Septic Abortion
Conditions
Keywords
Abortion, Infection, Antibiotics, Treatment, Pregnancy complications
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.
Interventions
DRUGmetronidazole and doxycycline
use of metronidazole 500mg/day and doxycycline 200mg/day up to 10 days
Sponsors
Hospital de Clinicas de Porto Alegre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
14 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hospital re-admission | 7 days after hospital discharge |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Brazil
Outcome results
None listed