Status:

COMPLETED

Clindamycin Once a Day in Septic Abortion

Lead Sponsor:

Hospital de Clinicas de Porto Alegre

Conditions:

Septic Abortion

Eligibility:

FEMALE

18-50 years

Phase:

PHASE4

Brief Summary

Septic abortion is a serious condition. Women with septic abortion are treated with clindamycin plus gentamicin using divided doses, i.e., thrice a day. The objective of this study is to compare the ...

Detailed Description

Obstetric infections are very common, especially in developing countries, as a consequence of the practice of unsafe abortion. In these countries, an estimated five million women each year are hospita...

Eligibility Criteria

Inclusion

  • Women with clinical diagnosis of septic abortion: Briefly, a suspicion of infected/septic abortion was confirmed by the presence of at least one of the following clinical signs: a history of intrauterine manipulation with contaminated objects; foul-smelling vaginal discharge; purulent discharge from the cervix; signs of peritoneal irritation; leukocytosis (leukocyte count \> 14,000/mL); fever (temperature ≥ 37.8°C); or signs of a systemic inflammatory response, including tachycardia (heart rate \> 110 bpm), tachypnoea (respiratory rate \> 30 breaths/min), arterial hypotension (systolic blood pressure \< 90 mmHg), oliguria, cyanosis, or pallor.

Exclusion

  • Refuse to participate in the study
  • Use of antibiotics with 1 week prior randomization
  • Known allergy to clindamycin or gentamycin

Key Trial Info

Start Date :

December 17 2014

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2023

Estimated Enrollment :

202 Patients enrolled

Trial Details

Trial ID

NCT02309346

Start Date

December 17 2014

End Date

December 31 2023

Last Update

December 5 2025

Active Locations (1)

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1

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil, 90035-003