Clinical Trial: Prolonged Treatment for Infected Abortion After Hospital Discharge.

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Hospital de Clinicas de Porto Alegre

Current Primary Outcome: Hospital re-admission [ Time Frame: 7 days after hospital discharge ]

Original Primary Outcome:

  • No fever
  • Minimal or abscent vaginal bleeding
  • Walking normally
  • Important decrease of the pain


Current Secondary Outcome:

  • minimal or absent vaginal bleeding [ Time Frame: 7 days after hospital discharge ]
  • walking normally [ Time Frame: 7 days after hospital discharge ]
  • important decrease of pain [ Time Frame: 7 days after hospital discharge ]
  • no fever [ Time Frame: 7 days after hospital discharge ]


Original Secondary Outcome:

Information By: Hospital de Clinicas de Porto Alegre

Dates:
Date Received: September 14, 2006
Date Started: May 2006
Date Completion:
Last Updated: March 10, 2008
Last Verified: December 2007