pittsburgh
University of Utah
University of Texas — Galveston
University of Texas — Houston
Dwight Rouse
Edward Chien
Cynthia Gyamfi-Bannerman
Bill Grobman
Mark Landon
Alan Tita
John Thorpe
Sam Perry
Hy Simhan
Michael Varner
George Saade
Suneet Chauhan
![Page 7: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/7.jpg)
• Centers participate collaboratively in common protocols
• Racial/ethnic, geographic diversity
• Conducts mainly randomized trials, but also observational studies
• Co-funding by other NIH institutes
• Complex studies- require IND/IDE/multidisciplinary
• Only Federally funded obstetric research network
RFA ISSUED EVERY FIVE YEARS
![Page 8: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/8.jpg)
• Academic productivity - clinical trials
• Minimum of 3,000 deliveries per year with a minimum of 30% documented to be high-risk pregnancies
• 4 board-certified MFMs with clinical, academic, administrative and research commitments
• Available population for clinical studies
![Page 9: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/9.jpg)
• Facilities and clinical capabilities• Follow-up Program up to 5 years of age-
Neonatology/Pediatric subspecialists• Imaging and assessment techniques,
proteomics, genomics, microanalysis, placental function assessment, clinical pharmacology
• Perinatal data system• Departmental and institutional commitment• Acceptance of budgetary mechanism
![Page 10: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/10.jpg)
Steering Committee Center PIs
Data Coordinating Center PINICHD Project Scientist
Data Coordinating
Center
NICHD
Advisory BoardMFM
NeonatologyBiostatistics
Ad hoc
Data & Safety Monitoring Committee
MFM EthicsNeonatology Biostatistics
Obstetrics Lay person
![Page 11: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/11.jpg)
• Principal Investigator (PI)
• Alternate PI
• Other investigators
• Research nurse coordinator
• Research nurses / staff
• Data entry clerk Academic
MFMcenters
![Page 12: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/12.jpg)
• Columbia Center:
– Columbia and Allen
– Christiana
– Drexel
– St. Peter’s
– NY Hospital Queens
• Columbia Center staff:
– PI: Gyamfi
– Alt PI: Wapner
– Nurse Coordinator: Bousleiman
– PI and site coordinator for each of the 5 sites
![Page 13: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/13.jpg)
Cynthia Gyamfi-Bannerman, MD
Principal Investigator
Ronald Wapner, MD
Alternate Principal Investigator
MFM Faculty/Study
Site PI - CUMC
Lauren Plante, MD
Site PI - Drexel
Cheryl Tocci
Site Coordinator- Drexel
MFMU Research Staff
Matthew Hoffman, MD
Site PI - CCHS
Carrie Kitto
Site Coordinator-CCHS
MFMU Research Staff
Kristy Palomares, MD
Site PI- SPUH
Shoan Davis
Site Coordinator- SPUH
MFMU Research Staff
Daniel Skupski, MD
Site PI- NYPQ
Rosalyn Chan-
Site Coordinator – NYPQ
MFMU Research Staff
Michelle DiVito
Administrative Director of Research
Sabine Bousleiman
MFMU Nurse Coordinator
Mary Talucci
QA Coordinator
Vilmarie Carmona
Site Coordinator- CUMC
MFMU –Research Staff
![Page 14: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/14.jpg)
Dark color-Recruitment periodLight color-Follow-up period
36 RCTs
23 Observational studies
12 Major Ancillary Studies
![Page 15: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/15.jpg)
• 340 MFMU Publications to date
• 15 MFMU Publications in 2018
• 19 NEJM
• 92 OBGYN
• 120 AJOG
• 34 AJP
![Page 16: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/16.jpg)
• Concept
– 2/3 vote to be approved to move to next step
• Mini-protocol
– Simple majority to move to next step
• Full protocol
– Simple majority to move to next step
• External Advisory Board Review
• Prioritization
![Page 17: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/17.jpg)
![Page 18: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/18.jpg)
![Page 19: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/19.jpg)
![Page 20: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/20.jpg)
• Prevent Congenital Cytomegalovirus Infection
(CMV)– In follow-up phase
• Hepatitis C Virus Child to Mother Transmission
(HCV)
• Pessary and Progesterone for Preterm Prevention in
Twin Gestation with a Short Cervix (PROSPECT)
• Pessary in Singleton Pregnancies with a Short Cervix (TOPS)
![Page 21: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/21.jpg)
• ALPS pulmonary follow-up in offspring– Co-funded by NHLBI (Dr. Aruna Natarajan)
• ALPS neurologic follow-up in offspring
• Sleep Apnea Treatment in Pregnancy to Reduce Frequency of Hypertensive Disorders of Pregnancy– Co-funded by NHLBI (Dr. Aaron Laposky)
• Tranexamic Acid for the Prevention of Obstetrical Hemorrhage after Cesarean Delivery
![Page 22: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/22.jpg)
• Beneficial Effects of Antenatal Magnesium Sulfate (BEAM)• Beneficial Effects of Antenatal Corticosteroid Regimens (BEARS)• Cesarean Section and Vaginal Birth After Cesarean Section Registry• Mid-Trimester Endovaginal Sonography in Women at High Risk for
Spontaneous Preterm Delivery• Observational Study of Women with Factor V Leiden Mutation in
Pregnancy• High-Dose Aspirin to Prevent Preeclampsia in High-Risk Women• Low-Dose Aspirin as a Preventative of Preeclampsia• Obstetrical Determinants of Neonatal Survival Registry• Screening for Risk Factors for Spontaneous Preterm Delivery in
Singletons and Twins• 17-OHPC for Prevention of Preterm Birth in Multifetal Gestation
![Page 23: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/23.jpg)
• Contact the Biostatistical Coordinating Center
– PI is Elizabeth Thom, PhD
• Request access to data
• Can also request access to biospecimens
![Page 24: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/24.jpg)
• GDM F/u study– Both women and children
• Short cervix and nulliparous women
• CAPPS
• BEAM (Beneficial Effects of Mag Sulfate)
• BEARS (Beneficial Effects of Antenatal Repeat Steroids)
• STTARS—17-OHPC for twins and triplets
• Omega 3
• Factor V Leiden
• Progesterone (Meis)
![Page 25: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/25.jpg)
![Page 26: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/26.jpg)
Global Alliance to Prevent Prematurity and Stillbirth
• $20 million program funded by the Bill & Melinda Gates Foundation
• Global
• Preventing Preterm Birth (PPB)
– PPB 1: FINDING NEW SOLUTIONS (TRANSLATIONAL)
– PPB 2: INTERNATIONAL RESEARCH SITES
– PPB 3: SYSTEMS BIOLOGY APPROACH
![Page 27: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/27.jpg)
Prematurity Research Centers (6)
• Stanford
• University of Pennsylvania
• Ohio Collaborative
• Washington University in St. Louis
• U. Chicago/Northwestern/Duke
• Imperial College London
![Page 28: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/28.jpg)
MOD Database for Preterm Birth Research
• contains information from 15 molecular studies, with aggregated genetic data from almost 25,000 patients, and molecular measurements on more than 8,000 samples
• Announced last month
• http://www.immport.org/resources/mod
![Page 29: Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine ... · Cynthia Gyamfi-Bannerman, MD, MSc Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN Principal Investigator,](https://reader036.vdocuments.net/reader036/viewer/2022071216/60484bb6bba3f10c9f15af0d/html5/thumbnails/29.jpg)
Cynthia Gyamfi-Bannerman, MD, MSc
Ellen Jacobson Levine and Eugene Jacobson Professor of OBGYN
Principal Investigator, MFMU Network—Columbia
Co-Director, Preterm Birth Prevention Center