Periodontal Infection and Prematurity Study - Tabular View

Tracking Information

First Received Date ^ICMJE

June 30, 2005

Last Updated Date

November 30, 2007

Start Date ^ICMJE

October 2004

Primary Completion Date

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

Same as current

Change History

Complete list of historical versions of study NCT00116974 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment

Condition ^ICMJE

Periodontal Diseases
Premature Birth

Intervention ^ICMJE

Procedure: Scaling and root planing

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

2100

Estimated Completion Date

May 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Gestational age between 6 and 20 completed weeks

Exclusion Criteria:

Periodontal treatment during the pregnancy
Antibiotic use within 2 weeks of enrollment
Use of antimicrobial mouthwash within 2 weeks
Multiple gestation
Known mitral valve prolapse

Gender

Female

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00116974

Responsible Party

George A. Macones, M.D., Chair, Department of Obstetrics and Gynecology, Washington University in St. Louis

Study ID Numbers ^ICMJE

801404

Study Sponsor ^ICMJE

University of Pennsylvania

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

George A Macones, M.D.

University of Pennsylvania

Information Provided By

University of Pennsylvania

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP