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A trial in which Joseph Bell, MD, Section Chief of Maternal Fetal Medicine for St. Luke’s University Health Network (SLUHN) was a key participant has received the prestigious David Sackett Trial of the Year Award. The award is given by the Society for Clinical Trials (SCT) and presented at its 44th annual meeting held in Baltimore, Maryland, in late May.

The honored six-year research study in which obstetrician/gynecologist Dr. Bell participated was titled “Chronic Hypertension And Pregnancy (CHAP).” The trial evaluated the effects of prescribing blood pressure medication to pregnant people with mild chronic hypertension. With more than 2,408 randomized participants at 61 sites in the United States, CHAP is the largest and most diverse study of its kind, according to its nomination. Dr. Bell’s Maternal Fetal Medicine group enrolled the seventh largest number of patients of those centers participating in the study. 

Hypertension common in pregnancy

Chronic hypertension is a common medical disorder that causes life-threatening complications for pregnant people and their babies. At least 70% of pregnant people with chronic hypertension fall into the “mild” category for which there is no medical consensus on whether they should be treated with medications. The uncertainty stems primarily from concerns that treatments would affect the baby’s growth in the absence of proven benefits.

CHAP found a 20% decrease in pregnancy complications, including severe preeclampsia and preterm birth before 35 weeks for pregnant people with mild hypertension treated with medication compared to those who were not given treatment. No differences in newborn size or other outcomes were observed in pregnant people who were treated. CHAP resulted in a change in national guidelines.

Dr. Bell, who served as the principal investigator at St. Luke’s, said that the study is “groundbreaking” and that its conclusions “give us much-needed evidence and guidance for optimal care. Many women and their babies will benefit. Knowing from this research that medical management of this common condition is effective and safe is highly significant.”

Study published in NEJM in 2022

“Treatment for Mild Chronic Hypertension in Pregnancy” was published in May 2022 in the New England Journal of Medicine (NEJM). It also was presented at the American Cardiology Conference in Washington, D.C. by Alan Tita, MD, PhD, of the University of Alabama Birmingham, the national principal investigator for the study. Dr. Tita nominated the study for the award presented by the SCT.

Since 2008, SCT has awarded the David Sackett Trail of the Year Award to a randomized, controlled trial published in the previous calendar year that among other criteria improves the lot of humankind, reflects expertise in subject matter, and is consistent with the overall aims of the Society, which supports the goals of equity, diversity, and inclusion.

In her presentation, Suzanne Dahlberg, PhD, Chair of the SCT David Sackett Trial of the Year Committee, said, the CHAP trial of treatment for mild chronic hypertension during pregnancy is “most deserving of this competitive award.”