MOP-IndexVersion07-08-03

MOP-IndexVersion07-08-03 - Obstetrics and Periodontal...

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Unformatted text preview: Obstetrics and Periodontal Therapy (OPT) Study Manual of Operations Version 1 March 3, 2003 Version 1 3/3/03 Version 1 3/3/03 Brief Table of Contents I. Overview I.1. Introduction and Overview of the Study. ...................................................................... I-1 I.2. Organization and Administration (Including Study Roster). ...................................... I-27 I.3. Schedule of Visits and Evaluations. ............................................................................ I-43 II. A Subject's Path Through the Study II.1. Recruitment, Consent, and Entry into the Study. ....................................................... II-2 II.2. The Baseline/Randomization Visit (Visit 1). ........................................................... II-14 II.3. Essential Dental Care. .............................................................................................. II-30 II.4. Study Intervention: Immediate Periodontal Therapy (Test Group). ....................... II-33 II.5. Maintenance Visits (Visits 2 to 6). ........................................................................... II-36 II.6. After The Birth (Form 60, Delivery Data & Pregnancy Adverse Events). .............. II-44 II.7. Deferred Periodontal Therapy (Control Group). ...................................................... II-49 II.8. Subjects Who Withdraw Consent or Are Lost to Follow-up. .................................. II-51 III. Details on Procedures III.1. Periodontal Measurements. ..................................................................................... III-2 III.2. Collecting and Storing Dental Plaque Samples (Enrollment Site Procedures). ............................................................................................................. III-8 III.3. Overview of Plaque Assays (Microbiology Lab Procedures). .............................. III-17 III.4. Collecting, Processing, and Storing Serum Samples (Enrollment Site Procedures). ........................................................................................................... III-25 III.5. Overview of Serum Assays (Host Response Lab Procedures). ............................. III-33 III.6. Informed Consent (Including Consent Forms). ..................................................... III-39 III.7. Maintaining Confidentiality. .................................................................................. III-77 III.8. Blinding and Unblinding. ...................................................................................... III-80 III.9. Reporting Adverse Events. .................................................................................... III-82 III.10. Data and Safety Monitoring Activities. ............................................................... ....
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MOP-IndexVersion07-08-03 - Obstetrics and Periodontal...

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