The LIONESS™ Study
LIONESS™: a novel investigational device designed to prevent preterm birth, studied at UTHealth Houston. Sponsored by PregnanTech.
For women less than 18 weeks pregnant
Check If You QualifyA previous preterm birth can raise concerns during a new pregnancy. Every additional week in the womb matters for a baby's growth.
The LIONESS™ is a novel device designed to prevent preterm birth: an elastic silicone ring placed high around the cervix by an OB-GYN, to give the cervix support during pregnancy.
The purpose of the LIONESS™ study is to learn whether the device may help prevent preterm birth in women who have had one before, and to learn more about its safety. It is an investigational device, studied in addition to standard medical care.
Taking part means that, in this pregnancy, you receive the LIONESS™ device in addition to your regular care, with close follow-up from an experienced medical team throughout, at no cost.
Regular follow-up and monitoring from an experienced medical team throughout pregnancy.
Every participant receives the LIONESS™ device in addition to standard medical care.
Study care is at no cost, and participants receive $50 for each study visit.
Study visits take place at UTHealth Houston, in the Texas Medical Center.
Checking takes about two minutes.
Check If You Qualify"When I found out I was pregnant for the second time, I was afraid of premature birth." A participant in an earlier LIONESS™ study
Hear from Dr. David Shashar, founder and CEO of PregnanTech, and from women who took part in an earlier LIONESS™ study.
The LIONESS™ is an elastic silicone ring placed high around the uterine cervix by an OB-GYN, in a short outpatient procedure between 14 and 18 weeks of pregnancy. It is designed to reduce the load on the cervix and help it stay long and closed. The LIONESS™ can be removed at any time.
LIONESS™ is an investigational device. This study is being done to learn about its safety and whether it works. LIONESS™ is not approved by the U.S. FDA for commercial marketing or sale.
Short online questionnaire about your pregnancy, then your contact details.
A call from nRollmed, the team that runs pre-screening for this study, to review eligibility and answer your questions. No obligation.
A visit with a study doctor at UTHealth Houston, with a full explanation of the study and a medical check. The study team explains the procedure, the visit schedule and the possible risks before you decide.
Follow-up during pregnancy. Every participant receives the device in addition to standard medical care, with regular study visits.
Less than 14 weeks pregnant? You can check now; the procedure is scheduled once you reach 14 to 18 weeks.
There is no cost to take part, and participants receive $50 for each study visit.
Findings from an earlier pilot study in women at high risk of preterm birth showed encouraging results. In that earlier pilot study, among participants with a history of preterm birth, the pregnancies with the LIONESS™ lasted, on average, approximately three weeks longer than their previous pregnancies. This study in Houston is being done to learn more.
UTHealth Houston
Larry Gilstrap M.D. Center for Perinatal and Women's Health | Department of Obstetrics, Gynecology and Reproductive Sciences
6431 Fannin Street | Houston, Texas 77030
Yes. There is no placebo group.
Yes. You can say no or leave at any time, and it will not affect your medical care. You keep your regular prenatal care, and your doctor can still recommend other treatment if needed.
No one can promise that. The device is investigational, and while results from an earlier pilot study have been encouraging, this study is designed to further evaluate whether it may help prevent preterm birth.
The study doctor will explain all known risks and possible side effects before you decide.
Only the study team and nRollmed, which runs pre-screening for the study, for this research, as described in the consent form and the privacy policy.
