(from left) Amelia Degenkolb, CEO and Co-Founder, Novocuff, Inc., Amanda Urban, Lisa Zuckerwise, Kristin Atkins, and Kathryn Wine, Vice President of Clinical Affairs, Novocuff, Inc., during the site visit at UVA.
Lisa Zuckerwise, MD, is an associate professor in the Department of Obstetrics and Gynecology and division director of the Maternal-Fetal Medicine Program at the University of Virginia. She is the national co-PI and UVA site principal investigator for a randomized trial designed to evaluate the use of the Novocuff Cervical Control System in the treatment of pregnant patients with preterm premature rupture of membranes (PPROM). The study, called the RETAIN Study, will be submitted to the U.S. Food and Drug Administration (FDA) for approval under an Investigational Device Exemption.
PPROM, which is when a patient’s amniotic sac ruptures in the preterm period, is one of the leading causes of preterm birth, and can have serious maternal and neonatal consequences. Current standard management of PPROM includes a course of antibiotics to prolong pregnancy, “latency antibiotics,” and inpatient expectant management until delivery is indicated by either gestational age, maternal complication, fetal complication, or onset of preterm labor.
Lisa Zuckerwise, MD
The RETAIN Study aims to evaluate the effectiveness of a cervical closure device to restore amniotic fluid volume and prolong pregnancy, and thus potentially reduce maternal, fetal, and neonatal morbidity. The study will be randomized, meaning it’s designed to compare the use of the device in addition to the usual standard of care to the use of latency antibiotics alone. The safety evaluation will include both maternal and fetal/neonatal outcomes.
In this installment of our series “A Healthier Future — One Clinical Trial at a Time,” Dr. Zuckerwise shares more about the RETAIN Study and its impact on pregnant patients with PPROM.
Q. What do you hope to learn from this study? Will the results potentially change the standard of care for future patients?
Zuckerwise: We hope to learn if the Novocuff Cervical Control System (a medical device) can help to retain amniotic fluid and safely prolong pregnancy in pregnant patients with PPROM, beyond the current average latency period of 6-7 days. We also plan to study effects of the device on amniotic fluid volume, obstetric outcomes including mode of delivery, and neonatal outcomes related to potentially higher amniotic fluid volumes and later ages at delivery.
If the device is shown to be beneficial for use in this serious medical condition, it could change the way we treat patients for PPROM who are hospitalized for their condition.
Q. Does your trial give novel treatment or other opportunities to your/our patients?
Zuckerwise: There is no available evidence-supported strategy or device to restore amniotic fluid volume in patients following PPROM. The Novocuff Cervical Control System is a novel approach to potentially restore amniotic fluid and prolong pregnancy after PPROM. This device will only be available for use in the RETAIN Study once the trial is approved by the U.S. FDA and the overseeing IRB. The device is otherwise not available for use.
Q. What is novel about your study design/treatment/intervention?
Zuckerwise: Today, pregnant patients with PPROM at a viable gestational age are hospitalized and given a regimen of antibiotics that has been shown to prolong latency between PPROM and delivery; however, there is not a viable option for restoring amniotic fluid volume after membrane rupture. Amniotic fluid is critical during early and mid-pregnancy to allow for fetal lung development, and throughout pregnancy for normal anatomical and neuromuscular development. The hope with this study is to identify a new treatment option in treating patients with PPROM where the patient can remain pregnant safely and the baby can continue to grow and develop in utero.
Q. How will you ensure inclusion of a diverse subject population?
Zuckerwise: The study is expected to enroll a diverse subject population given the geographic diversity of planned clinical trial sites spanning the U.S., inclusion of non-English speaking patients through availability of translated patient materials (like consent forms and questionnaires), and inclusive imagery in study materials.
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