Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy
This study is currently recruiting participants.
Verified March 2012 by Università degli Studi di Brescia
Sponsor:
Università degli Studi di Brescia
Collaborator:
Azienda Ospedaliera Spedali Civili di Brescia
Information provided by (Responsible Party):
Federico Prefumo, Università degli Studi di Brescia
ClinicalTrials.gov Identifier:
NCT01558388
First received: March 15, 2012
Last updated: March 16, 2012
Last verified: March 2012
| Tracking Information | |||||||||
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| First Received Date ICMJE | March 15, 2012 | ||||||||
| Last Updated Date | March 16, 2012 | ||||||||
| Start Date ICMJE | September 2009 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01558388 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Preterm delivery <37 weeks [ Time Frame: within 43 weeks of gestation ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy | ||||||||
| Official Title ICMJE | Randomised Control Trial of Probiotics Versus Placebo as Adjuvant to Oral Clindamycin Treatment for Bacterial Vaginosis During Pregnancy | ||||||||
| Brief Summary | Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial vaginosis has been reported in 10-70% of cases. This study aims to verify if administration of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of bacterial vaginosis during pregnancy. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Bacterial Vaginosis | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||
| Estimated Completion Date | December 2012 | ||||||||
| Estimated Primary Completion Date | December 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 18 Years to 45 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Not Provided | ||||||||
| Location Countries ICMJE | Italy | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01558388 | ||||||||
| Other Study ID Numbers ICMJE | Spedali Civili 926 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Federico Prefumo, Università degli Studi di Brescia | ||||||||
| Study Sponsor ICMJE | Università degli Studi di Brescia | ||||||||
| Collaborators ICMJE | Azienda Ospedaliera Spedali Civili di Brescia | ||||||||
| Investigators ICMJE |
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| Information Provided By | Università degli Studi di Brescia | ||||||||
| Verification Date | March 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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