At the SSM Health St. Louis Fetal Care Institute at SSM Health Cardinal Glennon Children's Hospital, clinical research plays an important role in what we do. Research makes it possible for us to offer some of the most advanced diagnostic procedures and treatments.
Types of Research
The St. Louis Fetal Care Institute participates in a variety of research programs that involve pregnant women, and their babies before and after they are born. We are also part of the North American Fetal Therapy Network (NAFTNet), which allows us to participate in collaborative research with other fetal care and surgery centers around the world. We use the data from these studies to improve patient care and to develop new fetal treatments.
The St. Louis Fetal Care Institute offers some fetal therapies that are in the early research stage. Often these therapies help patients who otherwise have few or no options for intervention.
Our research studies follow strict guidelines and procedures and have gained approval from the Saint Louis University Institutional Review Board (IRB) and SSM Health before they are initiated. An IRB is a committee composed of scientists and non-scientists who serve as advocates for human subjects in research. The IRB is tasked with the responsibility of reviewing and overseeing research projects.
Involvement In a Research Study
By participating in a research study you play a role in improving care for families who are in a similar situation to yours. The information learned from your participation will be used to help develop new diagnostic, treatment, and fetal care techniques.
Research studies have strict guidelines for who may participate in a study. If you are eligible for, and decide to participate in a research study at the St. Louis Fetal Care Institute there are a few important things to know:
- Ask questions: learn about the study and ask as many questions as you need to feel comfortable
- It’s your choice: being involved with a research study is completely voluntary
- You can leave the study: if you join a study you may stop participating at any time
- There are no promises: research changes over time and there is no guaranteed outcome from participating in a study
One of our research nurses will work with you and your family throughout the research process, which may extend beyond the delivery of your baby. The research team will discuss details of the study, and answer any questions.
After meeting with them you will know:
- Why the research is being conducted
- Details about the study and how it is being conducted
- The possible risks or benefits to you or your baby
- Other options that may be available instead of participating in the study
- How you and your baby’s health information will be treated during the study and after it is completed
- If you will incur any costs by participating in the study
- Who you can contact if you have any additional questions, or need more information about the study
- How you can find out about the results of the study
Myelomeningocele Screening and Outcomes after Open Fetal Surgery
Myelomeningocele (MMC), one of the most severe forms of spina bifida, is a condition where the fetus’ spinal cord fails to close during development. The Management of Myelomeningocele Study (MOMS) trial began in 2003 to determine if surgery before babies are born for MMC was better than surgery after birth. The goal was to enroll 200 women, but the trial was stopped early in December 2010 because there was clear evidence of the benefits of prenatal surgery. At the St. Louis Fetal Care Institute, open fetal surgery is an option for some mothers and their MMC babies. All mothers referred to the St. Louis Fetal Care Institute will meet with a Maternal Fetal Medicine Doctor, Neurosurgeon, Neonatologist, Anesthesiologist, Social Worker, Spina Bifida team member, Urologist, and a Fetal Care Institute nurse. An ultrasound, MRI and fetal echocardiogram will be done to evaluate the fetus.
Information is collected when evaluating the mother and baby for possible fetal surgery and throughout their care. This information can be inputed into two databases. One is the St. Louis Fetal Care Institute database. The second is the North American Fetal Therapy Network (NAFTnet) Fetal Myelomeningocele Repair Registry, which collects information throughout North America about babies and children with spina bifida who have had surgery before or after birth. Learn More.
Myelomeningocele Repair with Increased BMI
The Management of Myelomeningocele Study (MOMS) trial began in 2003 to determine if surgery for myelomeningocele or spina bifida before babies are born was better than waiting for the baby to be born and repairing the spina bifida after birth. The goal was to enroll 200 women, but the trial was stopped early in December 2010 because there was clear evidence of the benefits of prenatal surgery. Surgery before the baby is born is now common practice. Mothers who are heavier have a higher Body Mass Index (BMI). For mothers with a BMI greater than 34.9, fetal surgery has not been an option. Mothers in this weight range have never been studied. The Fetal Care Institute wants to study mothers with a BMI of 35-40. Learn More.
Women who have fetal surgery before their baby is born to repair fetal myelomeningocele undergo a hysterotomy, an incision on the uterus. After surgery has been performed on the mother and baby, the baby remains in the uterus to grow. The purpose of this study is evaluate the hysterotomy site six months or more after the baby is born to see how well the surgical site has healed. Learn More.
Alpha fetal protein (AFP)/Acetylcholinesterase (AChE) in Amniotic Fluid on Open Neural Tube Defects (ONTD)—Pregnancy of Mothers having open fetal repair
Alpha fetal protein (AFP) and Acetylcholinesterase (AChE) are levels detected in a mother’s blood stream and in amniotic fluid that can predict fetal spina bifida, which is another name for a baby’s open neural tube defect. The Fetal Care Institute wants to measure these levels of AFP and AChE during pregnancy. It is theorized that if a baby’s spina bifida is fully repaired in the womb, these levels will drop. The purpose of this study is to understand if these lab measures can predict complete closure vs. partial closure of a baby’s spina bifida repair before birth. Learn more.
North American Fetal Therapy Network (NAFTNet) Complicated Monochorionic Twin Pregnancy Registry
The Fetal Care institute is currently enrolling patients to voluntarily participate in the NAFTNet Complicated Monochorionic Twin Pregnancy Registry. The purpose of the registry is to collect information related to complicated monochorionic twin pregnancies to help us, along with NAFTNet, monitor the effectiveness of our current treatments. Learn More.
International Fetal Cardiac Intervention Registry (IFCIR)
The International Fetal Cardiac Intervention Registry (IFCIR) was established to improve the quality and outcomes of health care for fetal cardiac intervention candidates. This secure registry, developed by University of California, San Francisco, stores information about pregnant mothers and their babies’ diagnoses with certain congenital heart problems. Nearly 5,000 mothers and babies worldwide are estimated to take part in the study. The Fetal Care Institute is currently enrolling participants for the study. Learn More.
The Utility of MRI Scoring to Predict Neurodevelopmental Outcomes in Survivors of Twin-to-Twin Transfusion Syndrome
Treating Twin-to-Twin Transfusion Syndrome (TTTS) with laser surgery has been shown to be very effective at improving the survival for one or both twins. However, TTTS which is severe enough to require laser surgery is associated with a known risk of brain injury and developmental delays, particularly if only one twin survives. The St. Louis Fetal Care Institute and SSM Health Cardinal Glennon Children’s Hospital have developed a protocol to follow and monitor survivors of TTTS. As part of this protocol, a brain MRI is performed on all TTTS survivors near their due date to evaluate for signs of brain injury. The infant(s) return to the Cardinal Glennon Nursery Follow-up Clinic for physical therapy evaluations and developmental testing periodically throughout the first three years of life. Learn More.