Prolonged Treatment for Infected Abortion After Hospital Discharge.

Phase 4

Terminated

• Conditions: Septic Abortion
• Interventions: Drug: metronidazole and doxycycline

• Registration Number: NCT00376493
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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 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.

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2006-09-14
• Study First Submitted QC: 2006-09-14
• Study First Posted: 2006-09-15
• Status Verified: 2007-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Last Update Submitted: 2008-03-10
• Last Update Posted: 2008-03-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	metronidazole and doxycycline	Use of placebo
1	metronidazole and doxycycline	Use of antibiotics after hospital discharge

Primary Outcome Measures

Name	Time	Method
Hospital re-admission	7 days after hospital discharge

Secondary Outcome Measures

Name	Time	Method
minimal or absent vaginal bleeding	7 days after hospital discharge
walking normally	7 days after hospital discharge
important decrease of pain	7 days after hospital discharge
no fever	7 days after hospital discharge

Trial Locations

Locations (1)

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil