
Division Director
Mark B. Landon, M.D.
Faculty
William Ackerman, M.D.
David Colombo, M.D.
Celeste Durnward, M.D.
Hugh Ehrenberg, MD
Jay D. Iams, M.D.
Wanjiku Kabiru, M.D.
Douglas A. Kniss, Ph.D.
Richard W. O’Shaughnessy, M.D.
Philip Samuels, M.D.
Cynthia Shellhaas, M.D.
Perinatal Fellows
Mona Prasad, D.O.
Christopher Lang, MD
Britton Rink, MD
Funminiyi Ajayi, MD
Laboratory of Perinatal Research
Douglas A. Kniss, Ph.D., Director
William Ackerman, M.D., Co-Director
Taryn Summerfield, M.D., Research Associate
Ruth Li, B.S., PhD Student
Prenatal Diagnosis Program
Genetic Counselors
Laura Montgomery, M.S.
Betsy Schmalz, M.S.
Ultrasonographers
Rachel Brown, R.D.M.S.
Tara Campo, R.D.M.S.
Jennifer Center, R.D.M.S.
Lorenda Donaugh, R.D.M.S.
Nocole Dorsey, R.D.M.S.
Pamela Foy, R.D.M.S.
Rita Gottesman, R.D.M.S.
Tammy Kibby, R.D.M.S.
Juie Overmeyer, R.D.M.S.
Heather Shafner, B.S., R.D.M.S.
Sally Singer, R.D.M.S.
Diabetes in Pregnancy Program
Barbara Martin, RN
Catherine Varga, RN
Preterm Birth Prevention Program
Hetty Walker, R.N.C.
Fetal Treatment Program
Karen Rossi, R.N.
Maternal Transport Service
Laura Woitovich, R.N., B.S.N.
Clinical Research Staff
Francee Johnson, R.N., S.N.
Coordinator, NICHD Research Network
Sandra Brenner, B.A.
Valerie Curry, R.N.
Stephanie Fyffe, R.N., B.S.N.
Cheryl Latimer, R.N., M.S.
Dawn Cline, R.N., B.S.N.
Sara Frantz, B.A.
Secretarial Staff
Division Secretary
Susan DuPont
Tracy Janosik
The Division of Maternal-Fetal Medicine continues to provide perinatology
services at The Ohio State University Hospitals, Mount Carmel Medical Center,
and St. Ann’s Hospital. The Division currently includes eight MD’s providing
clinical care and Douglas Kniss, PhD, who directs the Laboratory of Perinatal
Research. In addition, we were pleased to recruit William Ackerman, MD, to serve
as co-director of the Laboratory of Perinatal Research.
Teaching
Division faculty continue to make daily rounds at University Hospitals with
residents, fourth year elective students, and third year medical students during
their clerkships on the 6 West Antepartum Service. Board checkout twice daily on
Labor and Delivery remains an important part of the teaching program. Division
faculty provide attending coverage of Labor and Delivery for both normal and
high risk patients at University Hospitals. Four weekly teaching conferences
(Monday Fellow’s Conference, Friday Prenatal Diagnosis Conference, Thursday noon
Peds-Ob-Anesthesia Conference, as well as weekly Grand Rounds), in addition to
four specialty clinics at OSU (High Risk Ob, Diabetes, Prematurity, and APSA
Clinics) give our faculty and fellows regular opportunities for student and
resident teaching. At Mount Carmel Medical Center, we also instruct residents
and third year medical students from OSU in the course of supervising the
clinical obstetric service, the Antepartum Treatment Room, and High Risk Clinic
on Thursday, as well as a new Obstetric Clinic on Tuesday. Elective students and
residents from other medical schools and hospitals continue to rotate on
University Hospitals’ Antepartum Service. Division faculty are active
participants in the Department’s annual fall postgraduate course and in
Division-sponsored conferences. Division faculty continue to lecture both
locally in our perinatal region and throughout the United States.
Fellowship
The Division maintains an ABOG-accredited three-year fellowship. Dr. Philip
Samuels is Fellowship Director. Dr. Saj Joy graduated in June, 2006. The second
year fellow is Dr. Albert Franco, and Dr. Mona Prasad is the first year fellow.
Patient Care
Patient care is emphasized by our Division as we meet the needs of complicated
obstetric cases throughout central Ohio. Women with high risk pregnancies are
referred to Ohio State by their physicians because of the excellence of our
faculty and patient care programs. These referrals are essential to our clinical
teaching programs and also provide subjects for clinical research trials.
High Risk Pregnancy Care
Care for the patient with a complicated pregnancy is available at OSU through
several offices and specialty clinics staffed by our faculty and fellows. The
High Risk Clinic at OSU, held each Monday, accepts referrals of high risk
patients from area clinics and physicians. Our fellows, assisted by residents
and faculty, supervise the care of women referred to this Clinic. The Clinic is
integrated with the High Risk Pregnancy Project, a joint effort of the
Departments of Pediatrics and Obstetrics and Gynecology and funded since 1975 by
the Ohio Department of Health to provide comprehensive support services to the
high risk gravida. Project staff include nutritionists Dorothea Dahl, R.D., and
Maureen Platt, R.D., and perinatal social worker Beverly Shapiro, M.S.W. The
Project is directed by Dr. Leandro Cordero of the Division of Neonatology. The
Project also is supported through Project SAFE (Dr. Landon-PI), an initiative
funded by the Columbus Coalition Against Family Violence, which provides staff
support and education to our housestaff about domestic violence, including
screening all pregnant women.
Diabetes in Pregnancy Program
The Diabetes in Pregnancy Program includes the OSU Diabetes in Pregnancy Clinic
and our private facility at Outpatient Services at Kenny Road. This program
ranks as one of the five largest in the United States, caring for women with
diabetes during their pregnancies. A team consisting of Barb Martin, R.N.,
Catherine Varga, R.N., a dietitian and members of the High Risk Pregnancy
Project work with Dr. Landon and colleagues in providing ongoing care from the
antepartum through postpartum periods. Clinics are held weekly. A team
conference is held weekly to review patient progress and discuss individual
patient concerns.
Patients are educated on the effects of diabetes on pregnancy, management
through self-glucose monitoring, and diet requirements at their initial visit.
Social and financial issues are discussed. Many women are treated with insulin
pump therapy. Regular clinic visits and phone contacts are ongoing to review
glucose records and initiate or adjust insulin as needed. Maintaining a
cooperative relationship with each patient is essential to achieve the goal of a
successful pregnancy.
During the past academic year, approximately 200 women were enrolled in the
Diabetes in Pregnancy Program. This included nearly 100 women with preexisting
diabetes. Ten percent of these women had vasculopathy, including renal disease.
Many women were admitted with a primary or secondary diagnosis of diabetes to
our hospital service. In addition, numerous pre-pregnancy and co-management
consultations were obtained for patients throughout the central Ohio area.
The Ohio State Prenatal Diagnosis Clinic offers genetic amniocentesis, chorionic
villus sampling, targeted ultrasound, color flow Doppler ultrasound, and
diagnostic cordocentesis for women at risk for having children with genetic
disorders or birth defects. All Division faculty participate in this effort,
coordinated by our genetic counselors, Betsy Schmalz, M.S., and Laura
Montgomery, M.S. The Division maintains a state-of-the-art prenatal ultrasound
facility at Outpatient Services at Kenny Road. Pamela Foy, R.D.M.S., directs
obstetric ultrasound and is assisted by Heather Shafner, Rita Gottesman,
Jennifer Center, Tammy Kibbey, Rachel Brown, and Tara Campo. All appointments
for prenatal diagnostic services are scheduled through a single telephone number
at 614-293-2222.
The Fetal Therapy Program at The Ohio State University offers diagnostic testing
and interventions with the goal of improving neonatal outcomes for select
complications of pregnancy. Members of the Fetal Therapy team include Dr.
Richard O’Shaughnessy as director, Dr. Saj Joy as the third year maternal fetal
medicine fellow, Karen Rossi as Nursing Program Manager, Sandra Dietrich as
Transfusion Services’ Prenatal Reference Laboratory technologist, Stanley Sells
from The OSU Medical Center Laser Center and Dr. Leandro Cordero from
Neonatology.
Complications of pregnancy that are diagnosed and evaluated for treatment by
this team include: maternal red blood cell or platelet isoimmunization,
twin-twin transfusion syndrome, fetal bladder outlet obstruction, non-immune
hydrops fetalis, fetal pleural effusions, fetal ascites or other abnormalities
that may be amenable to in-utero treatment. Available procedures include:
amniocentesis, amnioinfusion, amnioreduction, cordocentesis, fetal cystocentesis,
thoracentesis or paracentesis, intrauterine transfusions, laser photocoagulation
of placental vessels, middle cerebral artery peak velocity measurements,
septostomy, fetal shunt placements and EXIT delivery for fetal neck masses.
These procedures are performed at The Ohio State University Medical Center in
the triage area of labor and delivery with support from several hospital
services and staff members.
The Isoimmunization Committee consists of all the above team members (except S.
Sells) and meets weekly to make recommendations for each patient’s care based on
OB history and serum samples. This allows the majority of women to continue
receiving their OB care from their local obstetrician. If advanced monitoring
and/or treatments are required, the patient’s referral to Ohio State is seamless
because she is already known to the committee. This regional management of
isoimmunization allows for prevention of severely ill fetuses through early
diagnosis, regular monitoring and rapid intervention. Approximately 75-100
patients per year have maternal serum titers sent to OSU’s Prenatal Reference
Laboratory because of its recognized expertise in this field. During this year,
8 patients required cordocenteses, with 7 of these patients requiring 30
intrauterine transfusions for severe fetal anemia due to red blood cell
alloimmunization.
Laser photocoagulation of placental vessels for treatment of twin-twin
transfusion has been available since 2002 at the OSU Medical Center in
collaboration with the OSU Laser Center, joining a handful of centers in the USA
offering this treatment. During this year, 14 patients were referred with
twin-twin transfusion. Two received laser therapy at OSU, eight were managed
with amnioreductions and four were managed expectantly.
One patient was evaluated this year for fetal obstructive uropathy and was not
eligible for a bladder shunt. One patient was treated with intrauterine
transfusion for non-immune hydrops due to parvo virus. One patient with a fetus
with congenital high airway obstructive syndrome was delivered using the EXIT
procedure. One patient had a cordocentesis for diagnostics only.
Research efforts in fetal therapy include participation in multi-site trials and
maintenance of a comprehensive database of clinical data obtained from fetal
therapy patients. Fetal therapy has participated in randomized trials for
treatment of patients with alloimmune thrombocytopenia since 1998, with Phase IV
currently open. Dr. James Bussel is the principal investigator of these trials
at The New York Presbyterian Hospital at Cornell University. Abstracts and
articles are regularly written from the database under the following OSU IRB
approved fetal therapy protocols: Outcomes of twin twin transfusion syndrome,
Long term follow up of children diagnosed with urologic or bladder disorders
before birth, Perinatal care registry of fetal anomalies, and Isoimmunization in
pregnancy.
Fetal Therapy at Ohio State University has accepted an invitation to join the
newly established North American Fetal Treatment Network (NAFTNET). The goal of
this network at this time is collaborative research. Dr. O’Shaughnessy is a
member of the Steering Committee. The Ohio State University protocol, Oxidative
stress in fetuses with alloimmune hemolytic disease of the fetus and newborn,
was accepted by the Network at the inaugural meeting in April, 2006.
A collaborative Perinatal Program between Maternal-Fetal Medicine at The Ohio
State University and Columbus Children’s Hospital is being established. The goal
of this joint effort is to provide comprehensive care for families diagnosed
with a fetal abnormality by specialists and specialized services from both
institutions. This family care will start at diagnosis during pregnancy and
continue after birth until the child enters their pediatric specialty. Fetal
therapy research is also a major goal of this program with research initiatives
currently being identified. Education for professionals and patients will be
provided by a website and invitational programs.
The Prematurity Program meets weekly in the OSU Clinic Facility. Dr. Jay Iams,
Director, Hetty Walker, RNC, the Nurse Coordinator and the MFM Fellows provide
consultative care for women who are at increased risk for preterm birth. First
year residents attend this clinic to learn antenatal risk assessment and care
for women with previous preterm birth. They also learn the technique of
endovaginal sonography in pregnancy. Senior medical students on the Antepartum
High Risk Obstetrics elective also attend the clinic. The Clinic encourages
visitors, including many nurses and physicians from Ohio and beyond. The clinic
has had visitors recently from the University of Oklahoma, the Medical
University of South Carolina, and from Brazil and Switzerland.
This program serves 150-250 women per year, almost all because of a history of
one or more prior preterm births. Most are referred by faculty and resident
physicians at Ohio State and by physicians and clinics in central and southeast
Ohio. Patients have come from surrounding states such as Michigan, Kentucky and
West Virginia. Self-referrals are accepted.
Reason for Referral Number
History of 1 spontaneous preterm birth 108
History of 2 spontaneous preterm births 42
History of 3 spontaneous preterm births 11
History of 4 spontaneous preterm births 8
Preterm labor in the current pregnancy or advanced cervical dilation or
effacement 28
Multiple gestation 10
Evaluation for possible incompetent cervix 14
Cervical surgery of uterine abnormalities 9
Total 230
An additional 11 women with a history of preterm birth were seen for
pre-pregnancy consultation.
OSU is one of the few places in the United States with a program devoted solely
to this very high-risk population. Pre-pregnancy counseling for these women is
available and encouraged. During the initial visit, the Nurse Coordinator
obtains a thorough history and comprehensive risk assessment. Amenable risks are
addressed and patients are then directed to the appropriate resources. The Nurse
Coordinator provides each patient with extensive education about preterm labor
symptoms, pregnancy wellness promotion, the medical management plan, testing,
activity levels, surgery and medication. This patient specific education is
reinforced at each visit. Ms. Walker monitors patient status via frequent phone
calls. She fields approximately 100 additional patient generated phone calls
each week.
A social worker is available to assist with needs in the home. A financial
counselor is also accessible to those unable to continue working through their
pregnancy. WIC referrals are made for those in need. A registered dietician
interviews, educates and advises each patient. Smokers are encouraged and
offered participation in the on-site smoking cessation program as well as
contact with The Ohio Tobacco Quit Line. While in the waiting room, patients are
able to view tapes on preterm labor, multiples, breastfeeding, childbirth,
operative delivery, anesthesia and newborn care.
The program provides an opportunity for women to enroll in prematurity-related
research projects conducted by Dr. Iams and Division faculty and fellows.
Protocols sponsored by the NICHD MFMU Network that are facilitated by the
program include studies of progesterone supplementation for women with twins and
triplets (STTARS) and a trial of omega-3 fatty acid supplements for women with a
prior preterm birth (Omega). OSU also participates in the NICHD-sponsored
Vaginal Ultrasound Cerclage Trial, where our enrollment of randomized subjects
is third among 12 participating centers. Women with a prior preterm birth
between 16 and 34 weeks are followed with serial cervical sonography beginning
at 16 weeks; those whose cervical length is 25 mm or less before 22 weeks 6 days
are offered randomization to bedrest or cerclage. In three years, OSU has
screened more than 750 women to identify 82 eligible women, 56 of whom have
agreed to enroll. Interestingly, of the 26 women enrolled who subsequently had a
cervical length measurement of £ 25 mm, all have consented to randomization. The
NICHD Data Safety Monitoring Committee for VUCT reviewed outcomes in January
2006 for more than 150 women randomized nationally; there was no significant
advantage for patients in either arm, so the trial will continue to enroll until
at least 225 women are randomized. The local budget for VUCT approaches $100,000
annually.
Ms. Walker maintains a comprehensive, IRB approved database of outcomes for all
women seen in the clinic. This dataset provides information for abstracts and
articles by division fellows and faculty. Dr. Celeste Durnwald reviewed outcomes
according to obstetrical history and cervical length in a poster presented at
SMFM that generated a manuscript published in the American Journal of Obstetrics
& Gynecology in 2005. Additional research initiatives are ongoing.
The Prematurity Program also provides outreach education for clinics, hospitals,
physicians and nurses throughout Ohio. The March of Dimes has supported this
teaching effort for the last two years with grants totaling $19,000 for Dr. Iams
and Ms. Walker to visit many hospitals in Ohio. Talks on “The Care of Women at
Risk for Delivering Prematurely” have been delivered in Cleveland, Akron,
Athens, Mansfield, Gallipolis, Cincinnati, Dayton, Northern Kentucky,
Youngstown, Portsmouth, Cambridge, Findlay and Lima. Several physicians and
nurses have visited and observed the program to learn how to establish something
similar. Ongoing support is provided via phone and e-mail.
Maternal Transport Service
Summary of 519 Maternal Transports
(Hospital to Hospital)
July 2005 - June 2006
Admission Diagnosis
Appendicitis/Ruptured 2
Abruption 1
ABD Pain 14
Bleeding 28
Census Management 1
Cerclage 1
Cholelithiasis 5
Chorioamnionitis 2
Diabetes Control/DKA 5
Drug Detox 5
DVT 2
Evaluation of fetal well being 10
Fetal Anomalies 3
GI bleed 2
Hyperemesis 10
IUGR 1
Kidney Stone 2
Maternal Cardiac/Respiratory 12
MVA/trauma 5
Oligohydramnios 7
Pancreatitis 1
Placenta Previa 5
Polyhydramnios 1
Post Partum 8
Preeclampsia/HELLP/Eclampsia 69
PROM 131
PTL/ACE/ACD 161
Pyelonephritis 3
Seizures 3
Term Induction 3
Twin-Twin transfusion 2
VBAC 1
Other 13
Outcome Data for Transport and Referral Patients
July 2005-June 2006
Total patients 837
Transport 519
Referred 318
Total Deliveries 479
Neonatal Outcomes
NICU 409
Newborn Nursery 79
Expired/Stillborn 45
Transport to Children’s 118
Reversed to home hospital 32
Total Children’s Transports 196
Total Neonatal Reverse Transports 39
Maternal Transport Originating Hospitals
July 2005-June 2006
Level 1
Adena Regional Medical Center 46
Marietta Memorial 29
Southern Ohio Medical Center 38
O’Bleness Hospital 21
Memorial Hosp of Union County 32
Fairfield Medical Center 33
Holzer Medical Center 21
Mary Rutan Hospital 21
Coshocton Community Hospital 12
Berger Hospital 10
Fayette County Memorial Hosp 29
Hocking Valley Community Hosp 10
Others less then 10 each
Level 2
Genesis Bethesda Hlth Care System 47
Marion General Hospital 27
Licking Memorial Hospital 17
St. Rita’s Medical Center 14
Others less then 10 each
The Ohio State University Medical Center serves as one of the tertiary perinatal
centers for central and southeast Ohio, in cooperation with the Neonatology
Service at Columbus Children’s Hospital. During 2005-2006, there were 829
antepartum patients and 8 post partum patients admitted in transfer from area
physicians and hospitals for medical and obstetrical complications. Our Case
Management Nurse, Laura Woitovich, R.N., B.S.N., coordinates communication and
follow-up with hospitals and physicians who refer patients. An average of 210
calls are made monthly to referring physicians, hospitals, and clinics. She also
visits each hospital in Perinatal Region IV. The Division offers a toll-free
telephone line, 1-800-282-6502, to facilitate referrals to reach the
perinatologist on call for consultations or to transfer a patient, and is
answered 24 hours a day.
Research
Laboratory of Perinatal Research
Douglas A. Kniss, PhD, Professor and Director
William E. Ackerman IV, MD, Assistant Professor and Co-Director
Taryn Summerfield, MS, Research Assistant
Description of Research Activities in the Laboratory of Perinatal Research
Mechanisms of Parturition: Inflammation of Human Labor
The Laboratory of Perinatal Research (LPR) continues to focus much of its
efforts on studies of the molecular mechanisms governing parturition in both the
term and preterm settings. Work carried out by Drs. Kniss and Ackerman during
this past year have been principally concerned with understanding the expression
of genes involved in the production of prostaglandins, lipid mediators that
serve as the final common pathway for uterine contractility and cervical
ripening leading to birth.
Work performed by Dr. Ackerman has demonstrated that enzymes involved in
inducible prostaglandin synthesis, cyclooxygenase-2 (COX-2) and microsomal
prostaglandin E synthase-1 (mPGES-1), are coordinately regulated by the
transcription factor, NF-kappaB. Importantly, NF-kappaB is activated by
proinflammatory cytokines that are known to be present within intrauterine
tissues and amniotic fluid in association with infection, a leading cause of
premature birth.
During this past year, Dr. Ackerman was awarded a K08 physician-scientist grant
from the NIH to continue his studies on perinatal biology. This five-year award
will allow Dr. Ackerman to launch his career as an independent scientist in the
department. In addition to the studies mentioned above, Dr. Ackerman has
recently forged collaborations with intramural NIH investigators who study lipid
metabolism and trafficking, both critical components of inflammation.
In addition, a mutual interest in inflammation and labor has led to the
establishment of promising collaboration between the Laboratory of Perinatal
Research and the Perinatology Research Branch of the NICHD (Detroit, MI). In the
context of this relationship, investigators at both institutions will commit
resources to examine mechanisms governing the regulation of NF-kappaB in labor.
It is hoped that this joint venture will expedite the progress of research in
this area, which may one day be realized in the development of new stratagies to
decrease the incidence of preterm birth.
Stem Cell Biology & Regenerative Medicine
During this past year the LPR has focused increasingly on the use of embryonic
stem (ES) cells to model key developmental processes in early development. Mouse
ES cells have been shown to differentiate into a variety of cell types when
cultured in medium enriched in tissue-specific growth factors. A new development
this year was the introduction into the LPR of federally-approved human
embryonic stem cells which will serve as models for tissue differentiation. The
lab will also become the University’s principal core for embryonic stem cells
and we will thus broaden our scope of stem cell research to many collaborators
across the campus.
Nanoscale Topography & Cancer Stem Cell Biology
It has long been recognized that the 3-dimensional geometry of tissues
influences their development in vitro and in vivo. The LPR in collaboration with
Dr. John Lannutti of the College of Engineering have been using nanotechnology
strategies to model the effect of topography and geometry in tissue development
for almost 6 years. Recently, a collaboration between Drs. Lannutti and Matthew
Ringel of the Department of Internal Medicine and Comprehensive Cancer Center,
and Ruth Li, a PhD student in the LPR has embarked on a series of studies to
examine the influence of disruption signal transduction molecules (Akt-1 and MAP
kinases ERK-1/2) on the migration and proliferation of cancer cells (breast and
thyroid) and embryonic stem cells. These investigations will establish a new
working paradigm of cellular signaling that controls cancer cell migration as a
model for tumor metastasis and epithelial-to-mesenchymal transitions during
early development and tissue morphogenesis. This work is sponsored by the
Nanoscale Science & Engineering Center (NSEC) awarded to Ohio State in 2004 by
the National Science Foundation (Drs. Kniss and Lannutti are co-investigators in
the center).
Clinical Research Program
NICHD Maternal-Fetal Medicine Units Network
In 2005-2006 the Division completed its fourteenth year of participation in the
14-center MFMU Network. Other centers in this cycle of the Network include the
University of Pittsburgh, University of Alabama-Birmingham, Wayne State
University, Wake Forest University, University of Texas-Southwestern, University
of Utah, Drexel University, Brown University, Columbia, Case Western Reserve
University, University of Texas-Houston, University of North Carolina, and
Northwestern University. Dr. Jay Iams continues to lead the program as Principal
Investigator, and Dr. Mark Landon is the alternate PI. Francee Johnson, RN, BSN,
is the OSU Network Coordinator. The Network research team includes Cheryl
Latimer, RN, MS, CCRC, Stephanie Fyffe, RN, BSN, CCRC, Dawn Cline, RN, BSN, CCRC,
Sandy Brenner, BA, and Sara Frantz, BA.
During the summer we submitted our recompetition application for the next cycle
of the Network, and in January learned that we would be funded for the next five
years (2006-2011). Two of the current centers were not refunded, but 12 of the
current centers and two new centers will compose this cycle of the MFMU Network.
The new centers are University of Texas-Galveston and University of Oregon. Jay
Iams will continue as OSU principal investigator and Mark Landon will be the
alternate PI.
Dr. Iams is Chair of the MFMU Network Concurrent Research Committee and also
serves on the Protocol Prioritization Committee. He recently became a
subcommittee member for a new study that will be starting later this year, “RCT
of Progesterone to Prevent Preterm Birth in Nulliparous Women with a Shortened
Cervix”. During the past year, Dr. Iams has been a co-author on ten Network
publications. As local PI, Dr. Iams has overall responsibility for all Network
studies conducted at OSU.
Dr. Landon is OSU’s alternate Principal Investigator for the Network and chairs
the Network protocol subcommittees for the Cesarean Section Registry and the
Mild Gestational Diabetes Randomized Treatment Trial. Dr. Landon has presented
three Network abstracts at SMFM meetings including an oral presentation about
factors related to successful trial of labor after cesarean birth. In addition
to Dr. Landon’s first authored papers, the CS Registry has produced 20
additional abstracts and numerous other manuscripts published or submitted for
publication which Dr. Landon, as Chair of the CS Registry Subcommittee, will
oversee.
Ms. Johnson is the senior research nurse in the Department and manages three
research nurses and two research assistants working on Network protocols. During
the past year three of the research nurses passed the certification exam to
become certified research coordinators. Ms. Johnson serves on three Network
protocol subcommittees and is the nurse coordinator for all Network studies at
OSU. She also serves as a resource to residents and fellows in completing their
research projects.
Current MFMU Network studies being conducted at OSU are:
1. The BEAM Study, a “Randomized Clinical Trial of the Beneficial Effects of
Antenatal Magnesium Sulfate”, an investigation into whether supplemental
magnesium in the peripartum period can reduce or prevent intraventricular
hemorrhage and cerebral palsy in prematurely born infants. Study recruitment was
completed in 2004 and the two-year follow-up completed 12/06. (Dr. Iams, Local
PI)
2. “A Randomized Clinical Trial of Treatment for Mild Gestational Diabetes
Mellitus”, a potentially landmark study to determine whether treatment of mild
to moderately elevated glucose levels improves perinatal outcome in mild GDM.
(Dr. Landon, National and Local PI)
3. The CAPPS Study, a “Randomized Trial of Antioxidants to Prevent Preeclampsia”,
a placebo-controlled study of supplemental vitamins C and E to prevent pre-eclampsia
in nulliparous women. (Dr. Samuels, Local PI)
4. “An Observational Cohort Study to Predict Preeclampsia”, a longitudinal study
to identify predictive markers for pre-eclampsia. (Dr. Samuels, Local PI). A
companion study to the CAPPS protocol.
5. The STTARS Study, “A Randomized Clinical Trial of 17 Alpha-Hydroxyprogesterone
Caproate for the Prevention of Preterm Birth in Multifetal Gestation”. This
study is modeled after a similar study in women with a prior preterm birth,
where treatment with 17 alpha OH-P reduced the risk of recurrent preterm birth
by 35%. The twins stratum was completed 2/06 and the triplet stratum will be
completed 9/06. (Dr. Iams, Local PI)
6.“A Randomized Clinical Trial of Omega-3 Fatty Acid Supplementation to Prevent
Preterm Birth in Pregnancies at High Risk. (Omega-3) The purpose of this study
is to see if Omega-3 nutritional supplement in addition to 17P injections can
further reduce the rate of preterm birth in women at high risk. (Dr. Iams, local
PI)
NICHD MFMU Network Grant Funding
Each center of the MFMU Network is funded by the National Institute of Child
Health and Human Development through a combination of base budget and capitated
funding. The base budget supports 10% of the Principal Investigator’s salary,
100% of the Nurse Coordinator’s salary, 100% of one Research Nurse’s salary, and
50% of the Data Manager’s salary. All additional funds are earned through
capitation, a system in which the center receives a specific amount of funds for
each enrolled research subject; the amount varies with the complexity of the
study. Base budget funding at OSU for the next five-year cycle of the Network
will be $1,428,689 in total costs. Capitation funds will be awarded according to
recruitment in Network protocols.