Prolonged Treatment for Infected Abortion After Hospital Discharge. (APA)

Hospital de Clinicas de Porto Alegre

Status and phase: Terminated; Phase 4

Conditions: Septic Abortion

Treatments: Drug: metronidazole and doxycycline

Study type: Interventional

Funder types: Other

Identifiers

NCT00376493

APA 05-452

Details and patient eligibility

About

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.

Full 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.

Enrollment: 56 patients

Sex: Female

Ages: 14 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Use of antibiotics after hospital discharge

Treatment:

Drug: metronidazole and doxycycline

2

Placebo Comparator group

Description:

Use of placebo

Treatment:

Drug: metronidazole and doxycycline