Agenda for Computers in Perinatal Medicine meeting 2002

Scientific Forum and Special Focus Group Reports
from the Society for Maternal-Fetal Medicine’s 25 th
Annual Meeting
Following are summaries of the Scientific Forums and Special Focus
Groups held at the SMFM 25th Annual Meeting. Scientific Forums and
Special Focus Groups meet in conjunction with the SMFM Annual Meeting
however the opinions and conclusions expressed in these summaries are
not necessarily the views of the Society.
COMPUTERS IN MATERNAL -
FETAL MEDICINE
Feb 9th 2005 3:00 – 6:00 PM
Reno, Nevada
The scientific forum was very well attended with 40 + participants including 7
participants presenting.
Computerized labor management can be a
reality with adequate labor monitoring. The
objectiove, computer based labor monitor was
presented and discussed by Dan Farine MD.
Mount Sinai Hospital, University of Toronto.
This new method of labor evaluation could
replace subjective digital evaluation with
computer based, continous labor monitoring
system.
Newly developed, computer generated,
fetal real time 4 dimensional
echocardiography was presented by Dev
Maulik, MD. Professor and Chairman of
Ob.Gyn Department Winthrop Hospital,
NY. Advantages of volume scan using
matrix transducer were outlined and
computer aided image generation was
presented.

Dr Shraga Rottem from Ironfan
Institute, Columbia Univ, NY Center
presented AI based early pregnancy
diagnostic algorhytm to detect fetal
abnormalities by sonography. AI for
First Trimester Genetic Mapping by
Ultrasound is designed to help
physician correctly diagnose fetal
abnormalities.
Computer assisted simulation of
emergency conditions in labor room was
presented by group of Dr Ariel Many, MD
Lis Hospital, Tel Aviv, Israel.
Specific obstetrical situations can be
dealt with more effectively if studied in
simulation enviroment.
Integration of Research and Clinical Information
Systems in OB/GYN was presented by Dr Sean
Blackwell from Wayne State Univ, MI. His
group has developed computer system
designed for the needs of the active Ob/Gyn
department. Image management, patient’s
documentation, medical research and other data
are integrated in one system.
Informatics and Beyond, was a topic of the
presentation of Dr Emily Hamilton, from
McGill Univ. QE, Canada. Dr Hamilton has
developed computer system that can
monitor and help in making correct
decisions in managing obstetrical
situationsmore efficiently.

Intelligent patient’s record; from data to
information. Experience with implementation of
electronic medical recordsb that monitors clinical
decisions was presented by Shoshana
Haberman, MD, Maimonides medical Center,
NY. Dr Haberman experience was significant in
being consistently in use for several years with
measurable improvements in obstetrical care.
Experience with Development of Prenatal
Electronic Medical Records was presented
by Bruce Chen, MD from Tripler Med Center,
HI. In his presentation Dr Chen has
reviewed difficulty and limitations in
developing electronic medical records even
if institutional support is available. His
experience is invaluable to anyone planning
on developing such a records
Andrzej Lysikiewicz, MD, PhD. Winthrop
Hospital, SUNY, Nypresented Computer
assisted 3 D fetal biometry, VOCAL (virtual
organ calculation analysis). This
technique allows for
volumemeasurementsof fetal organs
recreated in computer model.
Members interested in active participation in future meetings are invited to contact Dr
Andrzej Lysikiewicz or Dr Sean Blackwell with any suggestions or plans for the future
meetings.
Special Interest Group - Computers in Maternal Fetal Medicine
A. Lysikiewicz MD,
Director, Perinatal Ultrasound.
Winthrop Hospital, Mineola, NY
120 Mineola Blvd Suite 110, N.Y, N.Y.11501
Tel - 516 663 3020.
Alyss@msn.com

Critical Care Summary
Leader: Stephanie Martin, MD
Once again, several interesting cases were presented for a lively and interesting
discussion. Walter Harry, a maternal-fetal medicine fellow from the University of
Arizona, and Stephanie Martin, a perinatologist from Phoenix, AZ, highlighted the
importance of advance planning and preventive therapy to minimize the need for blood
products in patients at high risk for hemorrhage. Options presented included antepartum
IV Iron supplementation, erythropoietin, acute normovolemic hemodilution, autologous
blood donation, and use of the cell saver technology.
Leah Battista, a Maternal-fetal medicine fellow at the University of California, Irvine,
presented an unusual patient with a large pancreatic pseudocyst during pregnancy. While
many in the audience expressed temptation to surgically excise the cyst due to its size and
presentation, Dr. Battista presentation of the literature supported the conservative
approach adopted by the patient's medical team. This patient educated us all!
Connie Graves, a perinatologist at Vanderbilt University in Nashville, TN, and resident
Patricia Scott, MD impressed the audience with their astute and timely diagnosis of
herpetic hepatitis and encephalitis. This patient certainly benefited from Dr. Graves'
prior experience with a similar patient and those in the audience have a new appreciation
for the manifestations and diagnosis of herpetic hepatitis.
We are looking forward to more interesting cases next year!
Stephanie Martin

2005 Genetics Special Interest Group
Leader – George P. Henry, MD
This year focused on implementation of First Trimester Risk Estimation.
Since I was one of the speakers Jack Larson was moderator this year.
Sherman Elias was a late addition to speak about progress on a
combined MFM and Genetics fellowship which should satisfy both boards.
David Krantz spoke about the largest private data base using nuchal
translucency, free BHCG, and PAPP-A; Demonstrating that it can be and is
implemented in the USA, with certification.
Mary Dalton had been a featured speaker during preparations for the
Faster Trial and she spoke this year on SMFM plans for NT Certification. The
entire program is available on the SMFM web site. The first question was when
the society would get to vote on this program. The answer was that the
program is already set up.
Jon Hyett, from London, reviewed the practicalities, principles, and
experience of the Fetal Medicine Foundation program.
Mark Evans reviewed multiple data sets and reviewed how new
technologies move from experimental to available without insurance
reimbursement to routine with insurance reimbursement.
The contradictory premise by George Henry was that First Trimester
Risk Estimation is NOT cost effective for advanced maternal age patients, in
this country, compared to routine amniocentesis for AMA. The first blush would
lead one to think that screening AMA patients and doing CVS on the 10%
screen positive would save money over amniocentesis for all AMA patients. But
with 80% detection of Down syndrome one must include the $1 million each
lifetime cost for cases which would not have been missed by amniocentesis.
Because CVS has a 1% pregnancy loss rate vs. 1/1100 for amniocentesis
screening results in more pregnancy losses. Amnios reveal ALL aneuploidy
while risk estimation misses 20% of Trisomy, 20% of Trisomy 18, and more sex
chromosome aneuploidy. Risk estimation is appropriate for low risk populations
to identify patients who could benefit from diagnostic testing.
Applying risk estimation to AMA patients:
1. Does not save money
2. Does not save pregnancies
3. Does do harm by falsely reassuring perhaps half of aneuploid pregnancies
Even 80% detection of Trisomy 21 is not good enough when we have a
very safe 100% accurate diagnostic test by amniocentesis. Risk estimation if
not diagnostic and is not a substitute for diagnostic testing by amniocentesis.
This yearly report is adjusted to include the 2004 report which was
withheld by SMFM. It was submitted on time and after much argument it was
finally posted 2 months later when you had no likelihood of stumbling upon it.
You may decide for yourself why SMFM may not have wanted you to see it.

Genetics Special Interest Group
2004
At the genetics special interest group, Shama Jari reviewed Smith-Lemli-
Opitz Syndrome with prenatal onset of growth deficiency as a result of a
metabolic defect which impedes production of cholesterol. SLO will become a
part of the differential diagnosis in cases of IUGR especially with a low serum
estriol.
Louise Wilkins reviewed the history and data regarding the possible
increased risk of genetic imprinting errors as a result of IVF, ICSI, embryo
manipulation and culture. There is now a registry at her center for Beckwith-
Wiedemann syndrome cases associated with IVF pregnancies.
The bulk of the program revolved around genetic screening- both first
and second trimester as in the FASTER TRIAL (first and second trimester
evaluation of risk). In our session it was clear from the SMFM abstracts and
preliminary lectures being given by FASTER TRIAL authors that their results
would not replicate the experience of other groups- some of which have a larger
experience than the FASTER authors.
Jon Hyett reviewed first trimester screening by biochemistry (free beta
HCG plus PAPP-A) and ultrasound for nuchal translucency. It is clear that
meticulous training and continued oversight is integral to success of such a
program. He also reviewed the variations of using first trimester followed by
second trimester screening (sequential) or of integrated screening where
biochemistry and ultrasound data from both first and second trimester are
obtained and combined before making an assessment of risk. Only then is the
option of the definitive diagnostic test offered to the patient.
The latter is the FASTER TRIAL model. The published computer model
by Nick Wald (SURUSS study) projects 85% detection of Down syndrome for a
1.3% screen positive rate. While this sounds as good as you could possibly get
it requires withholding the first trimester biochemical and ultrasound findings
from the patient. That would not be acceptable or legal in this country.
Professor Wald has acknowledged at the American College Medical Genetics

meeting that he holds a patent on the computer modeling system for integrated
screening.
Jon Hyett reports about 80% Down syndrome detection by first trimester
screening for a 5% rate of diagnostic CVS or amniocentesis. The FASTER
TRIAL ascertained only about 60% by first trimester screening. In their trial they
excluded “cystic hygromas” as a different finding than increased nuchal
translucency. This removed twenty-six Down syndrome cases which were, in
fact, seen to be abnormal, i.e. detected, on first trimester ultrasound. Including
those cases would have brought them close to the British and other USA
experiences.
When first trimester screening is being used most cases of Down
syndrome are detected (whether you accept 60% or 80%). The problem with
then adding a second trimester screening (biochemical and ultrasound) is that 3
of 5 or 4 of 5 cases of Down Syndrome are already absent so the cost benefit of
second trimester screening is severely degraded and may not be relevant to do.
In the US, using second trimester screening alone, we have about 80%
detection of Down syndrome for a 5% amniocentesis rate.
Simona Cicero reviewed the data on presence/absence of nasal bone as
a marker for risk of Down Syndrome. Adding nasal bone to first trimester
screening brings Down Syndrome Detection to above 90% by first trimester
screening. She emphasized again how critical teaching and meticulous
technique is to success with nasal bone visualization. Nasal bone was not a
consideration at initiation of the the FASTER TRIAL. It was added to the first
trimester scans partway through with a limited attempt to tell (but not teach)
people how to do it. None of the 9 Down Syndrome cases examined for nasal
bone were thought to have absent nasal bone on ultrasound. The FASTER
authors conclude that nasal bone is not effective. This simply proves again that
if you do not know how to do a test it will not work well. It reportedly works well,
with proper training and quality control, in England, the US, and internationally.
There is already a large data base in the US using biochemistry and
ultrasound for nuchal translucency. It has been modeled on the U.K.
experience with thorough teaching and certification of proper nuchal
translucency measurement. That database which is larger than the FASTER

TRIAL performs well with 90% detection of Down syndrome for a 5% screen
positive rate.
The session concluded with a summation and geneticist’s perspective.
The FASTER TRIAL was a huge federal financial commitment to attempt to
duplicate the British experience in the U.S. It will no doubt be published as a
lead article in a prestigious journal. It may take a while to be seen as a disaster
where a number of academic centers, armed with $13.5 million of federal funds,
couldn’t do screening as well as our European colleagues accomplished with
nearly no visible support.
Because integrated screening requires withholding first trimester findings
from the patient it would be wrong for the SMFM to attempt to implement a U.S.
program modeled after the FASTER TRIAL.
One must back up and look at the big picture of chromosome
abnormalities. The above screening focuses on Trisomy 21 and most Trisomy
18, but this is not even half of the chromosome abnormalities which happen to
families. Chromosome abnormalities are devastating to families emotionally
and financially. Down syndrome is a prominent focus with the costs of 100%
mental retardation requiring lifelong assisted living plus a 40% incidence of
congenital heart disease. Other chromosome abnormalities also have serious
consequences even threatening the intact continuity of families. Down
Syndrome is not the only problem. The other thing to note is that all screening
discussions involve maximizing detection while minimizing invasive diagnostic
testing on the assumption that amniocentesis is dangerous and to be avoided.
But amniocentesis is DIAGNOSTIC.
The most important abstract from the FASTER TRIAL shows the risk of
pregnancy loss from amniocentesis is 0.15%- far less than the 0.5% risk long
quoted by pessimists in any discussion of avoiding amniocentesis. There is
now published data (Lancet Jan. 24, 2004) that amniocentesis is cost effective
at any age or risk level. That study preceded the FASTER abstract - so
amniocentesis is, in fact, far more cost effective at any age or risk level.
The diverse approaches to screening appear to be superb for
identification of increased risk in patients who were not already known to be at
risk but may not be as appropriate for “risk reduction” by biochemistry or
ultrasound in women already known to have an indication for amniocentesis.

The fallacy of cytogenetics by ultrasound was explored in prior years’
sessions. Screening is a great application for low risk populations to identify
cases needing the option of further testing. If couples wish to avoid “the needle”
by using screening as their decision maker they should understand that after
amniocentesis they have no risk of a diagnosable chromosome abnormality in
their newborn. If their screening test gives them a statistically decreased risk, it
is their prerogative (or their government health care plan) to decline diagnostic
testing. That leaves them with a persistent chance of an abnormal outcome-at
least half of what it was a priori- which cannot be predicted or prevented by
presently available screening tests.
The only way to know that a fetus has normal chromosomes is to
examine the chromosomes. Patients may select that instead of screening. In
order to decrease human suffering as well as on a financial basis amniocentesis
should be increasing and not discouraged in the process of screening.
Screening for previously unknown risk plus more liberal use of diagnostic
testing will become the norm.
George P. Henry, MD

2005 SMFM Meeting
Maternal-Fetal Surgery Scientific Forum
Once again, the Maternal-Fetal Surgery Scientific Forum presented to a standing-room-only audience at
the Annual Meeting of the SMFM. The Forum began with a summary by Mary D’Alton, M.D., New York,
NY, of a fetal therapy workshop conducted at the NICHD in 2004. One of the major outcomes of the
NICHD workshop was a consensus that an umbrella organization to foster collaboration in the conduct of
quality research and clinical services during the diagnosis and treatment of fetal anomalies is needed.
Workshop participants agreed that such a group should be inclusive and broad-based with funding
capabilities. Several models of collaborative organizations were discussed.
Catherine Shaer, M.D., Bethesda, Maryland, provided an update of the ongoing MOMS Trial
(Management of Myelomeningocele Study), the NICHD-sponsored randomized trial of prenatal versus
postnatal closure of myelomeningocele. As of January 2005, 64 patients have been randomized. The
12-month follow up examinations have begun. Participating clinical centers are Vanderbilt University
Medical Center, CHOP, and UCSF. Candidates can obtain useful information at
www.spinabifidamoms.com or by calling 1-866-ASK-MOMS.
Louise Wilkins-Haug, M.D., Boston, MA, presented outcome data of balloon dilation of severe aortic
stenosis in X fetuses in the second trimester of pregnancy. The minimally invasive procedure was
technically successful in 22/29 subjects with a median gestational age of 24 weeks. In liveborn infants
following technically successful aortic valve dilation in utero, 6/20 (30%) have biventricular circulation.
Further information can be obtained by calling 617-355-8967/7893.
Jan Deprest, M.D., Leuven, Belgium, presented information about the European pilot study of congenital
diaphragmatic hernia (CDH) treatment in utero. Offered only to patients with severe disease with a low
likelihood of survival, therapy involves balloon occlusion of the trachea via a minimally invasive approach
in the second trimester of pregnancy. Further refinements include removal of the balloon after optimal
lung growth is documented, making an EXIT procedure unnecessary. Preliminary results have been
promising and a randomized trial is anticipated. Michael Harrison, M.D., San Francisco, CA, widely
recognized as the father of fetal surgery, discussed his 25 years of experience in the treatment of this
serious congenital anomaly. He applauded the refinements in the procedure introduced by the European
research group, and pointed out that the last U.S. trial began almost six years ago. Based on the
consistently encouraging outcomes reported in the European study, a new trial in the United States may
soon be anticipated.
Joseph Bruner, M.D., Nashville, Tennessee, presented an update on the pilot study of amnioexchange for
gastroschisis at Vanderbilt. A multicenter randomized controlled trial is planned and expected to begin
this year.
Douglas Wilson, M.D., Philadelphia, PA, described the CHOP experience in the treatment of lower urinary
tract obstructions (LUTO). Evaluation and therapy using vesicoamniotic shunting and/or cystoscopy are
offered. In the last four years, 76 patients were evaluated and 36 were found to be suitable candidates
for therapy. Twenty fetuses received shunts, and four underwent cystoscopic evaluation and treatment.
Wilson emphasized that to date, no randomized trials of LUTO therapy in utero have been conducted.
Interested parties can be referred to 1-800-IN-UTERO at CHOP.
Ruben Quintero, M.D., Tampa, FL, announced the completion of his quasi-randomized trial comparing
laser photocoagulation of placental anastomoses to serial amnioreduction for Stages III and IV twin-twin
transfusion syndrome (TTTS). The trial was stopped after 56 patients enrolled, with only one patient

choosing serial amniocentesis. The results showed improved survival rates in the laser group compared
to a matched amniocentesis control group. Results of the trial are remarkably similar to those generated
by the Eurofetus Trial of TTTS, published last year, and support claims of the superiority of laser therapy
for the treatment of severe TTTS. Robert Ball, M.D., San Francisco, CA, updated the forum on the
ongoing NICHD-funded randomized trial of laser therapy versus amnioreduction for treatment of TTTS in
the United States. Recent changes in the study protocol include the addition of a third laser center in
Cincinnati, OH. Subjects can now return home after treatment, and rescue laser therapy is available for
those failing amnioreduction treatments. Candidates can be referred to 1-888-FETAL59 (Cincinnati
Children’s Hospital), 1-800-IN-UTERO (CHOP) or 1-800-RX-FETUS (UCSF) for further information.
Timothy Crombleholme, M.D., Cincinnati, OH, stressed the importance of completing the NICHD-funded
TTTS trial and listed a series of research issues that have not yet been addressed.
Ruben Quintero, M.D., Tampa, FL, then invited participation in two new clinical trials. The Florida Institute
for Fetal Diagnosis and Therapy at St. Joseph’s Women’s Hospital, Tampa, FL, is seeking 60 subjects to
participate in a randomized clinical trial to assess the outcome of monochorionic-diamniotic pregnancies
affected by selective intrauterine growth restriction (IUGR) of one twin, managed either expectantly or by
selective laser photocoagulation of placental communicating vessels. Candidates must have IUGR (EFW
< 10 th %ile for EGA) of one twin, with absent or reversed end diastolic velocities in the umbilical artery, at
< 26 weeks’ gestation. Candidates must not have coexistent oligohydramnios-polyhydramnios (maximum
vertical pocket of amniotic fluid > 8 cm in one sac and < 2 cm in the other). In addition, the Florida
Institute is seeking 36 patients with iatrogenic previable premature rupture of membranes secondary to
genetic amniocentesis to participate in a randomized trial comparing use of the amniopatch to expectant
management. Amniopatch is the intraamniotic injection of platelets and cryoprecipitate. For further
information, please call 1-888-FETAL-77 or proceed to www.fetalmd.com.
The Scientific Forum on Maternal-Fetal Surgery was moderated by Joseph Bruner, M.D., Nashville, TN.

Summary of Proceedings for the 2005 SMFM Annual Meeting: Perinatal
Epidemiology Scientific Forum
Topic: Methodological Controversies in Obstetric Clinical Research
Course Description (as described in the meeting program): The focus of this
scientific forum will be two common areas of controversy in clinical research: stopping
clinical trials and selecting meaningful & important primary outcomes. The Forum
attendees will first review the operations of Data Monitoring & Safety Committees
(DMSC), highlighting general topics of debate and conflict regarding committee conduct.
Second, specific examples will be presented in which a clinical trial was stopped based
on a controversial decision by a DMSC. Points and counterpoints regarding the decision
to cease each trial will be outlined. Third, the benefits, limitations and pitfalls of using
surrogate or composite primary outcomes in clinical research will be presented,
incorporating examples from the obstetrical literature.
Moderator: David Stamilio, MD, MSCE, University of Pennsylvania Medical Center,
Philadelphia, PA.
Speakers:
• Dwight J. Rouse, MD, MSPH, Center for Research in Women’s Health and
Division of Maternal Fetal Medicine, University of Alabama at Birmingham,
Birmingham, AL.
• Elizabeth Thom, PhD, George Washington University Biostatistics Center,
Washington, DC.
• Mark Klebanoff, MD, MPH, Director, Division of Epidemiology, Statistics, and
Prevention Research, National Institute of Child Health and Human
Development, Bethesda, MD.
Proceedings:
Dr. Stamilio provided a brief description of the course goals and introduced the speakers
and their respective topics. (5 minutes)
Dr. Rouse presented a lecture entitled “Data Monitoring and Safety Committees
(DMSC): Operations & Conflicts.” In this lecture, he described the purposes and
functions of a DMSC. He described how to identify which studies need a DMSC. He also
described who should comprise the DMSC and how the committee should be managed,
including a charter, stopping rules, and guidelines for adjudicating committee
disagreements. (30 minutes)
Dr. Thom presented a lecture entitled “DMSC Controversies: When should a trial be
stopped?” In this lecture, she described reasons for Data and Safety Monitoring
Committees to recommend stopping randomized clinical trials and highlighted the
importance of establishing reasons for stopping a trial before the planned number of
patients have been recruited. She described some of the issues involved in the decision,
including statistical guidelines. She illustrated her points using three detailed examples
drawn from the MFMU Network, including the Steroids Trial (RCT of single course vs
repeated weekly steroids in women at high risk of preterm delivery 24-31 weeks), the
Progesterone Trial (RCT of weekly injections of 17 α hydroxy-progesterone caproate vs

placebo in women with previous spontaneous preterm delivery), and Trichomonas
vaginalis Trial (RCT of metronidazole vs placebo in women with trichomonas vaginalis).
(45 minutes)
The speaker/moderator panel answered questions from the audience about the benefits
and disadvantages of stopping a trial. There was considerable discussion and debate
regarding the circumstances in which the MFMU Network Steroids Trial was
discontinued by the DMSC. (15 minutes)
Dr. Klebanoff presented a lecture entitled “Surrogate or Composite Primary Outcomes:
Benefits, Limitations & Controversies.” For both surrogate and composite outcomes he
defined the types of outcomes, explained why they are used, identified advantages and
disadvantages of using these types of outcomes, and provided guidelines for their use.
He provided examples from the literature, including common surrogate outcomes for
preterm birth or preeclampsia studies and common composite neonatal outcomes for
prematurity studies. He also provided non-obstetric examples in which surrogate
outcomes have failed or helped us. (30 minutes)
The speaker/moderator panel answered questions from the audience about selecting
clinically meaningful surrogate or composite outcomes for studies in reproductive
epidemiology. (15 minutes)
Dr. Stamilio made concluding remarks and invited attendees to provide feedback on this
session and topic suggestions for future forums. Comments can be directed to Dr.
Stamilio via email ( dstamilio@obgyn.upenn.edu ). (5 minutes)
Total time: 2 hours 25 minutes