cynthia gyamfi-bannerman, md, msc ellen jacobson levine ... · cynthia gyamfi-bannerman, md, msc...

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

• Unrestricted grant from SMFM/AMAG for prematurity research

• Attended NY Sera Advisory Board Meeting

• 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

• 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

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

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

• 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

• 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

• 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

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

• Principal Investigator (PI)

• Alternate PI

• Other investigators

• Research nurse coordinator

• Research nurses / staff

• Data entry clerk Academic

MFMcenters

• 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

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

Dark color-Recruitment periodLight color-Follow-up period

36 RCTs

23 Observational studies

12 Major Ancillary Studies

• 340 MFMU Publications to date

• 15 MFMU Publications in 2018

• 19 NEJM

• 92 OBGYN

• 120 AJOG

• 34 AJP

• 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

• 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)

• 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

• 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

• Contact the Biostatistical Coordinating Center

– PI is Elizabeth Thom, PhD

• Request access to data

• Can also request access to biospecimens

• 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)

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

Prematurity Research Centers (6)

• Stanford

• University of Pennsylvania

• Ohio Collaborative

• Washington University in St. Louis

• U. Chicago/Northwestern/Duke

• Imperial College London

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

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