Clinical Trial: The Use of Antibiotics After Hospital Discharge in Septic Abortion
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Randomized Clinical Trial on the Use or Not of Antibiotics After Hospital Discharge in Septic Abortion.
Brief Summary:
The use of antibiotics in post-partum infection has been abbreviated. After 48 hours of clinical improvement, the patient is discharged from the hospital without antibiotics. No trials has been found in cases of septic abortion.
The purpose of the present study is to verify the need of antibiotics after clinical improvement in cases of septic abortion.
Detailed Summary:
Septic abortion is still a major cause of maternal mortality in developing countries. According to the WHO, 1 woman dies for every 270 illegal abortion (Ahman E, 2004). Infected abortion has an important role in maternal morbidity and mortality (Stubblefield PG, 1994). the diagnosis of infected abortion must be considered when a patient presents a history of delayed menses, vaginal bleeding, abdominal pain and fever (Brasil, 2000)
Prompt diagnosis and treatment are paramount steps to prevent complications. At Hospital de Clínicas de Porto Alegre, the use of gentamycin plus clindamicin before curettage is preconized (Savaris R, 2006). Nevertheless, the time of treatment it is not well established, varying from 7-14 days (Brasil, 2000).
A recent study with post-partum endometritis has shown that it is not necessary to extend the treatment to 14 days, after clinical improvement (Turnquest MA, 1998; French LM, 2004)
A randomized clinical trial comparing placebo with the standard protocol of treatment would define weather both treatments are equivalent or not.
Comparison: The prolonged use of antibiotics, after intravenous use of antibiotics and clinical improvement, will be compared to the use of placebo in cases of septic abortion.
Sample size and ethical issues The study protocol was approved by the ethics committee of Hospital de Clínicas de Porto Alegre.
To compare equivalence between the 2 treatments we calculated the sample size considering an alpha error of 0.05, a beta error of 0.1, and difference between the two groups of no more than 10%. We expected a 99% clinical cure with the standard protocol, and 95% for t
Sponsor: Hospital de Clinicas de Porto Alegre
Current Primary Outcome: Clinical cure defined as no fever, no abdominal pain or bleeding. [ Time Frame: 10 days after hospital discharge ]
Original Primary Outcome: Clinical cure defined as no fever, no abdominal pain or bleeding.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Hospital de Clinicas de Porto Alegre
Dates:
Date Received: July 13, 2006
Date Started: May 2006
Date Completion:
Last Updated: December 18, 2008
Last Verified: March 2007
