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)
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT00376493
First received: September 14, 2006
Last updated: March 10, 2008
Last verified: December 2007
  Purpose

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.


Condition Intervention Phase
Septic Abortion
Drug: metronidazole and doxycycline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prolonged Treatment for Infected Abortion After Hospital Discharge.

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Hospital re-admission [ Time Frame: 7 days after hospital discharge ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 56
Study Start Date: May 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Use of antibiotics after hospital discharge
Drug: metronidazole and doxycycline
use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days
Placebo Comparator: 2
Use of placebo
Drug: metronidazole and doxycycline
use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   14 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376493

Locations
Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Investigators
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
  More Information

Publications:
Responsible Party: Ricardo Francalacci Savaris, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT00376493     History of Changes
Other Study ID Numbers: APA 05-452
Study First Received: September 14, 2006
Last Updated: March 10, 2008
Health Authority: Brazil: Ministry of Health

Keywords provided by Hospital de Clinicas de Porto Alegre:
Abortion
Infection
Antibiotics
Treatment
Pregnancy complications

Additional relevant MeSH terms:
Abortion, Septic
Pregnancy Complications, Infectious
Infection
Abortion, Spontaneous
Pregnancy Complications
Anti-Bacterial Agents
Doxycycline
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 28, 2014