Clinical Trial: Clindamycin Once a Day in Septic Abortion

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: A Randomized Clinical Trial Between Clindamycin Once and Thrice a Day in Septic Abortion.

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 rates of cure between once or thrice a day use of clindamycin with gentamicin in cases of septic abortion.


Detailed Summary:

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 hospitalized due to complications from induced abortions, which equates to a rate of 5-7 per thousand women.

Abortion remains a leading cause of maternal death in developing countries. According to the World Health Organization, it is estimated that 1 in 8 maternal deaths occur from complications of illegal abortion. Septic abortions play an important role in the maternal morbidity and mortality. The diagnosis of septic abortion should be considered when a woman of reproductive age presents with menstrual delay, vaginal bleeding accompanied by abdominal pain and fever.

In 1989, Plaisance et al. demonstrated that Clindamycin, an antibiotic used for septic abortion, could be prescribed at a dose of 12/12 hours, and bacterial inhibitory serum levels were similar to those in divided doses 6/6 hours. In 2003, Livingston et al. published the results of gentamicin and clindamycin combined in a single daily dose for cases of post-cesarean endometritis. Administration of clindamycin differed by being in a dose of 2700mg daily dose of different fractional 6/6 hours, or 8/8 hours, and the cure rates were 82% (45 of 56 cases successes) in a single daily dose (13). The etiology of postpartum endometritis is similar to that in infected abortion (14, 15), but little information exists regarding the use of single daily dose in this disease.

A retrospective study recently conducted by our group showed that patients with infected abortion treated with Clindamycin single dose achieved cure rates of 98% (95% CI - 95 to 99%), suggesting an equivalence between a single daily dose and treatment conventional
Sponsor: Hospital de Clinicas de Porto Alegre

Current Primary Outcome: Cure (Clinical improvement defined as reduce of pain, bleeding and no fever for 48h) [ Time Frame: 72 hours ]

Clinical improvement defined as reduce of pain, bleeding and no fever for 48h Treatment failure will be considered as persistence of fever (≥37.8ºC) during hospital admission, worsening of abdominal pain, persistent vaginal bleeding, need for exchange clindamycin due to treatment failure, or the need to add other antibiotics, either intravenously or orally.


Original Primary Outcome: Cure (Clinical improvement defined as reduce of pain, bleeding and no fever for 48h) [ Time Frame: 72 hours ]

Clinical improvement defined as reduce of pain, bleeding and no fever for 48h


Current Secondary Outcome: Complications (Return to the hospital for admission related to the evacuation procedure within 7 days) [ Time Frame: 7 days ]

Return to the hospital for admission related to the evacuation procedure within 7 days


Original Secondary Outcome: Same as current

Information By: Hospital de Clinicas de Porto Alegre

Dates:
Date Received: December 3, 2014
Date Started: December 2014
Date Completion: December 2017
Last Updated: June 29, 2016
Last Verified: June 2016