Randomized Clinical Trial of Extended Spectrum Antibiotic Prophylaxis With Coverage for Ureaplasma urealyticum to Reduce PostCesarean Delivery Endometritis

Andrews, William W. PhD, MD; Hauth, John C. MD; Cliver, Suzanne P.; Savage, Karen BSN; Goldenberg, Robert L. MD

Obstetrics & Gynecology:
Original Research
Abstract

OBJECTIVE: To determine if extended spectrum prophylactic antibiotic treatment (with efficacy against Ureaplasma urealyticum) reduces post–cesarean delivery clinical endometritis.

METHODS: After cord clamping at cesarean delivery, subjects received prophylaxis with cefotetan. Subjects were then simultaneously randomized (double blind) to receive doxycyline plus azithromycin versus placebo. Post–cesarean delivery endometritis was defined clinically as fever of 100.4F or higher with one or more supporting clinical signs or a physician diagnosis of endometritis plus the absence of a nonpelvic source of fever.

RESULTS: A total of 597 women were enrolled, 301 in the doxycycline/azithromycin group and 296 in the placebo group. The study population was 56% black, 25.5 ± 6.2 years of age, and 43% nulliparous. The groups were similar (P > .05) for black race, parity, maternal age, and most risk factors for post–cesarean delivery endometritis. The frequency of post–cesarean delivery endometritis (16.9% versus 24.7%, P = .020), wound infections (0.8% versus 3.6%, P = .030), and a combination of these two outcomes (19.0% versus 27.8%, P = .019) were significantly lower in the doxycycline/azithromycin group compared with the placebo-treated group. The doxycycline/azithromycin versus placebo groups were dissimilar for maternal leukocytosis (24.9% versus 12.5%, P = .042) and frequency of classic uterine incision (7.6% versus 12.5%, P = .048). Adjusting for these factors did not alter the risk ratio for post–cesarean delivery endometritis in the active versus placebo-treated group (relative risk 0.65, 95% confidence interval 0.43, 0.98). Length of stay was longer in the placebo group overall (104 ± 56 versus 95 ± 32 hours, P = .016) and among women with endometritis (146 ± 52 versus 127 ± 46 hours, P = .047).

CONCLUSION: Extended spectrum prophylactic antibiotic treatment (with presumed efficacy against U urealyticum) given to women undergoing cesarean delivery at term shortens hospital stay and reduces the frequency of post–cesarean delivery endometritis and wound infections.

In Brief

Extended spectrum prophylactic antibiotic treatment given at cesarean delivery shortens hospital stay and reduces the frequency of post–cesarean delivery endometritis and wound infections.

Author Information

Division of Maternal–Fetal Medicine, Department of Obstetrics and Gynecology, Center for Research in Women's Health, University of Alabama at Birmingham, Birmingham, Alabama.

Address reprint requests to: William W. Andrews, PhD, MD, University of Alabama at Birmingham, Department of Obstetrics and Gynecology, OHB 452, 619 19th Street South, Birmingham, AL 35249-7333; E-mail: wandrews@uab.edu.

Azithromycin and placebo capsules were provided by Pfizer Pharmaceuticals, Groton, Connecticut.

Received September 4, 2002. Received in revised form December 3, 2002. Accepted December 12, 2002.

© 2003 The American College of Obstetricians and Gynecologists