Official Title: “A Randomized Clinical Trial on the Use or Not of Antibiotics After Hospital Discharge in Septic Abortion.”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study

Study Primary Completion Date: November 2007

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.

Intervention(s) in this Clinical Trial

• Drug: placebo
  • placebo
• Drug: doxycycline plus metronidazole
  • doxycycline 200mg/day plus metronidazole 500mg/day up to 10 days of treatment (additional to the hospital treatment)

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Patients that receive up to 10 days of doxycycline 200mg/day and metronidazole 500mg/day
• Placebo Comparator: 2
  • Patients that do not receive antibiotics, only placebo

Primary Measures

• Clinical cure defined as no fever, no abdominal pain or bleeding.
  • Time Frame: 10 days after hospital discharge
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hospital de Clinicas de Porto Alegre

Overall Clinical Trial Officials and Contacts

Ricardo F Savaris, MD, PhD Principal Investigator Hospital de Clínicas de Porto Alegre  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00353743

Study ID Number: APA

ClinicalTrials.gov Identifier: NCT00353743

Health Authority: Brazil: Ministry of Health

location of the study