MOMI Annual Report 2024

STEVE N. CARITIS

MOMI BIOBANK

ANNUAL REPORT FY2024: July 2023 – June 2024

The MOMI story

MOMI Leadership Sara Arvay, MBA Janet Catov, PhD, MS Arun Jeyabalan, MD, MS Maria Kautter, MBA Rob Powers, PhD Yoel Sadovsky, MD, Former Executive Director

The desire for hospital-based clinical data to improve patient care and to encourage and support research led to efforts at Magee in the late 1970s to establish an obstetrics database. When the National Institutes of Health established the Maternal-Fetal Medicine Units Network in 1986 to support obstetrics research, a prerequisite to funding was the availability of an obstetric database. That requirement led us to develop a functional but primitive database.

MOMI Team Owomide Adeyemi, MPH Natalie Bak Jae Boyd Tess Capo Courtney Dawson Destiney Davis Emily Immel, BSN Shaterra Jackson Kristen Kamp, MPH Londyn Pollock Maria Strish Jeannette Wellman, MBA Olivia Whitham

It was not until 1996 under the direction of Mary Jane Krohn, PhD that digital links to the hospital billing system enabled a more extensive database to be developed; we called that database MOMI (Magee Obstetrical Maternal and Infant database).

MWRI Erie Campus Ashley Berg, MS Kristin Honhart Linda Paterniti, RPh Erica Senyo

The MOMI database and its use for patient safety, clinical care and research has grown dramatically under the guidance of Janet Catov, PhD. The addition of the Biobank in 2017 under the leadership of Yoel Sadovsky, MD and colleagues and its linkage to MOMI transformed MOMI from a simple data repository to a research resource with few parallels. That resource has been expanded recently with the addition of clinical data and biological specimens from the Erie campus.

Research that utilizes the MOMI Database and Biobank is not limited to counts of patients with specific conditions but rather enables exploration of the mechanisms of disease by enabling analyses of tissues from patients with those specific diseases.

My hope is that the MOMI database and Biobank continue to improve and expand, providing a resource that assures that Magee and other researchers will continue to be at the forefront of pregnancy research.

Sincerely, Dr. Steve Caritis

MOMI Ethics and Advisory Committee Nesta Bortey-Sam, PhD Traci Day, MSW Brenda Deirgaarde, PhD Kristin Komazec, MPH Anne-Marie Rick, MD, PhD Courtney Weir, MS Toby Yanowitz, MD Contributors Alex Bauer, BA Erin Betler Tianjiao Chu, PhD Gina Edwards Elizabeth Krans, MD, MS Nicholas Masterson Samantha Mayo Joan McSorley Maya Patterson Janey Zoltun MWRI Leadership Mike Annichine, Chief Executive Officer Pamela Moalli, MD, PhD, Interim Executive Director Clinical Partners Magee Outpatient Clinical Laboratory Pregnancy and Womens Recovery Center University Obstetrics & Gynecology University of Pittsburgh Physicians

MOMI in review

The Steve N. Caritis Magee Obstetric Maternal and Infant (MOMI) Database and Biobank began in 2017 with the launch of an operation to pair biospecimens with the landmark MOMI Database, which dates to 1995. In the eight years of the Biobank’s enrollment, over 7,000 pregnant individuals have joined MOMI, providing clinical data and specimens throughout pregnancy and at delivery to power maternal and infant health discoveries.

The MOMI Database contains over 300 clinical variables from the electronic health record linked to participant biospecimens, creating a powerful resource for scientific inquiries into perinatal health. Specimens and data are made available to IRB- and MOMI Committee-approved projects by request.

MOMI resides on the hospital and academic campus, jointly situated in the UPMC MageeWomens Hospital and Magee-Womens Research Institute (MWRI). The specimens that participants provide during their clinical care at Magee undergo rapid processing and are entered into storage at MWRI with the use of a unique, web-based inventory system, generously maintained by UPMC and called the Biospecimen Inventory and Operational System (BIOS). MWRI faculty leadership and an Ethics and Advisory Committee oversee the dynamic operation made possible by support from the Richard King Mellon Foundation along with a contribution from the Hamot Health Foundation and an in-kind gift from Dr. Steve Caritis.

The initial years of MOMI established an effective, clinically driven enrollment model with MOMI embedded in the Magee clinical laboratory and delivery units aligned with clinical care. This operation, alongside high-quality processing and storage procedures, contributed to proof of concept. In recent years, MOMI has grown to deliberately reach people underrepresented in biomedical research; bolstered its request and disbursement processes; expanded and diversified its Ethics and Advisory Committee; and generated enrollment for numerous studies within and outside of MWRI. FY2024 launched MOMI into a new phase, with a record number of specimens requested and disbursed to scientific teams at MWRI, Pitt, and institutions across the country. Headed into FY2025, MOMI will continue its clinically propelled enrollment, high quality biospecimen processing, and rigorous data services while adding new programs to reach participants at greatest risk of developing pregnancy complications, upgrading the Investigator request platform, and launching a Clinical Ambassador initiative. These updates will bring even more intention to working with pregnant individuals who experience pregnancy complications like preeclampsia and preterm birth. Improvements to the administrative processes for data and specimen requests will accelerate scientific study and shorten the distance to discovery.

In year 8, MOMI is applying lessons learned to better serve participants and the scientists who will improve the course of pregnancy for those ahead of them.

4

Over 7,200 pregnant people:

Blood Urine Placental Membranes Cord Blood Placental Images

90 new participants monthly 20 deliveries weekly

1st Trimester

2nd Trimester

100,000+ banked specimens

Team of nurses, recruiters, specimen processors, and scientists work with women across pregnancy

Delivery

3rd Trimester

+ 300+ data variables

Data Manager LINKS specimens and data for each request

MOMI BIOBANK Scientific discovery powered by pregnant people

MOMI Biobank Participants

BLACK 15%

Magee VS. UPMC Deliveries

LATINA 2% ASIAN 4%

BLACK B LACK 18%

ASIAN 6% WHITE 73%

WHITE 79%

LATINA 3%

5 out of 10 participants are diagnosed with a pregnancy complication such as preeclampsia, preterm birth, hypertension, or gestational diabetes

9,017

Total specimens distributed

70+ Publications reference MOMI using 41 Studies MOMI specimens Institutions 13 U.S. using MOMI specimens

Scientists are using MOMI to study:

• Omics of placentas affected by preeclampsia • Bioinformatic approaches to rapidly assess placental images at birth • The prediction of early onset preeclampsia • Opioid exposure and the placenta • Prenatal smoking and birth outcomes

FY2024 Program Highlights PARTNER STUDIES AND CO-ENROLLMENT In addition to the more than 7,000 participants enrolled in the Biobank, MOMI has partnered with study teams focused on specific pregnancy, postpartum, and newborn research topics to enroll 3,000 participants into their studies. As an MWRI Core, MOMI is committed to supporting recruitment for prospective, pregnancy-related studies. MOMI’s recruitment operation can be scaled for investigatorinitiated protocols to recruit pregnant, delivering, and postpartum people, and when possible, coordinate study visits across multiple studies, streamlining participants’ research experience and minimizing their time burden.

Two of these partnering studies completed enrollment in 2024. The Deep Phenotyping of Pregnancy study (DP3), funded by the Richard King Mellon and McCune Foundations, collaborated with MOMI to enroll nearly 500 participants. DP3 utilized specimens that participants provide to MOMI and added environmental, microbiome, and FitBit monitoring components, creating a novel blueprint of healthy pregnancy while examining the development of complications. The Miracle of Life study, sponsored by San Francisco-based company Mirvie Inc., also worked with MOMI to enroll nearly 1,200 pregnant people whose participation will contribute to the development of a predictive blood test for preeclampsia.

DELIVERY SPECIMEN SPECIALISTS The Obstetric Specimen Procurement Unit (OSPU), situated within a small footprint in the Labor and Delivery Unit at UPMC Magee-Womens Hospital, is a clinically integrated operation for collection of delivery research specimens. The OSPU is also an essential point of the MOMI longitudinal collection. The MOMI team works with women across pregnancy to collect prenatal specimens.

At delivery, these participants are greeted by members of the OSPU who arrange the collection of blood, urine, placental membranes, and cord blood, then rapidly process and transfer the specimens for appropriate storage in freezer or room-temperature cabinets.

MOMI+ Over 100 participants and counting have enrolled into MOMI+, which envisions a world-class resource within MOMI for perinatal health and substance use. Initiated and overseen by Dr. Elizabeth Krans, with generous support from the Scaife Family Foundation, MOMI+ works in close collaboration with the Magee-Womens Pregnancy Recovery Center, an outpatient care program supporting women with opioid-use disorder.

MOMI+ is named for its inclusive approach and additional postpartum specimens and data collection. A dedicated recruiter works with pregnant individuals across pregnancy and into the postpartum period.

Elizabeth Krans, MD MOMI+ specimens and data are available for research projects by request.

MWRI SATELLITE IN ERIE, PENNSYLVANIA MOMI has been a flagship program at Magee-Womens Research Institute Erie Campus since its founding in 2021. A dedicated team works with pregnant people receiving care at Magee Hospital in Hamot and the nearby Westridge Community Office during pregnancy and at delivery. Over 600 Erie residents have enrolled into MOMI, making up nearly 10% of MOMI’s enrollment. Their participation ensures that scientific findings are inclusive of women in communities beyond Pittsburgh’s academic environment.

7

FY2024 Program Highlights

UPDATES AND QUALITY ASSURANCE OF DATA AND SPECIMENS The MOMI Database includes data from medical records coding, admitting services, outpatient encounters, ultrasound, and other ancillary systems for all mother-infant pairs delivered at UPMC Magee-Womens Hospital. Quality assurance is conducted through regular reporting and validation studies that assess the accuracy and completeness of data. The export interface allows rapid updates of all MOMI data contained in the hospital’s central data repository. Driven by investigator-initiated protocols, this year MOMI enhanced its ultrasound imaging data as well as Pennsylvania vital record data that capture maternal and infant outcomes through one year after delivery.

Rigorously developed standard operating procedures (SOPs) guide specimen collection, processing, and storage. Quality assurance measures are embedded in SOPs with precise specimen handling instructions and distinction of collection time frames. The MOMI specimen processing team receives thorough and ongoing training. Regularly conducted spot checks ensure specimen integrity and allow the Scientific Director to maintain dynamic feedback with processing units.

Spurred by a recent investigator request, MOMI developed an SOP for the extraction of genomic DNA from blood serum. Utilizing this newly developed SOP, the MOMI team successfully processed over 500 specimens which have been incorporated into our BIOS inventory system that dynamically organizes incoming and outgoing specimens. The SOP will serve any future requests for genomic data.

BIOS has evolved alongside MOMI. Among updates is a new function that annotates specimens across co-enrolled studies. This operating update was developed to align with a new MOMI policy where studies enroll their participants into MOMI and with participants’ authorization they may request to reserve their banked MOMI specimens. Specimens are reserved for a limited amount of time, allowing researchers to build upon their existing data with future proposals that include MOMI specimens.

8

Research Requests

MOMI receives requests from study teams at MWRI, Pitt, and institutions across the country interested in banked specimens, data, prospective collections, study referrals and other services like specimen storage and an Honest Broker for de-identification of data.

• Fifty percent of MOMI’s entire disbursement activity took place in FY24 • Most frequently requested conditions: Preeclampsia and Preterm birth • MOMI has disbursed over 9,000 specimens to over 40 protocols Data from 2021 – Current

Type of Request

Type of Requestor

Industry 3%

Recruitment 15%

External University 17%

MWRI 38%

University of Pittsburgh 42%

Prospective Collection 11% Data 33%

Specimens 41%

9

MOMI Disbursements Locations

10

INSTITUTIONS THAT HAVE RECEIVED MOMI SPECIMENS AND/OR DATA OR HAVE PLANNED DISBURSEMENTS: Massachusetts General Hospital Penn State University* University of Alabama* Tulane University Mirvie Inc. University of Washington Cedars Sinai Medical System* Children’s Hospital of Los Angeles Baylor University University of Cincinnati University of Pittsburgh George Washington University* *denotes projects that are in progress

11

Request Highlights

FNIH BIOMARKERS CONSORTIUM-BIOMARKERS FOR RISK STRATIFICATION AND DETECTION OF EARLY-ONSET PREECLAMPSIA Preeclampsia is a serious pregnancy-related hypertension condition, which can lead to maternal and infant morbidity, mortality, and lifelong adverse health effects. Biomarkers that can detect preeclampsia early will enable interventions that can delay onset of preeclampsia, especially its most damaging form, early-onset preeclampsia. This three-year project will evaluate the predictive value of two circulating biomarkers—placental growth factor (PIGF) and pregnancy-associated plasma protein-A (PAPP-A)—during the first trimester of pregnancy. The project will use patient data and banked samples from more than 25,000 pregnancies representative of the ethnic and racial diversity found within the North American population. Qualified biomarkers resulting from this study will help identify pregnant individuals at high risk of developing early-onset preeclampsia, increasing the benefit of future and current therapeutic intervention and decreasing the regulatory burden for inclusion in clinical trials. MOMI is included in this Foundation for the National Institutes of Health (FNIH)-supported consortium. Dr. Janet Catov and Dr. Arun Jeyabalan, MOMI Faculty Leadership, have joined the project as co-investigators.

SOFTWARE TO RAPIDLY ASSESS PLACENTAL IMAGES This study, led by investigators at Penn State University and funded by the NIH National Institute of Biomedical Imaging and Bioengineering, includes MOMI within a consortium of academic institutions from the U.S. and Uganda to assemble digital photographs, measurements, and clinical data on more than 25,000 births to develop and validate software to assess placentas in any delivery setting. The resulting software will glean visual characteristics from the disc, cord, and membranes and accurately identify specific features (e.g., shape) and diagnoses (e.g., chorioamnionitis). The immediate information could impact clinical care before hospital discharge, and ease-of-use will allow inclusion in pregnancy research. This software may have the ability to strengthen traditional pathology exams by standardizing and enhancing the data collected, providing better information to pathologists.

12

Plans for FY2025

FILLING GAPS IN THE EMR MOMI is implementing a brief questionnaire that will collect prospective data on social determinants of health factors that may place women at higher risk of developing pregnancy complications. Many of these are not well documented in the health record. In addition to collecting information about preexisting conditions, respondents will be surveyed about their experience of stress, discrimination, and food and housing insecurity. This will ensure that MOMI is intentional about including participants with diverse backgrounds and those at greatest risk of developing pregnancy complications.

ADMINISTRATIVE UPDATES TO SCALE MOMI is working with MWRIF’s Digital Manager to scale its request system to meet the demand that continues to trend upward. The online system will provide an interface where study teams will submit inquiries for MOMI specimens and data. The Requestor interface will be optimized for ease of use, clarity of services, communication of request status from inquiry to disbursement, and tools to support proposals and IRB applications. Request analytics will be tracked from the platform. These analytics will power MOMI’s operational decision-making, providing insights into trends in study topics and MOMI utilization.

CLINICAL CARE AMBASSADORS MOMI will soon launch a campaign to enlist and acknowledge clinical care providers as ambassadors. MOMI’s operation takes place alongside clinical care, adding tubes to preexisting clinical blood work and coordinating collection with the Labor & Delivery Unit, making clinicians key in MOMI’s success in enrollment and specimen collection. In our current model, clinicians connect eligible patients with our MOMI team who provide information.

With this initiative we seek to empower our clinical partners to educate their patients about MOMI and to recognize their efforts in doing so. They are part of the MOMI team. The toolkit will include a short training, talking points that offer an overview of MOMI, and wearable items announcing their ambassadorship. Buttons, lanyards, and badge holders will read “Ask Me About MOMI”. These clinical ambassadors will be equipped with simple information about MOMI’s scientific value, what it’s like to participate, and how to enroll, so that they may share this information during trusted interactions with their patients.

15

THE STEVE N. CARITIS MAGEE OBSTETRIC MATERNAL & INFANT (MOMI) DATABASE & BIOBANK