Clinical Trials and Research for Maternal-Fetal Medicine

The Maternal-Fetal Medicine team at Froedtert & the Medical College of Wisconsin offers many trials and prospective cohort studies focused on maternal health.

Open to Enrollment

Type of Research Protocol ID & Study Title
Observational Slow Heart Registry

PI: Erika Peterson, MD

A prospective observational cohort study of fetal immune-mediated high-degree heart block.

Keywords: Pregnancy, Heart Block
Registry NAFTNet 01-13: Complicated Monochorionic Twin Pregnancy Registry

PI: Erika Peterson, MD

Keywords: Pregnancy, Monochorionic Twins, Registry
Interventional Gestational Diabetes and Pharmacotherapy (GAP)- A Randomized Controlled Trial Investigating Timing of Pharmacotherapy Initiation for Patients with Gestational Diabetes

PI: Anna Palatnik, MD

The goal of this study is to compare two different thresholds for initiation of medical treatment for gestational diabetes mellitus (GDM). Pregnant women diagnosed with GDM will be randomized to either start pharmacotherapy when they have reached at least 20% or at least 40% of capillary blood glucose (CBG) values above the target goal. The investigators hypothesize that a lower threshold of 20% elevated CBG levels, compared to 40%, will lead to lower rates of obstetric and medical complications.

Keywords: pregnancy, gestational diabetes, standardization of care
Interventional A Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation With a Short Cervix (PROSPECT)

PI: Anna Palatnik, MD

A Randomized Trial of Pessary and Progesterone for Preterm Prevention in Twin Gestation with a Short Cervix (PROSPECT)

Keywords: Pregnancy, Twins, Short Cervix, Progesterone, Pessary
Interventional Reducing the Risk of Chronic Hypertension and Improving Vascular Function Following Preeclampsia (REPAIR)

PI: Anna Palatnik, MD

A multicenter randomized controlled trial of postpartum patients with hypertensive disorders of pregnancy randomized to intensive blood pressure control versus usual care during the first 6 weeks postpartum. The study will take place at two clinical sites: Medical College of Wisconsin (MCW) and Northwestern University (NU). All participants will undergo BP monitoring, cardiovascular function assessment, and collection of cardiovascular biomarkers at baseline, 6 weeks, and 12 months postpartum. The primary outcome is a new diagnosis of stage I hypertension at one year postpartum.

Keywords: Pregnancy, Preeclampsia, Cardiovascular Health
Interventional Intensive Postpartum Antihypertensive Treatment (IPAT)

PI: Anna Palatnik, MD

The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.

Keywords: Pregnancy, Pre-Eclampsia, Gestational Hypertension
Interventional Preeclamptic Pstpartum Antihypertemsive Treatment(P-PAT)

PI: Anna Palatnik, MD

A Randomized Controlled Trial for Postpartum Antihypertensive Treatment of Women with Preeclampsia

Keywords: Pregnancy, Pre-Eclampsia, Gestational Hypertension
Interventional Preventing Common Obstetric Complications Through an Immersive, Medically Tailored Meal Program (PLATE)

PI: Anna Palatnik, MD

To improve birth outcomes for pregnant people and their babies by increasing their access to fresh, healthy food and providing lifestyle and health coaching during pregnancy

Keywords: Pregnancy, Gestational diabetes, Preeclampsia, food
Interventional Building TrUst and UNiting Teams Through DouLa partnErship (BUNDLE)

PI: Anna Palatnik, MD

The purpose of the BUNDLE Research Project is to build trust through collaborative partnerships between clinicians and community-based doulas to better serve Black/African American birthing families.

Keywords:Doulas, neonates, Pregnancy Usual care
Observational CHAP Maternal & Child Follow-Up Studies

PI: Anna Palatnik, MD

A follow-up cohort study of mothers from the primary CHAP trial to see if treatment of chronic hypertension in pregnancy influences the long-term risk of cardiovascular disease.

Keywords:Cardiovascular health, hypertension, pregnancy
Interventional MINDBP: Mindfulness and wearable biosensors to prevent hypertensive disorders of pregnancy

PI: Anna Palatnik, MD

The goal of this study is to test if mindfulness and wearable biosensors (Garmin watch) can help reduce the risk of preeclampsia in patients who are at risk for preeclampsia and meet criteria to take aspirin.

Keywords: Preeclampsia, mindfulness, Garmin watch, Pregnancy
Interventional Comparative Effectiveness of Two Aspirin Doses for Prevention of Hypertensive Disorders of Pregnancy: ASPIRIN TRIAL

PI: Anna Palatnik, MD

The goal of this study is to determine if 162 mg of aspirin per day during pregnancy is better at preventing preeclampsia than 81 mg of aspirin per day.

Keywords:Pregnancy, Preeclampsia, Aspirin
Interventional DECIDE: A Comparative Effectiveness Trial of Oral Metformin Versus Injectable Insulin for the Treatment of Gestational Diabetes

PI: Anna Palatnik, MD

The goal of this study is to compare oral metformin versus injectable insulin for the treatment of gestational diabetes.

Keywords: Pregnancy, Gestational Diabetes
Interventional The PEARL Trial: A Randomized Trial of Amnioinfusion’s Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure

PI: Brock Polnaszek, MD, MPH

This project is being done to evaluate whether warm amnioinfusion can reduce breathing problems in babies exposed to moderate-to-thick meconium-stained amniotic fluid and improve their early development.

Keywords: Amnioinfusion, Meconium, Neonatal morbidity, Developmental Screening, Maternal Morbidity, Neonatal respiratory morbidity, Umbilical cord gas and biomarkers, Healthcare Utilization
Interventional Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers (AMNIO-BRAIN)

PI: Brock Polnaszek, MD, MPH

A Pilot Randomized Controlled Trial of High-Protein Supplementation During Labor to Improve Glucose Control in Insulin-Treated Diabetes Using Continuous Glucose Monitoring.

Keywords: Amnioinfusion, Neonatal morbidity, Maternal morbidity, Umbilical cord gas, Healthcare Utilization, Neonatal hypoxic brain injury, Chorioamnionitis, Neonatal brain biomarkers
Observational Preconception To Toddler Study (PTTS)

PI: Jennifer McIntosh, DO, MS

Tracks health outcomes from the pre-pregnancy period through gestation and up to two years post-delivery, supporting women and children’s health research.

Keywords: Pregnancy, Preconception, Post-delivery
Registry Novel Role for Placental Endothelial Mitochondrial Dysfunction in Preeclampsia

PI: Jennifer McIntosh, DO, MS

This study uses placental, plasma, and cord blood samples to study changes in placental blood vessels and evaluate potential treatments for preeclampsia.

Keywords: Placental, Preeclampsia
Observational Impact of Non-Nutritive Sweeteners on placental drug transporters.

PI: Stephanie Olivier-Van Stichelen, PhD

This study assess the consumption of non-nutritive sweeteners (Sucralose, Acesulfame-K , Sacharin…) during pregnancy and their impact on the expression of placental transporters for drugs and fetal waste.

Keywords: Placental, Pregnancy, Preconception, Post-delivery
Observational Placental Protein glycosylation in gestational diabetes.

PI: Stephanie Olivier-Van Stichelen, PhD

We are studying the relationship between the O-GlcNAcylation of protein and the production of placental hormones to understand better what triggers gestational diabetes and other gestational complications.

Keywords: Placental, Pregnancy, Placental, Gestational Diabetes