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CHAPTER 3 RECRUITMENT AND ENROLLMENT 3.1. Initial Contact, Recruitment, Pre-Screening Participants will be recruited in the obstetrics clinics of the Enrollment Sites during a pre-natal visit. All women at least 16 years of age and thought to be less than 236 weeks gestation will be considered possibly eligible for the study. To meet recruitment goals, fifteen subjects must be enrolled and randomized at each site per month. Each site’s recruitment efforts should be planned to meet this enrollment goal. Timing of enrollment is critical. Participants who meet eligibility criteria and are enrolled must have completed all baseline data collection, randomization, and periodontal treatment (if randomly selected for pre-natal treatment) by 236 weeks gestation. The screening and recruitment process includes the following steps: A potential participant makes a pre-natal visit to the clinic and is identified by study personnel. A review of medical history is obtained according to the site’s standard procedure and clinic practice and reviewed to pre-screen potentially eligible participants. Potentially eligible participants are approached by study personnel and offered an opportunity for screening, enrollment, and participation in the study. Informed consent for study screening is obtained. Some sites may also choose to consent for study participation at this time. Screening ultrasound is required to determine gestational age (if not already done as part of previous pre-natal visit). Periodontal screening examination for eligibility. 3.1.1. Recruitment Staff Each center’s Study Coordinator who attended the protocol and data collection training session prior to the start of the study may train additional staff needed for recruitment and pre-screening procedures. The Study Coordinator’s full responsibilities are outlined in Chapter 2.8.2. Recruitment responsibilities include: Establishing a method to ensure that all potential participants are evaluated for study eligibility. Obtaining and reviewing the medical records of the potential participant’s current health and pregnancy as well as previous pregnancy records, if available, to determine eligibility. CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 1 Training and certifying additional staff recruitment for medical records review and for completing pre-screening procedures and data collection forms. Obtaining signed consents from participants for screening and study procedures, per each clinical center’s IRB requirements. Developing a procedure at their clinical center that: 1. Tracks potential participants through the OB and periodontal screening procedures. 2. Identifies eligible participants after screening. 3. Consents and enrolls study participants. 4. Schedules participants for baseline procedures. 3.1.2. Participant Screening Log (PSL) All patients who are at least 16 years of age, and who are thought to be <23 weeks gestation (based on best available information at the time) should be considered potential participants, and entered onto the Participant Screening Log form (PSL). Each PSL form documents the screening results of 10 potential participants. The form is identified with the Clinical Site’s ID number. Site ID numbers are as follows: San Antonio – MOT00000 Alabama MOA00000 Duke MOD00000 Participant Screening Log Site ID: __ __ __ __ __ __ __ __ Form: PSL Ver: A Visit #: 00 Seq #: __ __ 6 Instructions: Record eligibility status for all potential participants ≥ 16 years with suspected gestation < 23 weeks who are screened for MOTOR. Potential Participant Name or Hospital # (not data entered) 0 Screening Date 01 __ __/__ __/ 20__ __ 02 __ __/__ __/ 20__ __ 03 __ __/__ __/ 20__ __ 04 __ __/__ __/ 20__ __ 05 __ __/__ __/ 20__ __ 06 __ __/__ __/ 20__ __ 07 __ __/__ __/ 20__ __ 08 __ __/__ __/ 20__ __ 09 __ __/__ __/ 20__ __ 10 __ __/__ __/ 20__ __ Race codes 1 = Black or African-American 2 = White 3 = Asian 4 = Hawaiian or Pacific Islander 5 = Am. Indian or Alaska Native 6 = Other 7 = Unknown 8 = Refused to answer Ethnicity codes 11 = Hispanic / Latino 12 = Not Hispanic / Latino 13 = Refused to answer OB Disposition Codes 22 = Deliver elsewhere Maternal Age (Years) 6 Race code Ethnicity code 24 = Gestational age > 23 wks (screening US) 26 = Major fetal anomaly or fetal demise 27 = Placenta previa present 28 = Multi-fetal gestation 29 = Hypertension requiring meds 30 = Use of steroids 31 = Diabetes 32 = History of bladder/kidney infections 33 = Autoimmune diseases Dental Disposition Codes 41 = Undergoing periodontal treatment 42 = 5 or more teeth requiring extraction 43 = Rampant decay 44 = Does not meet perio AL requirements 46 = Use of medications causing gingival enlargement Rand? Y/N Disposition Codes OB Dental If Code=88 explain Staff Initial 47 = Periodontally hopeless tooth 48 = Overt fistula or abscess 49 = Gross visible caries, endodontic involvement, fracture 50 = Less than 20 teeth Common (OB or Dental) Disposition Codes 20 = Eligible 21 = Not interested in participating 23 = In another study 6 25 = Can’t arrange screening evaluations < 23 wks 6 34 = Eligible, but can’t arrange baseline/treatment <23 35 = Does not speak English 36 = Not enough staff 45 = Probing contraindicated (i.e. murmur req. meds) 87 = Not Screened 88 = Other The PSL captures basic demographic information on potentially eligible participants, and will provide important study recruitment information on eligible and ineligible participants. No patient identifiers are collected for entry into the study database, therefore patient confidentiality is kept in compliance with federal and IRB regulations. Pre-screening will provide a preliminary assessment of eligibility for continued screening. This is based on information obtained from the routine pre-natal clinic visit, and a review of medical records of the patient’s current health and pregnancy, as well as previous pregnancy records, if available. If a patient is deemed ineligible, the exclusion code should be recorded on the log, and no further information will be collected. If, after the medical pre-screening, the participant is still considered potentially eligible for participation, study personnel will explain the study and seek informed consent for further screening. CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 2 Once each participant has completed screening and/or their eligibility status has been determined, the PSL should be completed. Refer to the PSL QxQ’s for specific details on how to complete the data collection form. The PSL is to be data entered into the MOTOR DMS once 10 patients have completed pre-screening and/or screening. 3.2. Informed Consent All potential participants will receive informed consent material as approved by the Institutional Review Board at each center. Trained study personnel will perform the formal process of obtaining consent for screening and enrollment into the study. Sites may choose to obtain consent separately for screening and enrollment in 2 stages, or to consent patients at one time for both phases. Failure to obtain informed consent and a signed consent form from each participant before screening procedures and enrollment is a serious protocol violation. Before a potential participant is given the full consent form, the study personnel 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 participant must be told that she is not obligated to participate, that there will be no penalty for declining to participate, and that regular medical treatment will not be compromised if she does not participate or ceases participation at any time. The potential participants must then be given ample time to read and understand the form and to ask questions. If the potential participant 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 participant 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 participants who cannot read. The audiotape should record a clear-voiced person reading the consent form at a reasonable speed. If the potential participant doesn’t understand English, then the consent process must be administered in the participant’s language or translated by an interpreter, in the presence of the Study Coordinator. After the participant signs the consent form, she is given a signed copy for her records. A second signed copy is kept by the Study Coordinator in a locked cabinet with other confidential participant information, and a copy is placed in the medical records at each site. Each site is required to devise a strategy that documents and communicates refusal of specimen collection to the appropriate prenatal and post-partum data collectors. Specimens should not be collected on any participant who refuses specimen collection. CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 3 3.2.1 Specimen Consent Tracking Form (SCT) The SCT form is to be completed during the consenting process, and entered after eligibility is established. The DSCC will monitor specimen collection and consenting to assure that specimens are not shipped to the MOTOR laboratory, or if shipped, are destroyed at the laboratory. 3.3. Screening Final determination of eligibility is based on patient interview to complete medical or obstetrics inclusion/exclusion criteria not available through medical records, ultrasound results to verify gestational age, and a screening periodontal examination to assess periodontal inclusion/exclusion criteria. Each of these procedures is defined below. Screening procedures occur after screening consent has been obtained (except for ultrasound screening where previous ultrasound results are available). There is no particular order required for eligibility criteria assessment. Ordering of screening procedures should occur however it is most efficient during the patient visit, and for the patient. Data collection at screening is identified as Visit 01. Potential participants are not enrolled into the study, or assigned a study ID number until the screening process is completed. During the screening process, inclusion/exclusion criteria are documented on either the Obstetric/Medical Eligibility Form (OEF) or the Dental Eligibility Form (DEF), as appropriate (see below). When any potential participant is found to be ineligible, the Participant Screening Log is to be completed with the appropriate exclusion code, completing the screening history for this patient. 3.3.1. OB/Medical Screening Obstetrics and medical screening for eligibility is done by staff members at each clinical site who have been trained on the study protocol, MOP, and data collection forms. Screening for eligibility is based on the following criteria: Exclusion: Use of systemic steroids (including asthmatics on oral steroids, including inhalants). See section. 3.3.1.2 CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 4 Chronic hypertension or vascular disease requiring therapy Diabetes (gestational diabetes acceptable). See section. 3.3.1.2 Autoimmune disease (e.g. Lupus, HIV, AIDS) History of frequent bladder/kidney infections > 3 per year Multiple gestation Major fetal anomaly or intrauterine fetal demise present on ultrasound Prolapsed or ruptured membranes noted on speculum examination Oligohydramnios Complete placenta previa present Any obstetric finding that precludes enrollment in the dental component of the study Participating in any randomized trial with interventions or primary endpoints in conflict with MOTOR Inclusion: At least 16 years old at enrollment Pregnant and able to complete periodontal treatment prior to 23 6 weeks gestation Planning on pre-natal care and delivery at the enrollment clinical center Willing to provide informed consent, be randomized, and complete treatment protocols Eligibility criteria is documented on the Obstetrics/Medical Eligibility Form (OEF), see below. 3.3.1.2 Diabetes and Steroid Use - Exclusion Criteria There will be potential participants who have risk factors for diabetes and these patients may be screened for diabetic status at their first prenatal visit. Typically these patients will be administered the one hour glucose tolerance test (1 HR GTT) to determine if they have diabetes. If a patient fails the screening or is on the borderline of failing the 1 HR GTT she may be required to have a 3 HR GTT. If a patient fails either the 1 HR GTT and has no follow up testing or she fails the 1 HR GTT and the 3 HR GTT at her initial prenatal visit she will be considered a frank diabetic and therefore ineligible for the study. However, if the patient fails the 1 HR GTT but subsequently passes the 3 hour GTT then she will not be considered a frank diabetic patient and should be approached for enrollment. Uses of systemic steroids, including inhalants are considered exclusion criteria for the study. However, some forms of inhaled steroids are absorbed (bioavailability) topically and are not considered exclusion criteria. It will be up to each site to determine if an inhalant (either nasal or oral) is absorbed topically or systemically. There are many sources to help determine the bioavailability (absorption) of these drugs. A few examples include; http://www.druginfonet.com/, http://www.rxmed.com/, http://www.drugs.com, and http://www.rxcanadapharmacy.com and the Physician’s Desk Reference (PDR). There will be patients who are prescribed systemically absorbed steroids for an acute condition and who will only take them for a short period of time. Eligibility for these participants should be determined using the following rules. Any patient who is CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 5 prescribed systemic steroids for an acute condition must have completed or will complete the steroid treatment at least two weeks prior to randomization. At this point she is eligible for enrollment. If however, a patient is chronically taking systemic steroids she should be excluded from the study. 3.3.2. Ultrasound Examination A standard ultrasound examination (vaginal or abdominal) is required of all potential participants prior to full enrollment in the study. This serves to confirm gestational age, a singleton pregnancy, and to rule out any significant anomalies. If a participant has already had a standard ultrasound during a prior pre-natal clinic visit during this pregnancy, an additional one is not necessary if the ultrasound is able to conclusively confirm the inclusion/exclusion criteria. The date and results of the qualifying ultrasound are to be recorded onto the Obstetrics/Medical Eligibility Form (OEF), described below. 3.3.3. Obstetrics/Medical Eligibility Form (OEF) The OEF form documents the obstetric and medical inclusion and exclusion criteria of each potential participant during the screening process. Refer to the OEF QxQ’s for detailed definitions and instructions on how to complete this form. If a potential participant is deemed ineligible for MOTOR based on this screening, the examiner should explain to the participant that she is ineligible for the study and thank her for her participation. The Screening Log (PSL) should then be updated documenting the reason for ineligibility. OEF forms begun on ineligible participants are discarded and not data entered. Obstetric Eligibility Form ID: ___ ___ ___ ___ ___ ___ ___ ___ Form: OEF Ver: A Visit #: 01 Name: _________________________ Staff ID: __ __ __ Date: __ __ / __ __ / 20__ __ Seq #: 01 Instructions: This form documents the medical/ OB eligibility criteria, based on chart review and participant interview. GESTATIONAL AGE BY ULTRASOUND 1. Date of first (dating) U/S __ __/__ __/ 20 __ __ 2. LMP date __ __/__ __/ 20 __ __ 1a. Gestational age (at first U/S) ___ ___ . ____ 1b. Gestational age today ___ ___ . ____ weeks days 3. LMP date sure? 4. Was pregnancy result of in-vitro fertilization (IVF) or ART? If YES, date of IVF or ART __ __/__ __/ 20 __ __ Y Y N N Y Y Y Y N N N N EXCLUSION CRITERIA REVIEW 9. Does the participant have any of the following conditions this pregnancy? a. Major fetal anomaly or fetal demise b. Prolapsed or ruptured membranes noted on speculum examination c. Cervical os dilation ≥ 2cm noted on speculum examination d Oligohydramnios e Complete placenta previa with bleeding f. Multi-fetal gestation present g. Cerclage present or planned h. Septate or bicornuate uterus Y Y Y Y Y Y Y Y N N N N N N N N 10. Does the participant have any of the following medical conditions? a. Chronic hypertension or vascular disease requiring therapy b. Diabetes (not including gestational) c. Autoimmune disease (e.g. Lupus, HIV, AIDS) d. Congenital heart disease e. Rheumatic heart disease f. Heart murmur, defect or damage to heart valves Y Y Y Y Y Y N N N N N N 11. Is the participant using any of the following medications? a. Chronic use of steroids (including asthmatics using steroid inhalers) b. Cortisone or other medication that suppresses immune system c. Phenytoin, cyclosporine A, or calcium channel antagonists Y Y Y N N N Y N Y Y N N INCLUSION CRITERIA REVIEW 5. Is gestational age less than 23 weeks today? 6. Is participant ≥ 16 years old? 7. Planning prenatal care and delivery in this health care system? 8. Willing to provide consent, be randomized, and complete treatment protocol? For study inclusion, Questions 5-8 must be answered Yes. Potential participants who have met the OB/Med criteria, noted in question # 12, will continue with periodontal screening if they have not already. 3.3.4. 12. Is the participant participating in any randomized trial with interventions or primary endpoints in conflict with MOTOR? For study inclusion, Questions 9-12 above must be answered No. Periodontal Screening OVERALL ASSESSMENT OF MEDICAL/OB ELIGIBILITY (must be answered Yes) 6 13. Can treatment be scheduled and completed prior to 23 weeks gestation? 14. Is participant eligible for study inclusion based on medical/OB criteria? Periodontal screening is performed at each clinical site by a trained study examiner. The periodontal screening is a brief examination to assess a participant’s eligibility based on the exclusion and inclusion criteria listed below: Exclusion: CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 6 Any medical contraindication to periodontal probing or periodontal treatment that would require antibiotic prophylaxis, (e.g., congenital heart disease, use of Phen-fen for weight loss without a clear echocardiogram, mitral valve prolapse, rheumatic fever). Chronic use of medications that cause gingival enlargement such as phenytoin, cyclosporin -A, or calcium channel antagonists. Concomitant use of orthodontic appliances (braces). Hopeless periodontally involved teeth that cannot be extracted during the periodontal scaling and root planing treatment visit(s). Presence of overt fistula or abscess. Any tooth with one or more of the following: o o o o visible gross carious lesion(s) suspected endodontic involvement suspected fracture suspected root fragment And is either symptomatic by current history (2 months) or symptomatic during an occlusal loading test using a cotton roll. Inclusion: Minimum of 20 teeth present, including 3rd molars and crowns (excluding dentures and implants. Three (3) or more periodontal sites with ≥ 3mm clinical attachment loss. For purposes of MOTOR, the following definitions are used for the exclusion/inclusion criteria: 1. Periodontally hopeless tooth: A tooth that exhibits both probing criteria and mobility criteria: a) Probing criteria either 1) two or more root surfaces with 10 or more mms attachment loss or 2) one or more sites with probing depths that approximate the root apex (within 2mm) or 3) one or more sites with probing depths that go beyond the root apex. b) Mobility criteria: tooth is depressible (as determined with mouth mirror handle pressure). 2. Overt fistula or abscess: The presence of a patent fistula on the attached gingiva or mucosa as evidenced by visualization. An abscess would be evidenced as an attached gingival swelling adjacent to a tooth with erythema and flocculence upon palpation with or without evidence of intrasulcular drainage upon probing or palpation. 3. Gross visible caries, suspected endodontic involvement or fracture: Any noted dental pathology that meets both of the following Visual Criteria and Symptomatic criteria: CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 7 Visual Criteria either: 1) Gross caries that is visible without the use of a dental explorer that would appear to approximate the dental pulp or 2) Any visible tooth fracture that involves the cusp or root that would approximate pulpal involvement. Symptom Criteria: If either of these two visual criteria is present the patient is asked whether the tooth has been hurting them within the last 2 weeks. If yes, patient is excluded. If the response is no, the patient is then asked to close on cotton roll selecting the affected carious, potentially endodontically involved or fractured tooth to elicit possible symptoms, asking “Please close, Does this hurt?” If yes, patient is excluded. The screening examination will determine the periodontal eligibility of each participant. Periodontal measures will include pocket depth (PD) and attachment level (AL) assessments only up to meeting the inclusion criteria. A more detailed baseline examination will be performed on those participants deemed eligible and enrolled. Results of the periodontal screening, indicating the teeth numbers and PD and AL measurements that find the participant eligible will need to be recorded onto the DEF form (see below). 3.3.5. Dental Eligibility Form (DEF) The Dental Eligibility Form documents the dental and periodontal inclusion and exclusion criteria of each potential participant during the periodontal screening examination. If a potential participant is deemed ineligible for MOTOR based on the periodontal screening, the examiner should explain to the participant that she is ineligible for the study and thank her for her participation. This information must be relayed to the clinic recruitment staff who will update the Screening Log (PSL) for this participant. DEF forms begun on ineligible participants are discarded and not data entered. Eligible based on dental screening is documented in question # 16 of the DEF. Completed DEF forms are to be given to the recruitment staff. Dental Eligibility Form ID: ___ ___ ___ ___ ___ ___ ___ ___ Form: DEF Ver: A Visit #: 01 Name: _________________________ Staff ID: __ __ __ Date: __ __ / __ __ / 20__ __ Seq #: 01 Instructions: This form documents the periodontal eligibility criteria, based on participant interview and periodontal examination. Participant eligibility for study enrollment is based on results of both the DEF and OEF forms. MEDICAL AND MEDICATION HISTORY (Participant Interview): 1. Has a dentist or doctor ever told you that you need antibiotics or any other medication before having any dental work done? Y N 2. Are you taking cortisone or any other medicine that suppresses your immune system? Y N 3. Have you ever taken phen-phen or redux for weight loss? Y N 4. Do you take phenytoin, cyclosporin-A, or calcium channel antagonists? Y N 5. Have you ever had an operation for a heart valve, or for a stent or a shunt? Y N 6. Do you have an artificial joint? Y N a. Congenital heart disease b. Rheumatic heart disease c. Heart murmur, defect, or damage to your heart valves d. HIV or AIDS e Diabetes (not including gestational) f. Immunosuppression 8. Are you currently being treated by a dentist for gum or periodontal disease? Y Y Y Y Y Y Y N N N N N N N PERIODONTAL EXCLUSIONS (Examination): 9. Braces present? rd 10. Fewer than 20 teeth (including 3 molars)? 11. Presence of overt fistula or abscess? 12. Hopeless periodontally involved tooth that cannot be extracted during periodontal treatment? Y Y Y Y N N N N 7. Has a dentist or doctor ever told you that you have the following conditions? 13. Any tooth with one or more of the following that is symptomatic or symptomatic on occlusal loading? a. visible gross carious lesions? Y N b. suspected endodontic involvement? Y N c. suspected fracture? Y N d. root fragment? Y N PERIODONTAL INCLUSION: 14. Record Data for Qualifying Sites: Site 1: Site 2: Site 3: 15. Three or more sites with AL >= 3mm? QTS __ __ __ __ __ __ __ __ __ Y PD __ __ __ __ __ __ CEJ CAL __ __ __ __ __ __ __ __ __ N OVERALL ASSESSMENT OF DENTAL ELIGIBILITY: For study eligibility questions 1-13 should be coded NO, question 14 should document the 3 qualifying sites and question 15 must be YES. 16. Is participant eligible based on dental criteria? Y N 3.4. Study Enrollment A set of completed OEF and DEF forms CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 8 document the final eligibility of a participant for enrollment into the MOTOR study. Eligibility should also be noted on the Enrollment log for these participants. Procedures for enrollment and baseline data collection scheduling are detailed below. 3.4.1. Procedures for Completing Study Enrollment Some sites may require an additional informed consent process for study participation. These procedures should be completed at this time. After a participant has consented for study enrollment, the following procedures will complete the first process of data collection for enrollment. Update the Screening Log (PSL) for this participant indicating the participant is eligible. Assign Participant ID. ID labels should be attached to both the OEF and DEF forms. OEF and DEF forms are to be data entered. 3.4.2. Participant ID The DSCC will generate all participant ID numbers. Each site will be provided with a listing of ID numbers, a corresponding Excel spreadsheet with these numbers (for use in site data management), and ID labels for use on study forms for the first 50 enrolled participants. Additional labels for any participant ID can also be generated and printed through out the MOTOR DMS (See DMS Users Guide). Participant ID’s are further described in Chapter 13, section 13.2. 3.4.3. Participant Locator Information Form (PLF) The PLF provides contact information on each enrolled participant, and identifies the participant’s regular physician and dentist, if she has them. If the participant has a regular dentist, the dentist is sent a letter describing her participation in the study. Participant Locator Information Form (PLF) Instructions: This information should be obtained from the participant at the time of enrollment. It must be kept strictly confidential and will not be sent to the Data Coordinating Center or computerized. Participant ID: __ __ __ __ __ __ __ __ Participant’s Name: First Middle Last Other names you use or are known by: Participant’s Physician: Participant’s Dentist: Dentist’s Address: Dentist’s Phone: ______________________________ This form should be filled out by the study personnel with the participant present. All sections for which the participant is willing and able to provide information should be completed. It is critical to obtain contact information for some “contact person” who will know the health status and/or location of the participant in the event that they are lost to follow-up. This form is not data entered, and should be stored with other confidential materials to maintain the confidentiality of the study participants. E-mail: Participant’s address: Current Street Address City State Zip How long have you lived at this address? _________________ Other address(es) where you live or receive mail: Street Address City Phone number: Day ( State ) Zip Evening ( Social Security Number: ) E-mail address(es) Date of Birth: State of Birth: Maiden Name: Pager or mobile phone: Marital Status: ( ) Person(s) to contact in case of emergency: (1) Name Relationship Street Address City Phone number: Day ( State ) Zip Evening ( ) (2) Name Relationship Street Address City Phone number: Day ( State ) Zip Evening ( ) Notes: _______________________________________________________________________________________ _____________________________________________________________________________________________ CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 9 3.5. Baseline Visits Scheduling The following baseline data collection phases are required prior to randomization of each participant: Baseline data collection is identified as Visit 02. Obstetrics Baseline Examination Visit Periodontal Baseline Examination Visit Although labeled as visits, these are actually sets or phases of data collection, not required to be unique participant clinic visits. To allow for flexibility at the clinical centers with participant scheduling, the OB Baseline, and Periodontal Baseline visits can occur in any order, including (and preferably) on the same day. All must be complete before the Randomization visit can occur. It is preferable that baseline data collection and their corresponding procedures occur as soon as possible after a participant is enrolled, possibly even during the same clinic visit. However, if the OB baseline visit is to occur on the same day as recruitment, the pelvic exam to collect OB specimens must be conducted prior to any other cervical/vaginal exam. If this is not the case, then the OB Baseline Visit must be scheduled for another day. It is anticipated that some procedures may require an additional scheduled visit to the clinic. Scheduling of these procedures must be made such that Randomization and subsequent periodontal treatment can be completed prior to 23 6 weeks gestation. The OB baseline visit procedures are documented in Chapter 4, of the MOTOR MOP. Periodontal baseline procedures are documented in Chapter 5. 3.6. Participant Log Listings and Tracking The MOTOR DMS will have report features designed to facilitate participant management at the clinical sites. This will include listings of all participants enrolled and randomized, by Participant ID, or by enrollment, randomization, or anticipated due dates. Development of these management reports will be an ongoing feature throughout the study as new information that might help with participant and forms management are identified, and requested from the clinical sites. 3.7. Withdrawing Consent before Randomization Some participants will be recruited, consented, and enrolled but will withdraw consent before randomization, or, will become ineligible for randomization after baseline data is collected. All data collected on participants enrolled, but not continuing, regardless of the reason, will be entered into the MOTOR DMS. This information is important in describing the participant population that was enrolled, as well as the subset of enrollees that were randomized. Chapter 11 of the MOTOR MOP details the CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 10 procedures and documentation required in the event an enrolled participant withdraws consent or is lost to follow-up. CHAPTER 3: Recruitment and Screening 10/10/06 Page 3 - 11