Clindamycin Once a Day in Septic Abortion (CLINDA-PRO)

March 16, 2026 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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 three daily doses.

OBJECTIVES The objective of this study is to verify the equivalence of using Clindamycin once a day versus 3 times daily in the rates of cure of septic abortion.

Hypotheses H0: Ps> Pn+2 The percentage of clinical cure with standard treatment (Ps) is greater than the rate of cure of alternative treatment + 2%.

Ha: Ps - 2% ≤ Pn The percentage of clinical cure with traditional treatment (Ps) minus 2% is less than or equal to the percentage of cure alternative treatment (Pn).

Variables

  1. Standard treatment (Clindamycin 3x daily)
  2. Alternative treatment (1x daily Clindamycin)
  3. Clinical improvement (present or absent), defined as absence of fever (≤37.7 ° C), eating and walking without difficulty, as already described in the literature.

Materials and methods Design Randomized, prospective, double-blind study with two arms that follow the parameters of the CONSORT (17).

Geographic and temporal limitations The study will be conducted in patients attending the emergency unit at HCPA. A period of 24 months for data collection (about 4 patients per month), it will be necessary to reach sample size.

Inclusion criteria

All patients who come to emergency unit at HCPA with clinical diagnosis of septic abortion and will be treated with Clindamycin will be invited. The diagnosis of infected abortion is the same as used previously described by our group (9). Briefly, the presence of one of the criteria below in a < 20 weeks gestation, associated with a suspected ovular infection:

  1. History of intrauterine manipulation with contaminated objects.
  2. Vaginal discharge with foul odor.
  3. Presence of pus flowing through the cervix.
  4. Signs of peritoneal irritation.
  5. leukocytosis (≥ 14,000 leukocytes / ml).
  6. Warm Extremities, thready pulse and tachycardia (HR> 110 bpm)
  7. Cyanosis and / or paleness
  8. Tachypnea (MR> 30mrpm)
  9. hypotension (Systolic Blood Pressure <90 mmHg)
  10. Oliguria
  11. Hyperthermia (≥ 37.8 ° C)

Exclusion criteria

Will be excluded all patients who:

  1. Do not wish to participate in the project.
  2. They used antibiotics prior to hospitalization (1 week period).
  3. Being allergic to clindamycin or gentamicin.

Execution Patients eligible for the study will be invited to participate in the study at hospital admission for uterine curettage. After reading and signing the informed consent, patients will answer a standardized interview and after the interview, she will be randomized.

Randomization Subjects will be randomly allocated to treatment with clindamycin 3 times a day, or once a day; random sequence will be generated by a computer grouped into blocks of 4 treatments. The randomization sequence will be obtained from sequential sealed opaque envelope that will be in possession of the pharmacy emergency service HCPA. Researcher will not have access to the following treatment sequence. The Pharmacy Service will prepare the medication that will be part of routine emergency Gynecological Unit.

Patients and researchers will be blind to treatment allocation; saline infusion will be given in the place of clindamycin to keep patients blind to treatment arm.

Treatment

The regimen will consist of:

Standard treatment (Ps.): Clindamycin (900mg intravenously 8/8 hours diluted in 250 ml saline 0.9% solution (SF). The first vial of SF will contain 240 mg of gentamicin.

Alternative treatment (Pn): Clindamycin (2700mg) + gentamicin (240 mg) diluted in 250 ml of 0.9% saline. Two additional vials of SF 0.9% will be infused every 8 h as placebo.

The treatment will be continued up to 48 hours of good clinical condition, defined as absence of fever, decreased vaginal bleeding, minimal or no pain (AVS <4), eating, evacuating and walking normally.

Follow-up All women included in the study will be reviewed within 7 days after discharge as routine at the gynecologic emergency unit, to receive the results of the pathology.

Outcomes

The following outcomes will be assessed:

  1. Clinical improvement until discharge in number of days of hospitalization, complications related to treatment.
  2. 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.
  3. Hospital readmission within 7 days after discharge due to fever (Tax ≥37.8ºC), persistent pelvic pain, persistence or increase of uterine bleeding, or other hospital admission related to the septic abortion.
  4. Presence of urinary tract infection or candidiasis will not be considered as treatment failure.

Sample Size The sample size was calculated as a trial of non-inferiority, using the formula proposed in the literature (18). According to data obtained in a retrospective study by our group (16) we expect that the estimated rate of clinical cure is 99% (95% CI - 95 to 99%) in the group with three daily doses and 100% (95% CI - 99 to 100%) in the experimental treatment. For a non-inferiority study, using a power of 90%, an alpha error of 5% and a lower limit for non-inferiority of 2%, 95 cases will be needed in each group.

Statistical analysis Data will be analyzed by intention to treat and per protocol. The definition of intention to treat is based on the criteria suggested in the literature. The statistical analysis will be performed using Student t-test to compare the difference of means; chi-square test will be used to compare proportions with confidence intervals.

Study Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: clindamycin once a day
Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day until clinical improvement
Drug: Clindamycin
Use of Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day
Active Comparator: clindamycin thrice a day
Clindamycin 900mg i.v. 8/8 h diluted in 250ml of sterile saline solution. In one of the solutions, 240 mg of gentamicin was diluted once a day.
Drug: Clindamycin
Use of Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cure (Clinical Improvement Defined as Reduce of Pain, Bleeding and no Fever for 48h)
Time Frame: cure at 72 hours

Clinical improvement was defined by meeting all of the following criteria for a minimum of 48 consecutive hours: Reduction in pain, Reduction in vaginal bleeding, Absence of fever (afebrile)" Treatment failure was defined as the occurrence of any of the following events during hospital admission: Persistence of fever (temperature ≥37.8ºC), Worsening of abdominal pain, Persistent vaginal bleeding, Necessity to change the primary antibiotic (clindamycin), Addition of any other intravenous or oral antibiotics.

For the purposes of analysis, patients who were lost to follow-up were classified as treatment failures.
cure at 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital Readmission Within 7 Days
Time Frame: 7 days
Number of patients who required hospital readmission for a repeat uterine curettage within 7 days of initial hospital discharge. Data was collected from patient's electronic medical records.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: Ricardo F Savaris, MD, PhD, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2014

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

December 31, 2023

Study Registration Dates

First Submitted

December 3, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimated)

December 5, 2014

Study Record Updates

Last Update Posted (Actual)

April 1, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-0328

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

We plan to share anonymized raw clinical data after completion of the study, through a URL

IPD Sharing Time Frame

undefined

IPD Sharing Access Criteria

public after completion, no access by now

IPD Sharing Supporting Information Type

  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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