Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00353743
Status:
TERMINATED
Last Update Posted:
2008-12-19
First Post:
2006-07-13
Brief Title:
The Use of Antibiotics After Hospital Discharge in Septic Abortion
Sponsor:
Hospital de Clinicas de Porto Alegre
Organization:
Hospital de Clinicas de Porto Alegre
Study Overview
Official Title:
A Randomized Clinical Trial on the Use or Not of Antibiotics After Hospital Discharge in Septic Abortion
Status:
TERMINATED
Status Verified Date:
2007-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Rate of cure was higher than expected IRB suspended for no additional benefit
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APA
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
The purpose of the present study is to verify the need of antibiotics after clinical improvement in cases of septic abortion
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 005 a beta error of 01 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 Students t-test Mann-Whitney test and Fishers 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
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 005 a beta error of 01 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 Students t-test Mann-Whitney test and Fishers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GPPG 05-452 | None | None | None |