The Use of Antibiotics After Hospital Discharge in Septic Abortion (APA)
Tracking Information | |||||
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First Received Date ICMJE | July 13, 2006 | ||||
Last Updated Date | December 18, 2008 | ||||
Start Date ICMJE | May 2006 | ||||
Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Clinical cure defined as no fever, no abdominal pain or bleeding. [ Time Frame: 10 days after hospital discharge ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE |
Clinical cure defined as no fever, no abdominal pain or bleeding. | ||||
Change History | Complete list of historical versions of study NCT00353743 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | The Use of Antibiotics After Hospital Discharge in Septic Abortion | ||||
Official Title ICMJE | 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. |
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Detailed Description | 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 the alternative one. These figures yield a minimum of 42 patients in each group. Interim analysis will performed at 58 for possible early stopping, if clinical cure was < 95%, or for sample size re-estimation. Randomization and treatment Subjects will be allocated in blocks of four at a time to create the allocation sequence. If the patient was eligible for the study, she will be allocated to one of the 2 treatments. The allocation will be concealed, coded and obtained from a central telephone number. Patients and those who assessed the outcomes were blind to group assignment. To avoid bias, both medications were manipulated by the hospital pharmacy and put in identically coded blisters and capsules. Statistical analysis Student´s t-test, Mann-Whitney test, and Fisher´s exact test will be used for statistical analysis. The rates of cure were analyzed by "modified" intention to treat (Keech AC, 2003) and per protocol with 95% confidence intervals. |
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Study Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Abortion, Septic | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Terminated | ||||
Enrollment ICMJE | 56 | ||||
Completion Date | December 2007 | ||||
Primary Completion Date | November 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Female | ||||
Ages | 18 Years to 50 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | Brazil | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00353743 | ||||
Other Study ID Numbers ICMJE | 05-452, GPPG 05-452 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Ricardo Francalacci Savaris, HCPA-UFRGS | ||||
Study Sponsor ICMJE | Hospital de Clinicas de Porto Alegre | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Hospital de Clinicas de Porto Alegre | ||||
Verification Date | March 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |