CHAP trial awarded Clinical Trial of the Year

Results from the Chronic Hypertension and Pregnancy trial found treating preexisting mild chronic hypertension in pregnant women is safe from both the mom and baby. Results published in April 2022 have since led to changes in national guidelines.

titaAlan Tita, M.D., Ph.D.,
Photography: Dustin Massey
The Chronic Hypertension and Pregnancy trial, led by the University of Alabama at Birmingham, received the David Sackett Trial of the Year award from the Society for Clinical Trials. The prestigious award is given to a clinical trial that improves the lot of humankind and provides substantial and beneficial change to health care.  

The CHAP trial evaluated the effects of prescribing blood pressure medication to pregnant women with mild chronic hypertension. Results published in the New England Journal of Medicine in April 2022 showed treatment improved pregnancy outcomes without compromising the baby’s growth and overall health, which was a primary concern for physicians for years. CHAP results have since led to changes in national guidelines.

“Chronic hypertension causes serious and life-threatening complications for pregnant women and their babies,” said Alan Tita, M.D., Ph.D., professor of obstetrics and gynecology in the UAB Marnix E. Heersink School of Medicine, principal investigator for the CHAP trial, and lead author of the NEJM paper. “Between 70 percent and 80 percent of pregnant women with chronic hypertension fall into the ‘mild’ category, where there was not a medical consensus for treatment.” 

The CHAP consortium — including over 60 collaborating clinical sites across the United States, with clinical and data coordinating centers in the UAB departments of Obstetrics and Gynecology and Center for Women’s Reproductive Health and the department of Biostatistics in the School of Public Health — launched the CHAP program in 2014 with funding from the National Institutes of Health’s Heart, Lung and Blood Institute. From September 2015 to March 2021, CHAP enrolled more than 2,400 pregnant women with mild chronic hypertension whose blood pressure was greater than 140/90 mmHg but less than 160/105 mmHg.

Notably, the CHAP trial is one of the most comprehensive and diverse studies of its kind. The Black patient population is disproportionately affected by chronic hypertension, and almost 50 percent of study participants were Black mothers.

slide Treatment of Mild Chronic Hypertension in Pregnancy“The CHAP trial overcame multiple challenges before its successful conclusion,” said Jeff Szychowski, Ph.D., professor of biostatistics and principal investigator of the Data Coordinating Center for CHAP. “This award recognizes the tremendous efforts of the UAB team and our collaborators across the nation.”

Nominations for the David Sackett Trial of the Year were submitted by SCT members, investigators and interested scholars from around the world. Tita will present CHAP trial results and accept the award at the SCT annual meeting in Baltimore on May 24.

“This year, the SCT David Sackett Trial of the Year Committee was honored to review numerous global nominations of clinical trials spanning a wide variety of medical settings, including COVID-19, oncology, cardiology, obesity, diabetes, orthopedics and pregnancy,” said Suzanne Dahlberg, Ph.D., chair of the SCT David Sackett Trial of the Year Committee. “We are eager for Dr. Tita to present the details of his trial of treatment for mild chronic hypertension during pregnancy, a trial most deserving of this competitive award, and look forward to a lively discussion afterward.”

Read more about the CHAP trial here.