NCT01194115 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Elyan A, Mahran M, el-Maraghy M, Abou-Seeda M
Prophylactic intravenous metronidazole in cesarean section. Chemioterapia. 1984 Feb;3(1):67-70.
Hofmeyr GJ, Smaill FM
WITHDRAWAN. Antibiotic prophylaxis for cesarean section. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD000933. doi: 10.1002/14651858.CD000933.pub2. Review.
Meyer NL, Hosier KV, Scott K, Lipscomb GH
Cefazolin versus cefazolin plus metronidazole for antibiotic prophylaxis at cesarean section. South Med J. 2003 Oct;96(10):992-5.
Robinson HE, O'Connell CM, Joseph KS, McLeod NL
Maternal outcomes in pregnancies complicated by obesity. Obstet Gynecol. 2005 Dec;106(6):1357-64.
Tita AT, Owen J, Stamm AM, Grimes A, Hauth JC, Andrews WW
Impact of extended-spectrum antibiotic prophylaxis on incidence of postcesarean surgical wound infection. Am J Obstet Gynecol. 2008 Sep;199(3):303.e1-3. doi: 10.1016/j.ajog.2008.06.068.

Use of 48 Hour Course of Antibiotics to Prevent Surgical Site Infection in Obese Patients Undergoing Cesarean Delivery

Clinical trial NCT01194115 - References