The Midwest Fetal Care Center (MWFCC), a collaboration between Allina Health and Children’s Minnesota, is taking part in two studies aimed at improving outcomes for fetuses with high-risk conditions.
Azalea Trial
The Azalea Trial assesses the efficacy of administering the drug Nipocalimab in pregnancies affected by hemolytic disease of the fetus and newborn (HDFN). Nipocalimabis given as an intravenous immunoglobulin (IVIG), a type of therapy used to treat immune deficiencies and inflammatory conditions. HDFN is a blood disorder that causes the baby’s red blood cells to break down quickly. HDFN occurs when the blood types of the mother and fetus are incompatible, causing severe fetal anemia. HDFN is typically treated via intrauterine transfusion.
“This procedure has a significant fetal loss rate, especially early in gestation,” said Saul Snowise, MD, medical director of the MWFCC. “In early non-randomized studies (Phase II Trial), Nipocalimab has been shown to improve fetal outcomes and significantly prevent the need for fetal transfusions in patients with a history of pregnancies severely affected by HDFN.”
The Azalea Trial is now accepting patients at the MWFCC. The MWFCC has randomized 2 of the 11 patients currently in the study in the U.S. The trial aims to enroll 120 patients at advanced fetal care centers worldwide.
GOOD Study
The GOOD Study is conducting research on gastroschisis, which occurs when a fetus has a total defect in the anterior abdominal wall. The defect is typically discovered during routine antenatal ultrasound screening around the 20th week of pregnancy. Fetuses with gastroschisis have a higher incidence of growth restriction and require closure of the defect after delivery.
“The GOOD Study is an NIH-funded study designed to assess if early delivery can improve some of these suboptimal outcomes and if antenatal markers can be identified that may predict more complicated neonatal courses,” said Dr. Snowise.
The GOOD Study is ongoing at select centers within the North American Fetal Therapy Network and the MWFCC has randomized nine patients to this important multicenter study.
Learn more about research at the Midwest Fetal Care Center.
