Clindamycin Once a Day in Septic Abortion

NCT02309346 | Completed Phase 4 Results

• 1 other identifier: 14-0328
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Abortion

Keywords

clindamycin; septic abortion

Outcome Measures

Primary Outcomes (1)

• Cure (Clinical Improvement Defined as Reduce of Pain, Bleeding and no Fever for 48h)

  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 Outcomes (1)

• Hospital Readmission Within 7 Days

  7 days

Study Arms (2)

clindamycin once a day

EXPERIMENTAL

Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day until clinical improvement

Drug: Clindamycin

clindamycin thrice a day

ACTIVE COMPARATOR

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

Interventions

Clindamycin DRUG

Use of Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day

clindamycin once a day; clindamycin thrice a day

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

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

Location

Related Publications (17)

• Singh S. Hospital admissions resulting from unsafe abortion: estimates from 13 developing countries. Lancet. 2006 Nov 25;368(9550):1887-92. doi: 10.1016/S0140-6736(06)69778-X.

  PMID: 17126721 BACKGROUND

• Ahman E, Shah IH. New estimates and trends regarding unsafe abortion mortality. Int J Gynaecol Obstet. 2011 Nov;115(2):121-6. doi: 10.1016/j.ijgo.2011.05.027. Epub 2011 Aug 31.

  PMID: 21885049 BACKGROUND

• Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.

  PMID: 8022443 BACKGROUND

• Del Priore G, Jackson-Stone M, Shim EK, Garfinkel J, Eichmann MA, Frederiksen MC. A comparison of once-daily and 8-hour gentamicin dosing in the treatment of postpartum endometritis. Obstet Gynecol. 1996 Jun;87(6):994-1000. doi: 10.1016/0029-7844(96)00054-3.

  PMID: 8649712 BACKGROUND

• Hemsell DL, Martens MG, Faro S, Gall S, McGregor JA. A multicenter study comparing intravenous meropenem with clindamycin plus gentamicin for the treatment of acute gynecologic and obstetric pelvic infections in hospitalized women. Clin Infect Dis. 1997 Feb;24 Suppl 2:S222-30. doi: 10.1093/clinids/24.supplement_2.s222.

  PMID: 9126697 BACKGROUND

• French LM, Smaill FM. Antibiotic regimens for endometritis after delivery. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD001067. doi: 10.1002/14651858.CD001067.pub2.

  PMID: 15495005 BACKGROUND

• Savaris RF, de Moraes GS, Cristovam RA, Braun RD. Are antibiotics necessary after 48 hours of improvement in infected/septic abortions? A randomized controlled trial followed by a cohort study. Am J Obstet Gynecol. 2011 Apr;204(4):301.e1-5. doi: 10.1016/j.ajog.2010.11.017. Epub 2010 Dec 31.

  PMID: 21195382 BACKGROUND

• Nicolau DP, Freeman CD, Belliveau PP, Nightingale CH, Ross JW, Quintiliani R. Experience with a once-daily aminoglycoside program administered to 2,184 adult patients. Antimicrob Agents Chemother. 1995 Mar;39(3):650-5. doi: 10.1128/AAC.39.3.650.

  PMID: 7793867 BACKGROUND

• Rao SC, Srinivasjois R, Hagan R, Ahmed M. One dose per day compared to multiple doses per day of gentamicin for treatment of suspected or proven sepsis in neonates. Cochrane Database Syst Rev. 2011 Nov 9;(11):CD005091. doi: 10.1002/14651858.CD005091.pub3.

  PMID: 22071818 BACKGROUND

• Plaisance KI, Drusano GL, Forrest A, Townsend RJ, Standiford HC. Pharmacokinetic evaluation of two dosage regimens of clindamycin phosphate. Antimicrob Agents Chemother. 1989 May;33(5):618-20. doi: 10.1128/AAC.33.5.618.

  PMID: 2751277 BACKGROUND

• Livingston JC, Llata E, Rinehart E, Leidwanger C, Mabie B, Haddad B, Sibai B. Gentamicin and clindamycin therapy in postpartum endometritis: the efficacy of daily dosing versus dosing every 8 hours. Am J Obstet Gynecol. 2003 Jan;188(1):149-52. doi: 10.1067/mob.2003.88.

  PMID: 12548209 BACKGROUND

• Moberg PJ, Gottlieb C, Nord CE. Anaerobic bacteria in uterine infection following first trimester abortion. Eur J Clin Microbiol. 1982 Apr;1(2):82-6. doi: 10.1007/BF02014196.

  PMID: 6890898 BACKGROUND

• Soper DE. Postpartum endometritis. Pathophysiology and prevention. J Reprod Med. 1988 Jan;33(1 Suppl):97-100.

  PMID: 3278114 BACKGROUND

• Giugno CS, Silva AL, Fuhrich DG, Rabaioli PS, Goncalves KG, Sartor NC, Savaris RF. Daily dose of clindamycin versus standard divided doses in obstetrical and gynecological infections: a retrospective cohort study. Int J STD AIDS. 2013 Nov;24(11):893-8. doi: 10.1177/0956462413487516. Epub 2013 Jul 19.

  PMID: 23970615 BACKGROUND

• Grimes DA. The "CONSORT" guidelines for randomized controlled trials in Obstetrics & Gynecology. Obstet Gynecol. 2002 Oct;100(4):631-2. doi: 10.1016/s0029-7844(02)02233-0. No abstract available.

  PMID: 12383524 BACKGROUND

• Blackwelder WC. "Proving the null hypothesis" in clinical trials. Control Clin Trials. 1982 Dec;3(4):345-53. doi: 10.1016/0197-2456(82)90024-1.

  PMID: 7160191 BACKGROUND

• Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ. 1999 Sep 11;319(7211):670-4. doi: 10.1136/bmj.319.7211.670.

  PMID: 10480822 BACKGROUND

MeSH Terms

Conditions

Abortion, Septic

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Pregnancy Complications, Infectious; Infections; Abortion, Spontaneous; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Results Point of Contact

• Title: Ricardo Francalacci Savaris
• Organization: Hospital de Clínicas de Porto Alegre

rsavaris@hcpa.edu.br

+55 51 33596042

Study Officials

• Ricardo F Savaris, MD, PhD

  Federal University of Rio Grande do Sul

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: randomization in blocks of 4

Study Record Dates

• First Submitted: December 3, 2014
• First Posted: December 5, 2014
• Study Start: December 17, 2014
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 1, 2026
• Results First Posted: December 5, 2025

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: undefined
• Access Criteria: public after completion, no access by now

Locations

BR (1)