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Published by monica.zdanukiewicz, 2017-03-13 15:34:41

BB_HOSPITAL

BB_HOSPITAL

from ResearchMARCHMichigan Archive for

Research on Child Health

Hospital Briefing Book:

A project by

Child Health Advances
with Mothers



“Si quaeris peninsulam amoenam circumspice.”
“If you seek a pleasant peninsula, look about you.”

Dear Colleague:

We invite you to participate in an unprecedented attempt to learn about the health of pregnant women in
Michigan and their children. Our coalition of Michigan scientists and health care providers has come together to
create a statewide program to gather information about the problems that pregnant women face in our state –
whether in the arena of nutrition, stress, infection, poverty or exposure to environmental pollution – that can affect
their health and that of their children. Most importantly, our goal is to find solutions to these problems, especially
the high and disparate rates of infant and maternal mortality and severe morbidity in our state.

We refer to this project as MARCH – Michigan Archive for Research in Child Health - because we archive
information obtained in pregnancy, follow families over time, and look for connections between pregnancy
experiences and later child health and development.

Your hospital or clinic has been carefully chosen to be part of a group of ten hospitals and twenty prenatal
care settings that reflect the population of our state in this effort, which is supported by the Michigan Health
Endowment Fund and the National Institutes of Health. Our protocol is simple, and we are committed to ensuring
that nothing we do interferes with the provision of medical care to your patients. Women’s participation is
completely voluntary.

This briefing book explains what we hope to do in your clinic or hospital. It includes the information you
need to be fully informed about this effort, including copies of our consent forms, descriptions of our survey and
our biological collections, and our medical record abstraction form. Should you need additional information, please
feel free to contact any of our five principal investigators listed below.

We deeply appreciate your willingness to consider participating with us in this unique venture, which is a
much-needed step in the MARCH towards improved health of mothers and children in Michigan.

Nigel Paneth MD MPH Michael Elliott, PhD Glenn Copeland, Director
University Distinguished Professor Professor of Biostatistics & Research Division for Vital Records
Departments of Epidemiology
& Biostatistics and Pediatrics & Professor of Survey Methodology and Health Statistics
Human Development Dept. of Biostatistics Michigan Department of Health
Michigan State University University of Michigan
[email protected] [email protected] and Human Services
517.884-3961 (734) 647-5160 333 South Grand
PO Box 30691

Lansing, Michigan 48913
517 335-8677

Douglas Ruden, Ph.D. Charles J. Barone II, MD FAAP
Director of Epigenomics Chair, Department of Pediatrics &
Department of Obstetrics
and Gynecology Credentials Committee
Institute of Environmental Henry Ford Medical Group
Health Sciences (IEHS) Clinical Associate Professor of Pediatrics
C.S. Mott Center for Human Wayne State University School of Medicine
Health and Development
Wayne State University [email protected]
[email protected] 313 874-9591
Phone: 313-577-6688

1

enee Canady, PhD Chris Chambers, MD Toby Citrin, PhD Keith English, MD Douglas Gage, PhD Cheryl Gibson-Fountain, MD Kara Hamilton-McGraw Margot LaPointe, PhD

“If everyone is moving forward together then

Executive Committee: Charles Barone, MD Andrea Cassidy, PhD Glenn Copeland, MBA Dana Dolinoy, PhD Michael Elliott, PhD John Hannigan, PhD Christine Cole Johnson, PhD Dani

2
Advisory Council: William Axinn, PhD R
el Keating, PhD

Jean Kerve
ert Welch, MD
Henry Lim, MD David McGreaham, MD Jeff Mason Terrence Monks, PhD Susan Moran, MPH Douglas Paterson, MPH Jackie Prokop, RN, MHA Laurie Solotorow Sam Watson Rob

success takes care of itself.” - Henry Fordr,PhD,MSc,RD Richard Leach,MD Patricia McKane, DVM, MPH Dawn Misra, PhD Nigel Paneth, MD, MPH Douglas Ruden, PhD Robert J. Sokol, MD EdenWells, MD, MPH

Child Health Advances
from Research With Mothers

is a collaboration of:
Henry Ford Health System
Michigan Department of Health and Human Services
Michigan State University

University of Michigan
Wayne State University

3

Child Health Advances

CHARMfrom Research with Mothers

What is CHARM? RESEARCH AIMS & IMPACT

CHARM is a statewide partnership that aims to MARCH will help our state develop better policies in maternal and child
understand how the course of pregnancy affects a health, safeguarding our population against maternal and infant mortality
mother’s health and the health of her children. With and severe morbidity.
funding from both the National Institutes of Health
(NIH) and the Michigan Health Endowment Fund, MARCH will help us learn how factors, such as:
CHARM is building a large pregnancy cohort.
I nfections Nutrition
What is MARCH? Environmental Pollutants
Medications Behaviors
MARCH is a large pregnancy cohort specifically designed in mothers may influence child health outcomes.
to be representative of our diverse Michigan population.
Children will be followed after birth to discover how Maternal Health
pregnany factors affect child health and development. At
the same time, we will learn about the health needs and Evidence
concerns in our state.
of impact on
The ECHO* Program
MARCH pregnancy Health Policy
The NIH now supports 35 programs across the nation
to investigate the earliest causes of childhood disorders Research Aims
and disabilities. CHARM is part of this large national
effort. *Environmental Influences on Child Health Fetal/Children’s
Outcomes Health

Selected Geographic Areas 11 Hospitals throughout Michigan
will provide birth info &
Our carefully chosen placentas from each mom
sample of Michigan
hospitals and Michigan prenatal care clinics 251
prenatal clinics in the to recruit participants for MARCH
lower peninsula
represents our state, 35 CHARM is one of 35 national
and are now reaching pediatric coordinating centers
out to those
hospitals and clinics Statewide doctors and scientists 45
for their participation contribute to the CHARM
in this effort. partnership

Ready to join us?

Be a part of one of the largest and
potentially influential studies of child
health to date! WE NEED YOU!

Contact us at: [email protected] or
(517) 353-8623 x112

4

Our Guiding Principles

Our first goal is to CHARM strives to
support and not make the protocols
disrupt the normal it uses as simple,
course of clinical care. non-invasive and
useful as possible.
We understand that each
hospital and community is We follow all HIPAA and
unique and we work to IRB guidelines and
have a bioethicist on
adjust our protocols to
accomodate your staff.
environment.

5

Child Health Advancesfrom Research
with Mothers

MARCH: Michigan Archive of Research on Child Health

How Can Hospitals Participate?

Placenta Collection Medical Record Abstraction

Having bonded mother and To understand factors `
child for 40 weeks, the associated with
placenta is a valuable severe morbidity
source of information. and mortality,
However, it is normally our recruiter will
discarded. By preserving preform medical
record abstraction.
these organs, you join us to
gain the knowledge necessary to These vital pieces of
prevent maternal and infant deaths. information can save lives

The placenta writes a
pregnancy’s entire history

The Plan is Quite Simple

Identify mother Medical Abstraction Form A CHARM
who is part of interviewer
the CHARM DONBame will collect
cohort. information
from mom’s

medical
records

After delivery of the placenta:

Rinse Proceed with
the organ shipment
with water
“Double-bag” and seal again.
Place into a flexible Store flat for one week.
heat-sealable bag with

formalin, then seal

Ready to join us? Contact us at: [email protected] or (517) 353-8623 x112

CHARM is supported by the American Congress of Obstetricians and Gynecologists, Michigan Department of Health and Human Services,
Michigan Hospital Associations, Michigan State Medicial Society, and Michigan Chapter American Academy of Pediatrics

Placental Shipment Protocol

Directions

1. Collect the fresh placenta.
2. Gently dislodge fresh blood clots (rinse with water).
3. Place flat into a flexible heat-seal specimen bag, and add formalin until the placenta

floats.
4. Seal the placenta and formalin in the bag.
5. Then place the sealed bag into a second heat-sealable bag and seal.
6. Lay flat for 1 week prior to shipping.
7. For shipping take 2-10 placentas and layer them in a box. Placentas should not be

compressed but should not be freely moveable. Box orientation “This side up”
should note how the placentas lie flat in the box.
8. Label and ship to

Carolyn Salafia / Phillip Necaise
Placental Analytics, LLC
The Institute for Basic Research
1050 Forest Hill Rd, Staten Island, NY 10314

Supplies Needed:

Note: All supplies will be provoded by the research team

• Heat Sealable Bag
http://www.calpaclab.com/flexible-heat-seal-bags-4-5-mil-seal
pak-500-series/kp-500-24

• EXTRA LONG TABLETOP POLY BAG SEALER - IMPULSE WITH CUTTER
http://m.uline.com/h5/r/www.uline.com/BL_2258/Extra-Long-Tab
letop-Poly-Bag-Sealer-Impulse-with-Cutter?keywords=

Seal and trim larger bags and poly tubing in one step.
Gently press to seal, then slide cutter across tubing to create a perfect sized bag.

7

Medical Record Abstraction Form

GENERAL INFORMATION 9. Multiple gestation: YN

1. Mother’s height: _____ feet _____ inches 10. >4 previous births: YN

2. Mother’s weight ______________ pounds 11. Estimated Fetal Weight >4000gms: Y N

3. Total number of hospital admissions during this 12. History of previous post-partum hemorrhage:
pregnancy including admission that led to YN
deliver _______________________________
13. Large uterine fibroids: YN
4. Total number of days in the hospital: _______
14. Severe Obesity (BMI>40): YN
5. Specify reasons for admissions prior to labor :
____________________________________ 15. Hematocrit <30% YN
____________________________________
____________________________________ 16. Platelets <100,000: YN

Month / Day / Year [High Risk] Did the mother have:

6. Date of delivery admission: __ __/__ __/__ __ __ __ 17. Placenta previa or low lying placenta: Y N

7. Date of birth of child: __ __/__ __/__ __ __ __

ADMISSIONS RISK ASSESSMENT 18. Suspected placenta accreta, percreta, increta:
YN

[Medium Risk] Did the mother have: 19. Active bleeding (greater than show) on admit:
YN

8. Prior cesarean, or uterine surgery or multiple 20. Known coagulopathy: YN

laparotomies: YN

8

Medical Record Abstraction Form

INTRAPARTUM RISK ASSESSMENT SEVERE MATERNAL MORBIDITY CODES
1 = Acute myocardial infarction
[Medium Risk] Did the mother have: 2 = Acute renal failure
3 = Adult respiratory distress syndrome
21. Duration of second stage of labor ____ hours 4 = Amniotic fluid embolism
22. Magnesium sulfate administered? YN 5 = Aneurysm
23. Diagnosis of chorioamnionitis recorded? YN 6 = Cardiac arrest/ventricular fibrillation
24. Duration of oxytocin use 7 = Disseminated intravascular coagulation
_____hours 8 = Eclampsia
9 = Heart failure during procedure or surgery
[High Risk] Did the mother have: 12 = Puerperal cerebrovascular disorder
13 = Acute heart failure/pulmonary edema
25. New active bleeding: YN 14 = Severe anesthesia complications
15 = Sepsis
SEVERE MATERNAL MORBIDITY 16 = Shock
& EARLY WARNING 17 = Sickle cell disease with crisis
18 = Thrombotic embolism
26. Was the mother diagnosed with one or more of the 19 = Blood transfusion
following Severe Maternal Morbidities codes? Y N 21 = Conversion of cardiac rhythm
22 = Hysterectomy
* a. If YES, please circle all SMM codes found, and 24 = Temporary tracheostomy
then enter the total number of codes found 25 = Ventilation
here: _______

9

Participant Consent Form

Participant’s Name: ___________________________________________________________
Study Name: Michigan Archive for Research on Child Health
Investigator’s Name: Nigel Paneth, MD MPH
Investigator’s Phone Number: 517-844-3961

You are being asked if you would like to participate in a research study taking place across Michigan called
MARCH (Michigan Archive for Research in Child Health).This study involves researchers from Michigan
State University, the University of Michigan,Wayne State University, Henry Ford Health System, and the
Michigan Department of Health and Human Services. MARCH is part of a large national effort, called
ECHO (Environmental Influences on Child Health Outcomes), to understand the earliest causes of
childhood diseases, including causes that may operate before children are born.

Why is this study being done?

We know that some factors in the environment during pregnancy and early childhood, such as lead, can
affect a child’s health and development. But there is much we do not know. By getting information now,
while you are pregnant, we can find out whether factors such as diet, environmental chemicals, infections,
hormones and more might lead to illnesses in children such as asthma or obesity or problems in
development. The goal of MARCH is to identify these factors, so that we can prevent them from causing
illness in children. At the same time, we want to learn about the problems and concerns of pregnant
women in our state and prevent illness in women too.

What are the risks or costs to me?

There are no known risks to you or your baby from participating and participation in this study is free.

Will I benefit from this study?

You likely will not directly benefit from this study, however your participation may help scientists and
doctors all over the United States learn if there are ways to prevent problems in pregnancy and childhood
health.

Will I receive any compensation?

You will be compensated for your participation in the study. All compensation will come in the form of
either a gift card or a check made out in your name. If you participate in the study today you will get a $35
Meijer gift card. If you participate in other parts of the study, you will receive more compensation. If you
participate in all parts of this project you will receive $475 worth of compensation over the next 6 years.

10

Participant Consent Form

What about my confidentiality?

All information collected in the MARCH study is strictly confidential.Your confidentiality and that of your
child will be protected to the maximum extent allowable by law. If we need to share information from our
research with others outside the MARCH team, we will give your information a unique code, so that
outside researchers will not have information such as your name or your child’s name; your address, email
or phone numbers; or any other information that can identify you. For your safety, only the MARCH staff
who manage the computer system or perform data analysis will see your real name.There are also staff
members at MSU who oversee research (Human Research Protection Program) and individuals who fund
this research who may see your name if they need to ensure that the MARCH project is properly
conducting research.

What do you need me to do?

Now I will tell you about the ways you can help the MARCH project. Participating in all parts of this study
is completely voluntary. Regardless of what you say today, you will be free to change your mind later. After
we are finished today, you will take home a copy of this form with all of your decisions.

1. Will you agree to answer a series of surveys, some by phone and some in person? If you
complete our 40-minute survey today we will give you you a $35 Meijer gift card for your time.
After your child is born, the MARCH research team will call you to complete brief 20-minute
telephone surveys, when your child is 3 months old, 1 year old, 3 years old, and 5 years old. Each
time you complete a survey, you will receive a $20 check.
a. Yes
b. No

2. Will you agree to allow MARCH to have some of the urine and blood that your doctor will
routinely collect throughout your pregnancy? When you give your doctor a urine sample, a small
amount will be set aside for MARCH to store.When you go for your routine blood draws, a little
more blood would be drawn than normal (2-4 teaspoons) and stored by MARCH as well.
a. Yes
b. No

3. When your baby is born, we would like to collect and examine the placenta. Placentas are often
kept by the hospital until no longer needed and are then discarded.Will you allow the hospital to
give the placenta to us for analysis once they no longer need it?
a. Yes
b. No

11

Participant Consent Form

4. The Michigan BioTrust for Health has stored dried blood spots left over from newborn screening
since 1987 (routinely collected in all hospitals by a small newborn heelstick). Some of these spots
are put aside to be used in research projects, and when your child is born you will be asked by the
state of Michigan for your consent to have these blood spots used for anonymous research.That is
the kind of research in which the investigator does not know whose blood spot is being used.

We are asking for permission to gain access to both your (if you were born in Michigan since
October 1987) and your child’s identified leftover blood spots.We need the spots to be identified
so that we can connect information we get from the spots to the other information you provide
us. We will use the blood spots only for research on mother and child health such as we
described above.

Once the MARCH study is finished, any remaining spots will be returned to the Michigan BioTrust
for Health. As an extra protection, each specific blood spot research project we do must first be
reviewed and approved by the Michigan Department of Community Health to make sure it is
making good use of your blood spots.

a. Yes
b. No

5. After your baby is born, we would like to look at the information on your child’s birth certificate.
To be sure we have the right baby’s birth certificate, we will need your Social Security number.Will
you give us permission to see your baby’s birth certificate?
a. Yes SSN:____________________________
If the number we recorded is not correct, please contact MARCH at ________.
b. No

6. The MARCH research team would like to collect information from your medical record and your
baby’s medical record after your delivery. Do you give us permission to do this?
a. Yes
b. No

7. Will you agree to let us visit you and your child at home to assess for health and child
development when your child is age two, four and six years old? Each visit will take approximately
3 hours.You will receive a $100 check for each visit. At each visit, we will take body measurements
on you and your child, ask you to complete surveys, and have your child participate in
developmental assessments.
a. Yes
b. No

12

Participant Consent Form

8. After your child is born we would like to have a stool (or “poop”) sample from your baby’s diaper.
This can be done from the privacy of your own home.We will ask you to collect this sample when
your child is around 3 months old.We will send you detailed instructions and a kit that will let you
easily collect and send the sample back to MARCH.We will send you a $10 check made out in
your name.
a. Yes
b. No

9. We would like you to send us your child’s baby teeth as they are naturally shed, usually between
age 5 and 10 years. You can send MARCH up to five teeth. For each tooth, you will get a $10
check.When your child is about 4, MARCH will send you a kit to collect the teeth and send them
back to us with no cost to you. Do you agree to send MARCH baby teeth from your child as they
are lost?
a. Yes
b. No

We would like to share biological specimens and information that you give us with other scientists.Your
information could be very helpful to scientists who are trying to solve important problems.We will not
provide any identifying information to anyone outside of the MARCH program. Before sharing any
specimens or information with researcher outside of MARCH, we will de-identify it by giving it a code that
makes it extremely difficult for anyone outside our study to identify you.

There are two types of scientists that we would like to share your information with.

10. The first group of scientists are doing research in our national ECHO study to determine how the
environment affects childhood health, research that is very similar to what we do in MARCH. Do
you give us permission to share your and your baby’s de-identified information with these
scientists?
a. Yes
b. No

11. The second group of scientists may be studying topics other than child health, and we do not yet
know what these other topics might be. However, your MARCH information may be very helpful
to them in solving other medical and health problems. Do you give us permission to share your
and your baby’s de-identified information with these scientists?
a. Yes
b. No

13

Participant Consent Form

12. Finally, some scientists, both in and outside of the ECHO study, might want to study your genes or
the genes of your child.We know genes and DNA can affect health and illness so researchers are
very interested in how they might affect mothers and children.They might want to use the
specimens from you or your child to do these genetic studies. Do you give us permission to share
your and your baby’s de-identified genetic information with these other scientists?
a. Yes
b. No

13. Will you agree to allow us or other researchers to contact you to see if you are interested in
participating in other research projects that may develop over time? If another researcher is
interested in contacting you for additional studies MARCH will provide them with your contact
information so they can call you with more information about the particular study they would like
you to participate in.
a. Yes
b. No

What if I decide to not be a part of this study?

The MARCH project is completely voluntary.You have the right to refuse to be in the study or to stop at
any time.You can also choose to participate in only certain parts of the MARCH study with no penalty. If
you decide to stop the study, please contact the Principal Investigator, Dr. Nigel Paneth, in writing, by phone,
or by email.You can send a letter to Dr. Nigel Paneth, Michigan State University, Department of
Epidemiology, B636 West Fee Hall, East Lansing MI 48824.You can call him at (517)-844-3961 or contact
him by email at [email protected].

Will I have access to the information in my MARCH study record?

You can have access to any of your own MARCH study data anytime by contacting the Principal
Investigator, Dr. Nigel Paneth. If you have any questions about the study, such as how your information will
be used, how to do any part of the project, or to report a complaint, please contact Dr. Paneth at
(517)-844-3961.

Who can I contact about my rights/role within this study?

If you have questions or concerns about your roles and rights as a research participant, would like to obtain
information or offer input, or would like to register a complaint about the MARCH study, you may contact,
anonymously if you wish, the Michigan State University’s Human Research Protection Program at
(517)-355-2180, FAX (517)-432-4503, or email at [email protected], or regular mail at 207 Olds Hall, MSU, East
Lansing, MI 48824.

14

Further Points of Contact

Contact Principal Investigator
Nigel Paneth MD MPH

University Distinguished Professor
Departments of Epidemiology &
Biostatistics and Pediatrics & Human Development

Michigan State University
College of Human Medicine
909 Fee Road, Room 614B

East Lansing, MI 48824
(517) 884-3961 (Office)
(517) 290-5062 (Cell)

[email protected]

Principal Investigator in
Charge of Hospital Engagement
Charles J. Barone II, MD FAAP

Chair, Department of Pediatrics
Chair, Credentials Committee
Henry Ford Medical Group
Clinical Associate Professor of Pediatrics
Wayne State University School of Medicine

1 Ford Place 4B
Detroit, MI 48202-3450
(313) 874-9591 (Office)

[email protected]

Program Director
Tracy E. Thompson, MPH

Program Director
Child Health Advances from Research with Mothers

Department of Epidemiology and Biostatistics
Michigan State University

College of Human Medicine
909 Fee Road, Room 655B

East Lansing, MI 48824
(517) 884-3961 (Office)
(616) 295-4922 (Cell)
[email protected]

15

Supporters

CHARM is proud of the support it has received throughout
Michigan. Organizations have provided strong support for this

effort, including:

Michigan Chapter of the
American Academy of Pediatrics

Michigan Chapter of the
American Congress of Obstetricians and Gynecologists

Michigan Department
of Health & Human Services
Michigan Hospital Association
Michigan State Medical Society

This project has received funding from:

National Institutes of Health
Michigan Health Endowment Fund

University Research Corridor
Henry Ford Health System
Michigan State University

University of Michigan
Wayne State University

16

Michigan Chapter

MIAAP Office
106 W. Allegan
Suite 310
Lansing MI 48933
(517) 484-3013
Fax: (517) 575-6285

President
Teresa Holtrop, MD, FAAP
Wayne Children’s Health
Access Program (WCHAP)
3013 W. Grand Blvd, #650
Detroit, Michigan 48202
(313) 832- 8269
[email protected]

President-Elect
Sharon Swindell, MD, MPH, FAAP
Ypsilanti Pediatrics
200 Arnet, Suite 200
Ypsilanti, MI 48198
(734) 649-1325
[email protected]

Executive Director
Denise Sloan
106 W. Allegan
Suite 310
Lansing MI 48933
(517) 484-3013
Fax: (517) 575-6285
[email protected]

17

Michigan Section
Office of the Chair

Jody Jones, MD, FACOG
Canton Obstetrics and Gynecology
49650 Cherry Hill Road, Suite 220
Canton, MI 48187
Phone: 734-398-78888
Fax: 734-398-7885
Email: [email protected]

This letter expresses support for and encourages cooperation with the efforts of the
Child Health Advances from Research with Mothers (CHARM), a collaboration
between the Henry Ford Health System, the Michigan Department of Health and
Human Services, Michigan State University, University of Michigan, and Wayne
State University. CHARM, with funding from the National Institutes of Health and
the Michigan Health Endowment Fund, is creating a statewide, probability-based
cohort of pregnant women who they plan to follow (at least) until the child is age 5
years.

The scientific premise underlying their work is that careful and detailed
exploration of the biological and social environment of pregnancy starting early in
pregnancy and in real time is the best strategy for uncovering underlying causes of
many childhood diseases not fully understood, such as asthma and the
neurodevelopmental disorders. In addition, studying these issues in a statewide,
representative sample allows the findings to be applied to the entire state
population. There has been slow progress in preventing the drivers of infant
mortality and maternal mortality, intellectual disability, as well as other health
outcomes. These are largely shaped in pregnancy and infancy. Through this
prospective cohort study, we will help answer the question: How do events,
exposures, and experiences of pregnancy and infancy influence risk of child health
outcomes? Enrollment will take place in obstetrical clinics across the state. Those
clinics and practices feed into regional hospitals.

We would like to engage your hospital to be part of this statewide effort.
Engagement will entail an agreement to allow collection procedure of formalin and
shipping of placentas from study participants who give birth in your hospital. This
collection entails a simple

18

Because the work is designed this way, it can substantially inform the state
regarding the types of programs and policies which will impact the health of
mothers and children. The information can help guide the formulation of maternal
and child health policy on the pregnant mother herself – her needs, her risks, the
barriers she finds to getting clinical and state services, and what policies might best
serve all mothers in our state. It will also identify preventable risk factors for both
maternal and infant mortality.
This project enjoys broad public support and has the potential to positively impact
our state’s public health. We encourage you to join us by supporting these efforts
where possible and working with us in attaining a probability-based cohort of
pregnant women in Michigan.
Thank you!

Jody Jones, MD, FACOG

Michigan Section Chair

19

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from ResearchChild Health Advances
with Mothers




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