MCW Team Leads Pediatric Study

MCW and health system partner Children’s Wisconsin are on the vanguard of best practices for gastroschisis, the most common congenital abdominal wall abnormality in developing fetuses.

This birth defect, in which the intestines are outside the body floating in the amniotic fluid, is diagnosed by prenatal ultrasound at 18-20 weeks gestation. During fetal development, the abdominal wall fails to close properly, leaving an opening which is usually to the right of the umbilical cord.

Gastroschisis affects one out of every 4,000 births – and the number of cases continues to increase. Experts do not know what causes gastroschisis, but it is associated with younger maternal age and rarely occurs in mothers over 30 years of age. Gastroschisis is treated immediately after birth with surgery to put the organs back into the baby’s body. Often, these tiny patients need additional treatments, such as receiving nutrients through an IV line and antibiotics. As importantly, attention must be paid to their body temperature.

Some doctors believe pregnancies complicated by gastroschisis should deliver early, while others think that mothers should carry their babies until the onset of labor. Unfortunately, there is no definite answer regarding whether a mother carrying a baby with gastroschisis should deliver early or carry the baby closer to term, and no scientific data exists to show if one delivery method is better than the other. Additionally, babies with gastroschisis are at an increased risk for being stillborn, and their intestines may be damaged while in the amniotic fluid.

A piece of “good” news is that research is now underway that could help the health of babies diagnosed with gastroschisis. The Gastroschisis Outcomes of Delivery (GOOD) Study, which comprises 26 participating centers across North America, will help doctors determine the best time to deliver a baby with gastroschisis and will help the infant live as healthy as possible post-birth.

The GOOD Study began nationally in February 2018 and had its genesis in a 2016 seed grant from the We Care Fund for Medical Innovation and Research in MCW’s department of surgery that was awarded to Amy Wagner, MD ’01, FEL ’11, professor of pediatric surgery at MCW.

The success of the study and Dr. Wagner’s leadership resulted in the receipt in April 2021 of a five-year, $4.2 million grant from the Eunice Kennedy Shriver National Institute of Child Health & Human Development to continue research on the outcomes of babies born with gastroschisis. Dr. Wagner is the principal investigator on the grant and oversees all 26 participating centers. Aniko Szabo, PhD, professor in MCW’s Institute for Health & Equity, has been working alongside Dr. Wagner from the beginning of the GOOD Study. Other MCW faculty working with Dr. Wagner include Erika Peterson, MD, professor of obstetrics and gynecology (maternal-fetal medicine) and Steven Leuthner, MD, MA, professor of pediatrics (neonatology).

MCW and Children’s Wisconsin are home to the Data Coordinating Center for the study, which is designed to answer the question: Should moms of babies with gastroschisis deliver early or carry their babies closer to term? A clinical trial is currently underway to investigate the hypothesis that delivery at 35 0/7 - 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks.

“The GOOD Study has potential to affect the lives of the thousands of mothers and infants diagnosed with gastroschisis every year,” Dr. Wagner says. By the conclusion of the study in 2025, the team expects that its research efforts will have made a significant and positive difference in the quality of life for these tiniest of patients and their families.

– Elizabeth Karnowski