Study Results
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
202 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-12-17
Study Completion Date
2023-12-31
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Septic Abortion
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
randomization in blocks of 4
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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clindamycin once a day
Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day until clinical improvement
Group Type
EXPERIMENTAL
Clindamycin
Intervention Type
DRUG
Use of Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day
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.
Group Type
ACTIVE_COMPARATOR
Clindamycin
Intervention Type
DRUG
Use of Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day
Interventions
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Clindamycin
Use of Clindamycin 2700mg+gentamycin 240mg+ 250ml sterile saline solution i.v. once a day
Intervention Type
DRUG
Eligibility Criteria
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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
* Use of antibiotics with 1 week prior randomization
* Known allergy to clindamycin or gentamycin
Minimum Eligible Age
18 Years
Maximum Eligible Age
50 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Hospital de Clinicas de Porto Alegre
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ricardo F Savaris, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Federal University of Rio Grande do Sul
Locations
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Site Status
Countries
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Brazil
References
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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.
Reference Type
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.
Reference Type
BACKGROUND
Stubblefield PG, Grimes DA. Septic abortion. N Engl J Med. 1994 Aug 4;331(5):310-4. doi: 10.1056/NEJM199408043310507.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Soper DE. Postpartum endometritis. Pathophysiology and prevention. J Reprod Med. 1988 Jan;33(1 Suppl):97-100.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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14-0328
Identifier Type: -
Identifier Source: org_study_id
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