Phase 4
N=202
Clindamycin Once a Day in Septic Abortion
Septic Abortion
Bottom Line
View on ClinicalTrials.gov: NCT02309346 ↗Enrolled (actual)
202
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Cure (Clinical Improvement Defined as Reduce of Pain, Bleeding and no Fever for 48h) — 94.06; 86.14 percentage of cure — p=0.06
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Clindamycin (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Hospital de Clinicas de Porto Alegre
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cure (Clinical Improvement Defined as Reduce of Pain, Bleeding and no Fever for 48h) |
94.06; 86.14 | 0.06 |
| SECONDARY Hospital Readmission Within 7 Days |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Refuse to participate in the study
- Use of antibiotics with 1 week prior randomization
- Known allergy to clindamycin or gentamycin
Data sourced from ClinicalTrials.gov (NCT02309346). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.