Obstetrics
HOPE (Heart Outcomes in Pregnancy Expectations) (Dr. Cecila Avila)
Where:
Recruiting outpatient pregnant women with heart conditions
Inclusion criteria:
1. 18 years or older
2. Any pregnant person at any point in gestation (with singleton or multiple gestation) prior to delivery.
3. English and/or Spanish speaking
4. Attends at least one cardio obstetrics clinic visit
5. Must have one or more of the conditions within the following 6 categories
a. Congenital or structural heart disease
b. Aortopathies
c. Arrhythmia
d. Cardiomyopathies and heart failure
e. Coronary disease
f. Other
Exclusion criteria:
1. Previously enrolled in HOPE (current study).
2. Unable to participate in follow-up
a. Incarcerated or current prisoner
b. Current diagnosis of dementia
c. Subjects without a way to contact for follow-up
3. Refused participation in the study
4. Unable to consent for self
5. Traumatic aortic disease
6. Perpartum cardiomyopathy diagnosed in the current pregnancy (new diagnosis)
Contact: alessa.ramosvargas@stonybrookmedicine.edu
IMPAACT 2041 (Dr. Sharon Nachman)
Where:
Recruiting pregnant patient with hepatitis C virus (HCV) to describe pharmacokinetics (PK) and safety of glecaprevir/pibrentasvir (GLE/PIB).
Inclusion criteria:
Age: 16-45 years of age (inclusive)
GA: 14-32 weeks gestation, SINGLETON (no known anomalies, no growth restriction)
HCV status: At screening, detectable HCV RNA test result based on testing of a specimen collected within 30 days prior to enrollment.
Other labs within 30 days prior to enrollment:
• Hepatitis B surface antigen negative
• AST/ALT (<10.0 x ULN)
• Hemoglobin (≥8.5 g/dL)
• Creatinine (≤1.8 x ULN)
• INR (<1.5 x ULN)
• Platelet count (≥100,000 cells/mm3)
• Total bilirubin (<1.6 x ULN)
• HIV status
Exclusion criteria:
- Previous treatment for hepatitis C with a DAA regimen
- History of spontaneous preterm delivery at less than 34 weeks
- Shortened cervix less than 20 mm if noted on ultrasound
- Clinical diagnosis of acute hepatitis not otherwise attributable to hepatitis C with AST or ALT ≥2.5 x ULN, evidence of decompensated cirrhosis including history of or present variceal hemorrhage, ascites, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatocellular carcinoma, hepatorenal syndrome, or hepatopulmonary syndrome
- Any medical condition that the site investigator that participation in the study would be unsafe
- Receipt of any prohibited medication within 14 days prior to entry:
• ARVs and pharmacoenhancers: (Atazanavir, Cobicistat, Darunavir, Efavirenz, Etravirine, Lopinavir, Ritonavir)
• HMG-CoA reductase inhibitors: (Atorvastatin, Lovastatin, Simvastatin)
• Other
• Carbamazepine
• Medications containing more than 20 mcg ethinyl estradiol (e.g., combined oral contraceptives)
• Proton pump inhibitors
• Rifampin, rifapentine, rifabutin
• Nirmatrelvir/ritonavir
• St. John’s wort (hypericum perforatum)
Contact: David.Garry@stonybrookmedicine.edu & sharon.nachman@stonybrookmedicine.edu
Effect of Metformin on Vitamin B12 Levels in Pregnancy (Dr. Jennifer Choi)
Where:
Recruiting pregnant patient who failed GTT.
Inclusion criteria:
- Women>18 years of age and pregnant
- Diabetic (either gestational or pregestational)
- Not already on metformin
Exclusion criteria:
- Known B12 deficiency
- Strict vegan diet
- Known pernicious anemia (intrinsic factor deficiency)
- Known malabsorptive diseases
- Chronic pancreatitis
- Imerslund-Graesbeck syndrome
- History of gastric bypass
Contact: samantha.gobioff@stonybrookmedicine.edu
RCT on Using Single (oxytocin) vs Double (oxytocin + misoprostol) Uterotonic Agents to Prevent Postpartum Hemorrhage (Dr. James Bernasko)
Where:
Recruiting patients prior to delivery on L&D.
Inclusion criteria:
All women 18 years and older admitted for delivery at Stony Brook University Hospital who agree to participate in the study.
Exclusion criteria:
- Women under 18 years old
- Women with known coagulation disorders
- Women with planned cesarean hysterectomy - Women with known placental accreta spectrum disorders
- Women with known allergy to prostaglandins
- Women with known fetal demise
Contact: obgyn.sbresearch@stonybrookmedicine.edu
Perceived Agency in Decision Making for Cesarean Section (Dr. Joseph Chappelle)
Where:
Recruiting post cesarean patients in the postpartum unit.
Inclusion criteria:
- Individuals who underwent a Cesarean section at Stony Brook University Hospital and complete the first survey while inpatient after their delivery
- Age>18 years
- Speaks and reads English or Spanish as primary language
Exclusion criteria:
- Delivery of nonviable infant, neonatal death
- Current incarceration
Contact: angelina.mozier@stonybrookmedicine.edu
Circulating mRNAs from placental exosomes in pregnant women with substance use exposure (Dr. David Garry)
Where:
Recruiting patients in the third trimester who are on medications for OUD and a healthy control group.
Inclusion criteria:
- Have a viable pregnancy, 28 weeks gestation or greater
- 18 years of age or older
- Diagnosed with opioid use disorder (OUD), which is defined as misuse of prescribed opioid medications, use of diverted opioid medications, or use of illicitly obtained opioids (i.e. heroin).
- Medication for Opioid Use Disorder (MOUD) with buprenorphine or buprenorphine/naloxone
- Be planning to be delivered at Stony Brook University Hospital.
Exclusion criteria:
- Multiple gestations
- Carrying a fetus with known aneuploidy or anomaly
- Non-English speaking
- Pregnancy complicated by any of the following: Class 3 obesity, any form of hypertension, pre-gestational diabetes, rheumatologic disorders, fetal growth restriction (below 10%-tile), experiences delivery below 37 weeks, or other drug/substance use
Contact: Rachel.lee@stonybrookmrdicine.edu
Gynecology
Medicaid Sterilization Perceptions (Dr. Joseph Chappelle)
Where:
Recruiting patients during the 6 week postpartum visit
Inclusion criteria:
Providers
- OB/GYN physicians in Long Island and New York City
Patients
- 18 years of age or older
- Stony Brook patients presenting for post-partum visit
Contact: Alexa.PezzulichCourtepatte@stonybrookmedicine.edu
Gynecologic Oncology
Ovarian Cancer Organoid Study (Dr. William Burke & Dr. Medhi Damaghi)
Where:
Recruiting patients during the 6 week postpartum visit
Inclusion criteria:
- Age > 18 years
Exclusion criteria:
- Age < 18 years
Unable to consent
Contact: mehdi.damaghi@stonybrookmedicine.edu elayna.kirsch@stonybrookmedicine.edu
Salpingectomy vs. Salpingo-oophorectomy to reduce ovarian cancer risk in BRCA1 carriers (Dr. William Burke)
Where:
Recruiting patients with BRCA1 that did not have ovarian cancer risk reduction surgery.
Contact: Catherine.Izzo@stonybrookmedicine.edu
Randomized phase 3 trial on use of immunochemotherapy (Olvi-Vec) for ovarian
cancer treatment (Dr. William Burke)
Where:
Recruiting patients with platinum-resistant/ refractory ovarian cancer.
Contact: Catherine.Izzo@stonybrookmedicine.edu
Collaborations
PCOS and gut microbiome (Dr. Olga Aroniadis (Medicine)
Where:
Recruiting OCP naive patients during their first to the PCOS Center
Contact: Joseph.Lacomb@stonybrookmedicine.edu
Cord Blood Survey (Dr. Thomas Diacovo (Pediatrics)
Where:
Recruiting second and third trimester patients in outpatient clinics
Contact: barsha.chakraborty@stonybrookmedicine.edu
Brain Imaging of Mothers (BIOM) (Dr. James Swain)
Where:
Recruiting pregnant or up to five year postpartum including those with OUD, mental health illness, or healthy controls.
Inclusion criteria:
- Currently pregnant or have given birth within the past 5 years
- Able to understand and comprehend English to provide informed written consent and understand all study requirements
- History of- or diagnosis of- opioid use disorder, history of- or diagnosis of- a mental health disorder (e.g., anxiety, depression, PTSD), or healthy control without diagnosis of a mental health disorder
Exclusion criteria:
- Minors (under 18 years old)
- Those unable to give their consent for participation (i.e., those with legal guardians)
- Individuals who require immediate clinical care for suicidal or homicidal risk and/or meet the criteria for a psychotic disorder
- Inability to undergo an fMRI brain scan (e.g., claustrophobia, piercings, metal in body)
Contact: elle.eggers@stonybrookmedicine.edu
ROOTS Study (Dr. Kristin Bernard (Psychology))
Where:
Black and Latina patients in the third trimester
Contact: lauren.morrison@stonybrook.edu