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The Use of Antibiotics After Hospital Discharge in Septic Abortion (APA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre

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.


Condition or disease Intervention/treatment Phase
Abortion, Septic Drug: placebo Drug: doxycycline plus metronidazole Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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)
Other Names:
  • Vibramicina
  • Flagyl

Placebo Comparator: 2
Patients that do not receive antibiotics, only placebo
Drug: placebo
placebo




Primary Outcome Measures :
  1. Clinical cure defined as no fever, no abdominal pain or bleeding. [ Time Frame: 10 days after hospital discharge ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients admitted at the hospital with a diagnosis of infected abortion and about to be discharged from the hospital.
  • Use of intravenous antibiotics (gentamicin and clindamycin)
  • Improvement of the clinical conditions for at least 48 hours (no fever, eating and walking normally, reduced vaginal bleeding)

Exclusion Criteria:

  • Unwilling to participate in the study.
  • Use of antibiotics previously within one week.
  • Presence of tubo-ovarian abscess.
  • Known allergy to doxycycline or metronidazole.

Information from the National Library of Medicine

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


Locations
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Brazil
Hospital de Clínias de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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Principal Investigator: Ricardo F Savaris, MD, PhD Hospital de Clínicas de Porto Alegre

Additional Information:
Publications:
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Responsible Party: Ricardo Francalacci Savaris, HCPA-UFRGS
ClinicalTrials.gov Identifier: NCT00353743    
Other Study ID Numbers: 05-452
GPPG 05-452
First Posted: July 19, 2006    Key Record Dates
Last Update Posted: December 19, 2008
Last Verified: March 2007
Keywords provided by Hospital de Clinicas de Porto Alegre:
infected abortion
treatment period
doxycycline
metronidazole
placebo
Additional relevant MeSH terms:
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Abortion, Septic
Pregnancy Complications, Infectious
Infection
Abortion, Spontaneous
Pregnancy Complications
Anti-Bacterial Agents
Metronidazole
Doxycycline
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Antiprotozoal Agents
Antiparasitic Agents
Antimalarials