SLUCare obstetricians are leading a clinical trial at SSM Health St. Mary's Hospital that investigates a possible approach to treat postpartum hemorrhage, the leading cause of perinatal maternal death around the world.
The research is being conducted at SSM Health St. Mary's Hospital, the first of eight clinical sites to test the InPress Postpartum Hemorrhage Intrauterine device.
"The potential benefits of the InPress device are numerous," said Gilad Gross, M.D., director of the maternal-fetal medicine division at Saint Louis University School of Medicine and principal investigator of the study. "It mimics the body's physiologic response to halt bleeding following childbirth healing without the need for medications, hysterectomy or other surgical procedures."
"If successful, this treatment approach could significantly reduce the cost of care and has the potential to reduce the risk of hysterectomy or death," said Gross, who also is a SLUCare physician.
Postpartum hemorrhage is excessive bleeding in a mother after childbirth. In 80 percent of incidents, postpartum hemorrhage occurs when the uterus fails to contract following childbirth. With the blood vessels left fully dilated, heavy blood loss can occur quickly.
In these cases, the first line of treatment is typically oxytocin – a medication that helps the uterus contract. If the bleeding continues, treatment options include additional medications, an intrauterine balloon, which inflates within the uterus putting pressure on bleeding vessels; uterine artery embolization, which blocks blood supply to the uterus; and hysterectomy. These treatments are time consuming and combined with additional surgery can lead to life threatening blood loss.
The InPress device works differently. The vacuum-powered device assists the body's natural response after childbirth by gently contracting the uterus which promotes cessation of blood loss. The single-use silicone device is inserted into the uterus and attached to vacuum suction readily available in hospital rooms.
A small, 10 person trial was conducted in Indonesia in 2014 and 2015. In each case, the InPress device quickly stopped the hemorrhage, usually in a matter of minutes.
"If this trial is successful, it could change the way postpartum hemorrhage is treated around the world and potentially save many lives, especially in developing countries where the risk of death is greater," Gross said.
The postpartum hemorrhage intrauterine device is made by InPress Technologies, a startup medical device company created by two biomedical engineers from California Polytechnic State University. InPress Technologies was a company-in-residence at the Fogarty Institute for Innovation, which serves as a catalyst for medical device innovation.