Obstetrics and Periodontal Therapy (opt) Study Manual of Operations Version 1 March 3, 2003 Brief Table of Contents



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Obstetrics and Periodontal Therapy Study





















































































































































































































































































































































































































































OPT Form 33 V1 March 03

Column 1: PID/Visit

Column 2: C-reactive protein (CRP; ng/ml)

Columns 3-7: IL-1b, IL-6, IL-8, PGE2, TNFa (all pg/0.1ml)

Column 8: MMP-9 (concentration range not known at present)

Columns 9-15: IgG antibody to each of the 7 bacterial species assayed in the plaque samples (ng-ug/ml)

Column 16: Endotoxin (endotoxin units)


To be E-mailed to the DCC (e-mail to helen@ccbr.umn.edu) as attached Excel files.



III.6. Informed Consent (Including Consent Forms)
III.6.1. Informed consent
A subject who is randomized into the study will be consented twice:
• a brief consent, at the Recruitment Visit, before the pre-screening exam (see Section II.1.1). The exception to this is at the Kentucky site.

the main study consent, also at the Recruitment Visit, after the pre-screening exam, during the process of enrollment (see Section II.2).


For both of these consents, the Study Coordinator or other trained staff member performs the formal process of obtaining consent. Failure to obtain informed consent and a signed consent form from each subject before the pre-screening exam (for the brief pre-screening consent) and before enrollment (for the main study consent) is a serious protocol violation.
Both consent forms are given below for each of the Enrollment Sites, in Sections III.6.2 through III.6.5.
The remainder of this section applies to either the brief pre-screening consent or the main study consent.
Before a potential subject is given the form, the Study Coordinator must discuss the nature of the study, randomization, blinding, study procedures, the importance of compliance to study procedures, potential risks and benefits, and the duration of the study. The potential subject must be told that she is not obligated to participate, that there will be no penalty for declining to participate, and that treatment will not be compromised if patients do not participate or cease participation at any time.
Potential subjects must then be given ample time to read and understand the form and to ask questions. If the potential subject cannot read for any reason, clinic staff must read the consent form aloud to her. Clinic staff should use appropriate sensitivity when administering the consent form, for example, they should not ask the subject if she can read, but rather should ask whether she would prefer to have the consent form read to her or to read it herself. Clinic staff may choose to provide an audio-tape of the consent form to potential subjects who cannot read. The audio tape should record a clear-voiced person reading the consent form at a reasonable speed. If the potential subject cannot understand English, then the consent process must be administered in the subject's language or translated by an interpreter, in the presence of the Study Coordinator.
After the subject signs the consent form, a signed copy is given to the patient for her records. A second copy is kept by Study Coordinator in a locked cabinet with other confidential patient information.
III.6.2. Consent forms for New York Enrollment Site


HARLEM HOSPITAL CENTER-COLUMBIA UNIVERSITY

DEPARTMENT OF OBSTETRICS & GYNECOLOGY

AND

DEPARTMENT OF DENTISTRY
PATIENT INFORMED CONSENT
EFFECTS OF PERIODONTAL THERAPY ON PRETERM BIRTH

IRB# 01-12-035
Principal Investigator: Stephen Matseone, M.D.

Department Director, Department of Obstetrics and Gynecology

Harlem Hospital Center
Co-Investigators: Panos N. Papapanou, D.D.S., Ph.D.

Director, Division of Periodontics

Columbia University School of Dental & Oral Surgery
Dennis A. Mitchell, D.D.S., M.P.H.

Assistant Professor of Clinical Dentistry

Division of Periodontics

Columbia University School of Dental & Oral Surgery

Department of Dentistry

Harlem Hospital Center


Stephen P. Engebretson, D.M.D., M.S.

Assistant Professor of Dentistry

Division of Periodontics

Columbia University School of Dental & Oral Surgery

Bruce Pihlstrom, DDS

Professor and Director

Oral Health Clinical Research Center

University of Minnesota School of Dentistry



Sponsor: National Institute of Dental and Craniofacial Research

Introduction:
Because you are pregnant and because you also have periodontal disease (gum disease or pyorrhea), you are being invited to participate in a research study that will help determine if treating gum disease will decrease the risk of having a premature baby. Periodontal disease is an infection caused by bacterial plaque (germs) that very slowly and painlessly destroys the bone around your teeth. We want to find out if treating your gum disease will decrease the chance of having a premature baby.

Purpose of the Study:
There are many known risk factors for having a premature baby. These include diabetes, hypertension, smoking, age, genital tract infection, previous low birth weight baby, drug abuse and socioeconomic status. There are also some unknown risk factors. Recently, some scientists have suggested that periodontal disease may be one of the factors that cause pre-term low birth weight babies. The purpose of the study is to determine if periodontal treatment will help to prevent women from having premature babies. The investigators will also study whether the treatment will control gum disease and decrease bacteria or germs that cause gum disease. No drugs or other medical devices will be used in this study. Approximately 206 women will participate in this phase of the study at each site.

Study Procedures: What will happen if you are in the study
If you choose to be in the study, you will be scheduled to see a dentist at the Harlem Hospital Dental Clinic during your second trimester. Your teeth will be checked for cavities, plaque and tartar. A small amount of blood, about 2 tablespoons, will be drawn. Also, a dental probe with a dull tip will be moved around your teeth to measure the space between your gums and teeth and to see if your gums bleed when they are gently touched. A small sample of the plaque around your teeth will be scraped off. You will also be asked some questions about your medical history and pregnancy.
After your exam, you will be assigned to one of two study groups. The assignment is totally by chance, similar to the flip of a coin. The study workers have no way of knowing which group you will be placed in. You may not choose your group.


If you are in Group One:


Starting in the second trimester, you will have your teeth cleaned and will receive personal instructions maintaining good oral health. Each month, you will have your teeth polished and oral hygiene instructions will be reviewed. Every other month, a brief dental exam will be done to check on the state of your periodontal disease. A small sample of plaque will be collected at that time. Any cavities or other dental problems will be treated. This will continue each month until your baby is born. Around 24-28 weeks, about 2 tablespoons of blood will be drawn. After your baby is born, a nurse will record information about your health and medical background from your medical record. Following the study, you will be referred to your dentist if additional dental work is needed, but the study will not pay for any of this additional dental work.
If you are in the Group Two:

Starting in the second trimester, you will have a dental examination and plaque sample collection each month. Any cavities or other dental problems will be treated. If signs of periodontal disease begin to worsen, you will be removed from the study and you will receive treatment. At around 24-28 weeks, about 2 tablespoons of blood will be drawn. After the baby is born, a nurse will record information about your health and medical background from your medical record. Then you will received a complete cleaning and periodontal treatment and will be referred to your dentist if additional dental work is needed.


For Both Groups:

We will record information from your medical records about drug and alcohol use and addiction, as well as tobacco use. We will also record information about your baby's health and weight. All information that we record will be kept strictly confidential. We will not record your name on any information that we collect from your records and access to data collected in the study will only be available to study personnel. You will be asked to sign a separate form that gives permission for the study doctors to look at and record your delivery in formation and also your baby's medical records.



Voluntary Participation:
You will be examined to see if you can be in the study. No one will try to make you be in the study. It is your choice. If you choose to be in the study, you can stop at any time for any reason. You will not be treated differently if you decide not to be in the study or stop being in the study after you start. The Harlem Hospital does not discriminate against any individual based on race, ethnic origin, religion, gender, age or socioeconomic status. You will be asked to stay in the study until your baby is born.


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