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Prolonged Treatment for Infected Abortion After Hospital Discharge. (APA)
This study has been terminated.
( The rate of cure in both arms was higher than expected )
Study NCT00376493   Information provided by Hospital de Clinicas de Porto Alegre
First Received: September 14, 2006   Last Updated: March 10, 2008   History of Changes

September 14, 2006
March 10, 2008
May 2006
December 2007   (final data collection date for primary outcome measure)
Hospital re-admission [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]
  • No fever
  • Minimal or abscent vaginal bleeding
  • Walking normally
  • Important decrease of the pain
Complete list of historical versions of study NCT00376493 on ClinicalTrials.gov Archive Site
  • minimal or absent vaginal bleeding [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]
  • walking normally [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]
  • important decrease of pain [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]
  • no fever [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]
Same as current
 
Prolonged Treatment for Infected Abortion After Hospital Discharge.
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.

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.

Phase IV
Interventional
Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Septic Abortion
Drug: metronidazole and doxycycline
  • Active Comparator: Use of antibiotics after hospital discharge
  • Placebo Comparator: Use of placebo

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
56
December 2007
December 2007   (final data collection date for primary outcome measure)

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
Female
14 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00376493
Ricardo Francalacci Savaris, Hospital de Clínicas de Porto Alegre
APA 05-452
Hospital de Clinicas de Porto Alegre
Fundo de Incentivo a Pesquisa (FIPE-HCPA)
Principal Investigator: Ricardo F Savaris, MD, PhD Hospital de Clínicas de Porto Alegre
Principal Investigator: Adriani O Galão, MD, PhD Hospital de Clínicas de Porto Alegre
Hospital de Clinicas de Porto Alegre
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP