Clinical Trials and Research for General OBGYN

Open to Enrollment

Type of ResearchProtocol ID & Study Title
ObservationalSlow Heart Registry

PI: Erika Peterson, MD

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

Keywords: Pregnancy, Heart Block
Interventional, Registry Fetal Atrial Flutter & Supraventricular Tachycardia (FAST) Therapy Trial

PI: Erika Peterson, MD

This multicenter randomized clinical trial aims to evaluate which standard medication (or combination of medications) for treatment of fetal supraventricular tachyarrhythmias is safest and most effective. Women who are not eligible for the randomized trial or who do not wish to participate may still be eligible to enroll in the observational registry.

Keywords: Pregnancy, Arrhythmia
RegistryNAFTNet 01-13: Complicated Monochorionic Twin Pregnancy Registry

PI: Erika Peterson, MD

Keywords: Pregnancy, Monochorionic Twins, Registry
Interventional, ObservationalNIH RECOVER: A Multi-site Observational Study of Post-Acute Sequelae of SARS-CoV-2 Infection in Adults

PI: Anna Palatnik, MD

A multicenter combined retrospective and prospective study of individuals who were pregnant since February 2020 with or without COVID-19.

Keywords: COVID-19, PASC (post acute sequelae of COVID-19), Pregnancy
Behavioral Social Risks-Focused Lifestyle Intervention to Reduce Preeclampsia (SAIL)

PI: Anna Palatnik, MD

Randomized control trial to determine group prenatal care (focused on preeclampsia prevention through stress management, stress reduction techniques, resource navigation, and problem solving) effects on incidence of preeclampsia. Aim is to determine efficacy of social risks-focused lifestyle interventions on preeclampsia risk and reduce overall rates of preeclampsia in nulliparous, African-American women living in the inner city of Milwaukee.

Keywords: Pregnancy, Preeclampsia, Social determinants of health, prevention
Interventional Prematurity Risk Assessment Combined with Clinical Interventions for Improving Neonatal Outcomes (PRIME)

PI: Anna Palatnik, MD

A randomized PTB prevention strategy (PTB Prevention arm) or to standard of care management (Control arm). Subjects randomized to the preterm birth prevention strategy will receive either routine standard of care pregnancy management or a multimodal intervention protocol reserved for higher risk pregnancies based on the results of a commercially-available laboratory developed test, PreTRM® (Sera Prognostics, Inc). The intervention protocol utilizes well-established high-risk pregnancy interventions to improve maternal and neonatal health outcomes.

Keywords: pregnancy, preterm labor, preterm birth
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
ObservationalActivity in Women At Risk for Early delivery (AWARE)

PI: Anna Palatnik, MD

Keywords: Pregnancy, Short Cervix, Activity Level
InterventionalPreeclamptic Postpartum Antihypertensive Treatment (P-PAT)

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

PI: Anna Palatnik, MD

Keywords: Pregnancy, Pre-Eclampsia, Gestational Hypertension
InterventionalContinuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy (SLEEP)

A Randomized Trial of Continuous Positive Airway Pressure (CPAP) for Sleep Apnea in Pregnancy (SLEEP). It is a randomized controlled trial of 1,500 women to assess whether treatment of sleep disordered breathing with continuous positive airway pressure (CPAP) in pregnancy reduces the rate of hypertensive disorders of pregnancy

PI: Anna Palatnik, MD

Keywords: CPAP, Apnea, Pregnancy

Closed to Enrollment

Type of TrialProtocol ID & Study Title
Uterine FibroidsUterine Fibroids
Title: A Phase 2b Study to Evaluate the Safety and Efficacy of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Keywords: Uterine Fibroids, Heavy Bleeding, Elagolix
InterventionalProgenity PRO-104-Preeclampsia

PI: Anna Palatnik, MD

This sample collection study obtains blood and urine samples from pregnant women who present with clinical suspicion of preeclampsia. Samples will be used to evaluate and validate the performance of an assay intended to aid in assessing the risk of preeclampsia.

Keywords: Pregnancy, Pre-eclampsia, Hypertension
InterventionalAMAG-423-201

PI: Anna Palatnik, MD

A Phase 2b/3a, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of AMAG-423, a Digoxin Immune Fab, in Antepartum Subjects With Severe Preeclampsia

Keywords: Pregnancy, Pre-eclampsia

To obtain information regarding any gynecologic clinical trials that our department has open, please contact our research team at 1-855-771-9477 or Email Us.