Research Studies

Contributor: Patti Parker
Date: October 22, 2018

TOPS: Comparing pessary along with standard of care to standard of care alone in prevention of pre-term birth. Singleton gestation with no history of pre-term birth and cervix ≤20mm and dilation <3cm. Patients will be randomized to pessary arm or no pessary arm. Patients can be on vaginal progesterone per ACOG guidelines. Allison or Anthony at 982-4894

PROSPECT: Comparing pessary to vaginal progesterone to standard of care (no intervention) in prevention of pre-term birth. Twin gestation with no history of pre-term birth and cervix <30mm dilation <3cm. Patients will be randomized to pessary arm, vaginal progesterone arm, or placebo arm. Study is double-blind and placebo-controlled; patients cannot receive open label vaginal progesterone while on study. Allison or Anthony at 982-4894

HCV: Observational study on vertical transmission of maternal HCV infection. Eligible patients are HCV antibody positive with or without viral load. Allison or Anthony at 982-4894

TXA: Double-blind placebo-controlled to determine if prophylactic IV administration of 1g TXA at cord clamp reduces pRBC transfusion. Patients will be randomized to 1g TXA or normal saline placebo and will not be unblinded in the event of post-partum hemorrhage; only one open label dose of TXA can be given. Singleton and twin gestations are eligible. Patients with seizure disorders (requiring medication), thrombophilias (including APLS), history of VTE, certain autoimmune diseases (Lupus, IBD, Sjogren’s, etc.), who require pre-op heparin, refuse blood products, or require a pre-delivery transfusion are excluded. Graves’, Hashimoto’s, and T1DM are NOT excluded. Unscheduled c/s are able to be consented and are only enrolled if they have a c/s. Enrolled patients less than 34 weeks must discard all breastmilk for 24 hours post-partum. Allison or Anthony at 982-4894

MOMPOD:  Comparing the safety and efficacy of insulin versus insulin plus metformin for treatment of type 2 diabetes mellitus complicating pregnancy. Key Inclusion Criteria – singletons; age 18-45; overt T2DM defined as either Preexisting T2DM requiring medical treatment (oral agent or insulin) OR overt diabetes diagnosed at < 22 weeks 6 days gestation. Gestational age at randomization between 10 weeks 0 days and 22 weeks 6 days by menstrual dating confirmed by ultrasound or ultrasound alone; English or Spanish speaking. Key Exclusion Criteria: no bariatric surgery. Alexis at 5-4872 or Cheryl at 5-5951

PIINC: “Psychosocial Intervention, Maternal Inflammation, and Birth Outcomes: Centering vs. Routine Prenatal Care –PIINC”. Enrolls women who are enrolled into the Cradle study. Involves a maternal blood draw at 12-22 weeks and again 32-36 weeks gestation as well as collection of placental samples at delivery. Angela at 5-2810 or Brittany at 5-8009

Treetop: The sponsor is working towards developing a lab test to provide an affordable and portable solution for prediction of spontaneous preterm birth. Patients who have had an ultrasound between 6 weeks and 13 weeks and 6 days with a singleton gestation are eligible for the study. There will be 1 to 2 study visits where research staff reviews medical history and a blood draw. Yana at 5-1568

VBAC: The purpose of this study is to establish a safety profile for mom and baby in the practice of water immersion labor and/or delivery after a previous c-section. Bethany Arrington is the PI. Enrollment is at 293/300. Yana at 5-1568

CRADLE: The purpose of this study is to measure the difference in preterm births by race between patients who attend CenteringPregnancy group prenatal care and traditional, individual prenatal care. Patients are randomized 1:1 into either Centering or individual care (stratified by race), and must attend at least 5 visits of whichever kind they are assigned. Alice at 5-3619 / 546-0089, Sarah at 5-5932, or Alexis at 5-4872