Dr. Kim Boggess, professor for the Department of Obstetrics and Gynecology’s Division of Maternal Fetal Medicine, has been administering the study Cesarean Section Optimal Antibiotic Prophylaxis.
Karen Dorman, RN MS, has been assisting Boggess on the study. She says women who receive cesarean sections are at risk for developing a postpartum infection either in their uterus, endometritis, or in their wound, a wound infection. Despite being given an antibiotic routinely, ten percent of women still get an infection.
“This study is to see if adding another antibiotic, in addition to the cephalosporin will decrease the occurrence of infection,” Dorman stated. “Thus it is a randomized, double blind, placebo controlled trial in which all women are given the routine AB and then they are randomized to either azithromycin or placebo. It is blinded since no one knows which study medication they are getting. Azithromycin covers mycoplasma – which is another organism, which may be the cause of other infections.”
The study is still recruiting participants and has yet to enroll half their targeted subjects. The original projected end date of July 31, 2013 has been extended with a no cost extension in order to reach their participation goal of 2000 before beginning data analysis. Dorman stated that their slow recruitment has been one of the biggest challenges they have faced.
“Many Cesarean Sections (C/S’s) in labor and delivery (L/D) are done for non reassuring fetal heart rate tracing – sort of an urgent, if not emergent situation and there is no time to consent,” Dorman explained. “We would love to consent all patients when they arrive in L/D – but the staff are concerned that we immediately cast doubt on the patient’s ability to deliver vaginally if we start talking about a C/S study.”
The end date is to be decided and the study is administered by the Center for Women’s Health Research at UNC.