The Use of Antibiotics After Hospital Discharge in Septic Abortion (APA)
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|ClinicalTrials.gov Identifier: NCT00353743|
Recruitment Status : Terminated (Rate of cure was higher than expected, IRB suspended for no additional benefit)
First Posted : July 19, 2006
Last Update Posted : December 19, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Abortion, Septic||Drug: placebo Drug: doxycycline plus metronidazole||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||56 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized Clinical Trial on the Use or Not of Antibiotics After Hospital Discharge in Septic Abortion.|
|Study Start Date :||May 2006|
|Actual Primary Completion Date :||November 2007|
|Actual Study Completion Date :||December 2007|
Active Comparator: 1
Patients that receive up to 10 days of doxycycline 200mg/day and metronidazole 500mg/day
Drug: doxycycline plus metronidazole
doxycycline 200mg/day plus metronidazole 500mg/day up to 10 days of treatment (additional to the hospital treatment)
Placebo Comparator: 2
Patients that do not receive antibiotics, only placebo
- Clinical cure defined as no fever, no abdominal pain or bleeding. [ Time Frame: 10 days after hospital discharge ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353743
|Hospital de Clínias de Porto Alegre|
|Porto Alegre, Rio Grande do Sul, Brazil, 90035-003|
|Principal Investigator:||Ricardo F Savaris, MD, PhD||Hospital de Clínicas de Porto Alegre|