Official Title: “Prolonged Treatment for Infected Abortion After Hospital Discharge.”

Patients with infected abortion will be treated with dilatation and curettage, intravenous antibiotics. The purpose of this study is to verify if it is necessary to keep the use of oral antibiotics after hospital discharge.

Study Type: Interventional

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

Study Primary Completion Date: December 2007

The use of 7-10 days of treatment for infected/septic abortion is not based on clinical trials. A recent evidence showed that endometritis post cesarean section needs no treatment after hospital discharge. The objective of this study is to verify if this finding also applies to infected abortions.

After in hospital treatment, the patients will be randomized to the traditional treatment (metronidazole and doxycycline) or to placebo until 10 days of treatment is completed. Active follow-up will be done every 2 days, and the patient will be reevaluated at the end of treatment.

Cure will be defined as the absence of fever, pain and bleeding. Failure of treatment will be considered as the need for hospitalization or additional antibiotics.

Intervention(s) in this Clinical Trial

• Drug: metronidazole and doxycycline
  • use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Use of antibiotics after hospital discharge
• Placebo Comparator: 2
  • Use of placebo

Primary Measures

• Hospital re-admission
  • Time Frame: 7 days after hospital discharge
    Safety Issue?: Yes

Secondary Measures

• minimal or absent vaginal bleeding
  • Time Frame: 7 days after hospital discharge
    Safety Issue?: Yes
• walking normally
  • Time Frame: 7 days after hospital discharge
    Safety Issue?: Yes
• important decrease of pain
  • Time Frame: 7 days after hospital discharge
    Safety Issue?: Yes
• no fever
  • Time Frame: 7 days after hospital discharge
    Safety Issue?: Yes

Inclusion Criteria:

• History of intrauterine manipulation with contaminated objects.
• Vaginal secretion with fetid odor
• Presence of pus flowing through the cervical uterine
• Presence of peritonitis
• Leucocytosis (> 14,000 leucocytes/mL)
• Vasodilatation, bounding pulse and paradoxically warm periphery with tachycardia (Heart rate> 110 bpm)
• Cyanosis and/or paleness
• tachypnea(> 30mpm)
• Arterial hypotension (SAP< 90mmHg)
• Oliguria
• Fever (> or = than 37,8°C)

Exclusion Criteria:

• Refusal to participate in the project
• Prior use of antibiotics within one week
• Known allergy to Doxycycline or Metronidazole
• Presence of tubo-ovarian abscess

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 14 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 October 07, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00376493

Study ID Number: APA 05-452

ClinicalTrials.gov Identifier: NCT00376493

Health Authority: Brazil: Ministry of Health