Periodontal Infection and Prematurity Study
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2007 by University of Pennsylvania.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
University of Pennsylvania
Information provided by:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00116974
First received: June 30, 2005
Last updated: November 30, 2007
Last verified: November 2007
| Tracking Information | |||||
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| First Received Date ICMJE | June 30, 2005 | ||||
| Last Updated Date | November 30, 2007 | ||||
| Start Date ICMJE | October 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
Whether screening and treating periodontal disease using scaling and root planing early in pregnancy can reduce the incidence of spontaneous preterm birth <35 weeks [ Time Frame: 9 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00116974 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Periodontal Infection and Prematurity Study | ||||
| Official Title ICMJE | Periodontal Infection and Prematurity Study | ||||
| Brief Summary | This research project is a multi-center double-blind, parallel, randomized, controlled clinical trial design comparing the efficacy of dental scaling and root planing to control treatment (superficial cleaning) for the prevention of preterm birth in pregnant women with periodontal disease. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 3 | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Scaling and root planing
Scaling and root planing |
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| Study Arm (s) |
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| Publications * | Jeffcoat M, Parry S, Sammel M, Clothier B, Catlin A, Macones G. Periodontal infection and preterm birth: successful periodontal therapy reduces the risk of preterm birth. BJOG. 2011 Jan;118(2):250-6. Epub 2010 Sep 14. | ||||
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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 | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 2100 | ||||
| Estimated Completion Date | May 2008 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00116974 | ||||
| Other Study ID Numbers ICMJE | 801404 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | George A. Macones, M.D., Chair, Department of Obstetrics and Gynecology, Washington University in St. Louis | ||||
| Study Sponsor ICMJE | University of Pennsylvania | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pennsylvania | ||||
| Verification Date | November 2007 | ||||
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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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