Download 3.1. Initial Contact, Recruitment, Pre

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:
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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:
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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.
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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.
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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.
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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
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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:
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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
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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:
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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:
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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:
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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
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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.
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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: _______________________________________________________________________________________
_____________________________________________________________________________________________
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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.
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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
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procedures and documentation required in the event an enrolled participant withdraws
consent or is lost to follow-up.
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