Inter-examiner Agreement of a Novel Device for the Measurement of Cervical Dilation in Labor: A Randomized Controlled Trial
Phase: NA
Conditions: Cervical Dilation, Labor Pain, Labor Fast, Labor; Irregular
Sponsor: Elm Tree Medical Inc.

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TITLE: 
Inter-examiner Agreement of a Novel Device for the Measurement of Cervical 
Dilation in Labor: A Randomized Controlled Trial  
 
NCT Number: 03440723 
  
 
Date of the Document: January 1, 2019 
 

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PROTOCOL 
 
 
TITLE: Inter-examiner Agreement of a Novel Device for the Measurement of Cervical 
Dilation in Labor: A Randomized Controlled Trial 
 
ABBREVIATED TITLE: DilaCheck® Trial 
 
 
PROTOCOL SUMMARY 
 
Measurement of cervical dilation during late pregnancy and labor informs decisions 
in the management of labor and delivery. Prior published research suggests that 
practitioners are only 48 to 56% accurate when judging cervical simulators.1-3 When 
measuring laboring women, two practitioners’ measurements agree only 49% of the 
time.4 Dr. Eva Martin of Elm Tree Medical Inc. (the Sponsor) developed a novel 
device, DilaCheck®, to enable practitioners to increase accuracy in cervical dilation 
measurements.  
 
Elm Tree Medical completed a preliminary trial using a simulator similar to those 
used in prior studies. Fifty Labor and Delivery practitioners completed examinations 
using standard methods and then the device. Standard methods yielded an 
accuracy of 46%. With the device, accuracy increased to 96%, representing an 
108% increase. The device was equally accurate regardless of years of experience 
or level of training. Standard methods resulted in a 10.5% rate of errors of two or 
greater centimeters from the true value. The device eliminated readings that were 
incorrect by more than one centimeter. 
 
The proposed study tests the novel DilaCheck® device in vivo. The target 
population is women presenting to the hospital for evaluation of labor or admitted to 
the Labor and Delivery unit for management of the first stage of labor. The Sponsor 
(Elm Tree Medical Inc.) trains providers working on the Labor and Delivery unit in 
the use of DilaCheck®. After informed consent, each patient participant is 
randomized to receive either two cervical dilation examinations with standard 
methods or two cervical dilation examinations using the device. Two practitioners 
complete the cervical examinations separately. The primary outcome is inter-
examiner agreement between the control and device arms. Secondary outcomes 
include agreement of subjective measurements with DilaCheck® measurements 
over time, agreement of providers’ device readings with a blinded reviewer’s, patient 
and provider satisfaction, and documentation of adverse events. Planned enrollment 
is 50 participants over one year. We hypothesize that the device will increase 
agreement between the two practitioners from about 49% to 90%, as demonstrated 
in the simulator trial. The long-term objective is to validate DilaCheck® for use in 
increasing precision in cervical dilation measurements so that this tool may be 
available to Labor and Delivery providers to enhance quality of care for pregnant 
mothers. Increased precision in cervical dilation measurements will enable providers 

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to make better recommendations for admission to the hospital, augmentation or 
induction of labor, and cesarean section. 
 
The proposed study is a randomized, controlled trial comparing inter-examiner 
agreement of standard methods for measuring cervical dilation to a novel medical 
device. The research population is pregnant women in the first stage of labor.  
 
 
TRIAL PROTOCOL 
 
Eligibility. Subjects eligible for inclusion in the study must be: pregnant women who 
are admitted to a Labor and Delivery unit for management or induction of labor in 
the first stage of labor, are able to give informed consent, are 18 years of age or 
greater, English-speaking, have intact membranes, and have a gestational age 
greater than or equal to 37 weeks (i.e. term pregnancy). Inclusion criteria also 
include having a functioning epidural in place or having provided consent prior to the 
start of labor. Exclusion criteria include progression to the second stage of labor (i.e. 
known dilation of ten centimeters), non-English speaking, known prior rupture of 
membranes, any condition that renders labor unsafe for the patient (e.g. cardiac 
conditions, pulmonary hypertension) and any other condition that necessitates an 
emergent or urgent cesarean section (e.g. non-reassuring fetal status, placental 
abruption, hemorrhage, cord prolapse). Patients are only consented if they have 
adequate pain control, either because they are not yet in labor (i.e. are admitted for 
an induction of labor) or have a functioning epidural. All participants are necessarily 
female due to the subject matter. Given the vulnerability of pregnant patients under 
the age of 18, this study will exclude children. There are no restrictions on eligibility 
based on race or ethnicity. Patients can withdraw from participation at any point in 
the study. DilaCheck® is FDA-cleared for use by qualified healthcare professionals 
for women in pregnancy and labor without any further restrictions. 
 
Provider Enrollment. The Sponsor, TJU Principle Investigator, or trial coordinator will 
discuss participation in the trial with providers at the TJU Labor and Delivery unit. 
Providers will be given the option of participating on a volunteer basis.  
 
Provider Training. The Sponsor will train participating providers in the use of the 
device. The Sponsor will use a detailed script to ensure standardization of the training. 
The Sponsor will use a wooden cervical simulator box to train providers to use the study 
device without patient involvement. The standardized training will test competency with 
the device using the cervical simulator. The providers will also have access to a training 
video to reinforce the in-person training. 
 
Trial Coordination. After training, the Sponsor or the trial coordinator will orient the 
provider to the study protocol and assign every provider a unique Provider Number. 
The trial coordinator will arrange with the hospital staff to conduct the trial at 
scheduled times during the study period. Administration of the trial requires two 
hospital providers who have been trained to use the device, the trial coordinator, 

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and a patient.  
 
Patient Enrollment. Hospital providers will screen patients who have been admitted 
to the Labor and Delivery unit for eligibility. Posters advertising the trial will also be 
displayed on the Labor and Delivery unit. Once identified, hospital providers will ask 
eligible patients if they are interested in participating. If a patient indicates interest, 
the trial coordinator will complete an informed consent. The patient will sign the 
Patient Informed Consent Form. 
 
Randomization. The trial coordinator will assign the participant a Subject Number 
from one to 50, in sequential order. (The first patient enrolled is assigned #1, the 
second enrolled is assigned #2, and so on.) The trial coordinator will then randomize 
the patient to either the Control Group or the Device Group using a randomization 
matrix generated by a computer randomization program. 
 
Data Collection. The trial coordinator will inform two trained providers that the 
patient has agreed to participate in the trial. The trial coordinator will accompany 
one hospital provider to the patient’s hospital room. The second provider will wait 
outside the room, in a place where s/he cannot hear the interaction in the room. The 
trial coordinator will re-affirm consent with the patient. 
 
If the patient is randomized to the Control Group: The first provider will introduce 
him/herself and inform the patient that s/he is going to conduct a cervical 
examination. The trial coordinator will record the time of the first exam. The provider 
will complete a cervical examination following the standard techniques s/he uses on 
a regular basis, using sterile gloves. The provider will dispose of the gloves. The first 
provider will write his/her measurement of cervical dilation on the first Data 
Collection Form and fold the sheet of paper. Readings may be integers or fractional 
answers. The coordinator will take the folded sheet of paper and will not read the 
value. The first provider will then leave the hospital room. S/he will not speak to the 
second provider.  
 
The second provider will enter the hospital room. The second provider will introduce 
him/herself to the patient and explain that s/he is going to perform a cervical 
examination. The trial coordinator will record the time of the second exam. The 
second exam must be completed within 10 minutes of the first exam. The second 
provider will complete a cervical examination following standard techniques. The 
provider will write his/her measurement of cervical dilation on a second Data 
Collection Form, fold the form, and hand it to the trial coordinator. Readings may be 
integers or fractional answers. The second provider will leave the room. 
 
If the patient is in the Device Group: The first provider will introduce him/herself and 
inform the patient that s/he is going to conduct a cervical examination and confirm 
that the patient is ready to proceed. The trial coordinator will record the time of the 
first exam. The first provider will complete a cervical examination with a DilaCheck® 
device and sterile gloves using the techniques taught during training.  

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During or after the examination, before looking at the DilaCheck® device or his/her 
hand, the provider will verbally report his/her subjective cervical dilation 
measurement to the trial coordinator. Readings may be integers or fractional 
answers. The trial coordinator will record this number. The first provider will then 
look at the DilaCheck® device and read the measurement from the DilaCheck® 
measuring tape.  
 
The trial coordinator will take a photograph from a secure camera of the DilaCheck® 
measurement. The trial coordinator may choose to take multiple photographs to 
ensure a clear image is captured. The coordinator and provider will use a neutral 
background to ensure no private health information (such as an image of the patient 
participant or hospital room) is included in the photograph. A white sheet of paper 
with the subject number will be provided to serve as a blank, secure background for 
the photograph(s).  
 
The first provider will record two readings of the DilaCheck® measurement. The 
provider will write his/her measurements on the first Data Collection Form, fold the 
form, and hand it to the trial coordinator. The first will be his or her reading of the 
exact DilaCheck® measurement, which may be a fraction (any fraction). The second 
reading will be his or her reading of the DilaCheck® measurement rounded to the 
nearest integer; i.e. the second response can only be an integer, not a fraction. 
 
The first provider will dispose of the gloves and device. The first provider will then 
leave the hospital room. S/he will not speak to the second provider.  
 
The second provider will enter the hospital room. The second provider will introduce 
him/herself to the patient and explain that s/he is going to perform a cervical 
examination. The trial coordinator will record the time of the second exam. The 
second exam must be completed within 10 minutes of the first exam. The second 
provider will complete a cervical examination as above using a DilaCheck® device. 
The second provider and trial coordinator will repeat the same steps as described 
above for the first provider. The second provider will leave the room. 
 
Patient Survey. The trial coordinator will then ask the patient to answer the 
questions on the Patient Survey. The survey will elicit relevant biological and 
demographic variables including age, race, ethnicity, gestational age, weight, and 
use of epidural anesthesia. It will assess the patient’s discomfort with the 
examinations, confidence in the accuracy of the measurements, and satisfaction 
with the examinations. Patients will be asked to report any side effects they 
experienced and to provide any comments they have. 
 
Patient Reimbursement. The trial coordinator will offer the patient a $25 gift 
certificate to thank her for participating. The patient will sign a receipt to confirm that 
she received the gift certificate. 
 

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Provider Survey. At the end of the trial, the trial coordinator will ask all participating 
providers to complete the Provider Survey. The survey will elicit the provider’s years 
of experience, role on Labor and Delivery, opinions about inter-examiner agreement 
using standard methods and using DilaCheck®, and ease of use and satisfaction 
with the device. The survey will ask whether providers experienced any adverse 
events and if their patients experienced any adverse events during the trial. They 
will have the option to provide comments. 
 
Photograph Review. The Sponsor will train an independent reviewer to read 
DilaCheck® measurements. The reviewer will be provided the photographs taken of 
DilaCheck® measurements. The reviewer will report two measurements for each 
photograph. The first will be his/her reading of the exact DilaCheck® measurement, 
which may be a fraction. The second reading will be his/her reading of the 
DilaCheck® measurement rounded to the nearest integer; i.e. the second response 
can only be an integer, not a fraction. 
 
Continuous Feedback. After any individual provider completes five examinations 
with DilaCheck®, the provider will be provided feedback about whether his/her 
DilaCheck® measurement readings match those of the independent reviewer. 
 
Power Calculation. The planned enrollment in the study is 50 patients. The 
following assumptions were used for the power calculations. The agreement in the 
Control Group was projected to be 49%,4 and the agreement in the Device Group 
was projected to be 90%, based on the results of the simulator trial. The standard 
deviation was projected to be 23, also based on the standard deviation in the prior 
simulator trial. With a two-tailed test with alpha=0.05, a sample size of five yields 
80% power. However, a trial with five participants will not yield the desired 
robustness in evaluation of a novel medical device. Instead, a sample size of 25 
subjects in each group is planned to allow for examinations across a wide range of 
patients and providers. A sample size of 50 yields a power of 100% to detect a 
difference between the two methods given the above assumptions.  
 
Statistical Analysis. The statistical analysis will use a two-tailed level of 
significance of 0.05. Using SPSS, the proportion of examinations in each group for 
which the two providers’ examinations differed will be determined. A Students T test 
will be performed to determine whether this difference is significant. The number of 
examinations for which providers’ answers differed by one centimeter and by two or 
more centimeters for each group will be determined. A Students T test will be 
performed to determine if the frequency of variation of one centimeter significantly 
differed between groups. A Students T test will be performed to determine if the 
frequency of variation of two or more centimeters significantly differed between 
groups. These analyses will be completed for both the fractional and integral (non-
fractional) sets of DilaCheck® measurement readings.  
 
 
For participants in the DilaCheck® arm, the subjective and DilaCheck® 

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measurements will be plotted along an X-Y axis and the Pearson correlation 
coefficient between the two data sets will be calculated. This analysis will be 
completed for both the fractional and integral (non-fractional) sets of DilaCheck® 
measurement readings.  
 
The photographs of the DilaCheck® measurements will be read by an independent, 
blinded reviewer to report the DilaCheck® measurements. The provider’s and 
reviewer’s DilaCheck® measurements will be plotted along an X-Y axis and the 
Pearson correlation coefficient between the two data sets will be calculated. This 
analysis will be completed for the fractional and integral (non-fractional) sets of 
DilaCheck® measurement readings. 
 
The correlation between the providers’ subjective and DilaCheck® measurements 
will be analyzed over time. To do so, for providers who complete at least 10 exams, 
the correlation of the two measurements in the provider’s first half of examinations 
will be compared to the providers’ second half of measurements. A T-test will be 
completed to determine whether the two correlations differ significantly. The 
analysis will be repeated for both the fractional and integral (non-fractional) sets of 
DilaCheck® measurement readings and using the data sets of readings from the 
independent reviewer. 
 
The average pain score in each group will be calculated, and a Students T test will 
be performed to determine whether pain scores differed significantly between 
groups. Using logistic regression whether provider number, patient age, gestational 
age, weight, or epidural status significantly impacted likelihood of agreement or pain 
score within each group will be determined. The average provider confidence in 
accuracy will be calculated, and a Students T test will compare if patients’ 
confidence differs significantly between groups. Logistic regression will be used to 
determine if provider experience or training significantly predicted likelihood of 
agreement.  
 
Any additional statistical analysis appropriate for the data collected will be 
performed. For the qualitative data, including descriptions of adverse events and 
feedback, each of the responses will be reviewed individually. Any serious adverse 
events will be reported. Any informative feedback or themes in the feedback will 
also be collated.  
 
With regard to missing data, if a patient is missing one or both of the cervical dilation 
readings, she will be excluded from analysis of the primary outcome. However, if 
she has filled out a survey, this data will be used in the analysis of secondary 
outcomes since it may include important data accounting for why the patient was 
unable to have both examinations.  If a patient or provider is missing one or more 
answers to a survey question, then the response to that question will be omitted 
from the analysis. The statistical analysis will not include imputing missing data. 
 
The Sponsor will provide the trial coordinator, principle investigator, and other 

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involved TJU staff access to the statistical analysis and article draft and provide 
them with time to provide feedback and insight into all statistical analyses.  
 
Study Device Specifications. There are no hazardous materials involved in this 
trial. The study device is made of soft, medical grade, biocompatible components. 
The device is sterilized using gamma radiation. The device is not anticipated to 
present any risk above that of a standard cervical dilation examination with a sterile 
glove. It is tested for reliability, and all components have multiple attachment points 
so that if one attachment point fails, it will still be attached to another component or 
the provider’s hand and thus will not be left in the patient.  
 
Bias. Unfortunately, it is not feasible to blind patients and providers to group 
assignment. However, keeping the second provider blinded to the first provider’s 
measurement will decrease bias. Randomization using a computer generation 
program will also eliminate assignment bias. 
 
Potential Problems. Given the acuity of Labor and Delivery, one anticipated 
challenge is enrollment. Women in labor may be hesitant to participate in any 
clinical trial or to participate in the validation of a novel device. We will offer a small 
incentive for participation via a modest gift certificate of a size not large enough to 
coerce patients into participating. The trial coordinator will answer any questions the 
patient has regarding the trial and respond to any concerns that arise in an open, 
patient, and honest manner. 
 
Another potential problem is clinician participation. Clinicians will be incentivized to 
participate through the potential for inclusion in the publication and an appeal to the 
greater good of scientific research and the betterment of our management of labor 
and delivery. TJU has an excellent record of clinician participation in trials. A related 
potential problem is training clinicians in using the device. In the prior simulator trial, 
device training was accomplished in less than one minute, but in this trial we will 
dedicate more time to training as well as testing the accuracy of the clinician during 
the training using simulators. The Sponsor will travel to TJU and provide trainings. 
 
Benchmarks. Benchmarks include training at least two hospital providers to use the 
device and enrolling at least 6 patients monthly. If any of these benchmarks is 
lagging behind estimates, the Sponsor will consult with the hospital to create a plan 
to address the issue. 
 
PROTECTION OF HUMAN SUBJECTS 
Human Subjects. This clinical trial necessitates the involvement of human subjects in 
order to validate the novel medical device for use in humans. The prior simulator trial 
verified the concept, but until a trial is conducted in humans, the true value of the device 
is unknown. Furthermore, it is of the utmost importance to study the device in a setting 

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with strict procedures in place to monitor for serious or unexpected adverse events. The 
trial will comply with federally mandated regulations per 45 CFR 46. 
Institutional Host. TJU Hospital will physically host the study, provide patients for 
potential enrollment, and provide the hospital providers to complete the cervical 
examinations. We will obtain approval from the TJU IRB prior to enrollment. The trial 
coordinator is a TJU employee and will work with Labor and Delivery staff to schedule 
appropriate times to enroll patients and collect data. 
Involvement and Characteristics of Human Subjects. The subject population is 
women presenting to the hospital for evaluation of a diagnosis of labor and women 
admitted to the hospital Labor and Delivery unit for management of the first stage of 
labor. Planned enrollment is 50 patients. The subject population is reproductive aged, 
pregnant women with stable health. In order to be eligible for the trial, a woman must 
have a term pregnancy (≥37 weeks gestation) and be able to complete informed 
consent. Only patients presenting to or admitted to the Labor and Delivery unit for 
management of labor are eligible. For instance, a patient presenting to her clinician’s 
office for a routine prenatal appointment is not eligible, or a patient admitted to the 
Labor and Delivery unit for a scheduled cesarean section who is not in labor is also not 
eligible. Exclusion criteria include advancement to the second stage of labor, any 
condition that renders labor unsafe for the patient, and any other condition that 
necessitates an emergent or urgent cesarean section. This will ensure exclusion of 
patients with unstable medical situations. This clinical trial necessarily involves the 
participation of a vulnerable population, pregnant women, because the device is 
intended for use in pregnant women. All of the conditions outlined in 45 CFR part 46 
Subpart B are met. 
Sources of Research Material. This trial does not use any biological samples or 
hazardous materials. The data collected from human subjects includes: records of two 
cervical dilation measurements, photograph of the device reading, age, race, ethnicity, 
gestational age, weight, discomfort ratings, epidural status, confidence in accuracy, 
patient satisfaction, side effects, and comments. The data collected from providers 
includes: beliefs about agreement of standard cervical dilation measurements, beliefs 
about agreement of measurements with DilaCheck®, years of experience on Labor and 
Delivery, role on Labor and Delivery, provider side effects, patient side effects, ease of 
use of the device, satisfaction with the device, and comments.  
Potential Risks of Study Participation. The device is not anticipated to present any 
risk above that of a standard cervical dilation examination with a sterile glove. Potential 
risks to the patient include loss of confidentiality, discomfort with cervical examinations, 
a theoretical increased risk of infection, rupture of membranes, and inconvenience. For 
the provider, there is not anticipated to be any risk above that of performing a standard 
cervical dilation examination with a sterile glove. 
Recruitment and Informed Consent. The sampling plan will ensure that all eligible 
patients are offered the opportunity to participate, regardless of race, ethnicity, or 

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socioeconomic status. The trial coordinator will consent patients in a private room or 
area. Consent will be documented with signatures of the trial coordinator and the patient 
on the Patient Informed Consent Form. Patients will receive a copy of the Patient 
Consent Form. 
Randomization. Patients will be randomized to a treatment group using a computer-
generated randomization program to eliminate assignment bias.  
Confidentiality. Only the trial coordinator, the Sponsor, and the PI will have access to 
individually identifiable private information about human subjects. The hospital providers 
will likely have access to this information through the hospital medical record, but they 
will not be provided with the data through participation in the trial. The trial coordinator 
will store trial materials in a locked space at TJU. All physical materials obtained by Elm 
Tree Medical will be stored in a locked file at the Elm Tree Medical Inc. office. The trial 
coordinator will provide Elm Tree Medical with an electronic report of data collected. 
Any data entered into electronic form on TJU or Elm Tree Medical computers will be 
password-protected. 
Risks Related to the Study Device. To protect patients against any risk from 
exposure to the device, the devices will be manufactured under Design Controls and 
Good Manufacturing Practices, and documentation of biocompatibility and sterility 
testing of all components can be made available prior to their use. The device was 
designed to maximize safety and comfort with all soft, medical grade components. 
The manufacturer tests the devices for reliability. If the device fails in any way, both 
the trial coordinator and the provider will confirm that all components have been 
removed fully from the patient. To minimize risk from using a previously untested 
device, the results of the examinations will not be used in patients' clinical care. 
 
Discomfort. Patients will be reminded that they may withdraw from the study at any 
time, including after the first examination if they found it too uncomfortable to 
consent to a second examination. Providers will minimize discomfort through 
standard techniques such as confirming that the patient would like to continue the 
procedure before and during an examination. Most women receive epidurals in labor 
and are thus unlikely to have pain with examinations.  
 
Increased Risk of Infection. The connection between cervical examinations and 
infection is controversial. Theoretically, insertion of anything into the vagina, even a 
sterile gloved finger, could introduce bacteria and cause maternal fever and 
chorioamnionitis. However, recent research has failed to support this theory. For 
instance, a 2012 trial of 2,395 women revealed no association between number of 
cervical examinations and intrapartum maternal fever.6 Therefore, an additional 
examination confers at most minimal additional risk of infection to the patient. The 
device is sterilized using gamma radiation, and we will complete confirmatory testing 
of sterilization methods prior to shipping the device from the manufacturer. 
 
Unintentional Amniotomy. Unintentional amniotomy is equally likely with the 

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device and with standard methods since the device has all soft components. If 
amniotomy is planned, it will be carried out following the two examinations in order 
to reduce the theoretical risk of infection with examinations following rupture of 
membranes. 
 
Inconvenience. Providers will not pressure patients into participating and will 
clearly inform them that participation is entirely optional and will have no effect on 
care. The trial will be carried out in an efficient manner with attention paid to 
minimizing use of the providers’ and patients’ time. 
Risks to Providers. If the Labor and Delivery unit is too busy, providers may opt out of 
participation for that shift. The study will monitor for any adverse events experienced by 
the provider through the survey given to all providers at the end of a trial session.  
Protection of Vulnerable Populations. This trial meets all conditions as listed in 
45 CFR part 46 Subpart B. A simulator trial was conducted as a preclinical study to 
provide data prior to testing the device with pregnant women. Documentation of 
sterility and biocompatibility testing of the device materials in vitro can be made 
available prior to use in the trial. There is minimal risk to the fetus, and these risks 
have been minimized as much as possible for achieving the objectives of the 
research. The device holds the prospect of direct benefit to both pregnant women 
and fetuses. The purpose of the research is the development of important 
biomedical knowledge: determination of the efficacy and safety of this novel device 
that cannot be obtained by other means. Researchers will obtain consent from every 
patient in accordance with the informed consent provisions of 45 CFR 46 Subpart A. 
No pregnancies will be terminated. There is no contact with neonates. 
Potential Benefits of the Proposed Research to Human Subjects and Others. 
Human subjects will benefit from participating in the research through their receipt of 
education on cervical dilation examinations via the consent process and through the 
knowledge that they have contributed to the care of future laboring women. Providers 
will benefit from participation through receiving individualized training in the use of the 
device, through gaining experience in clinical trials, and through the option to participate 
in editing the scholarly journal article in exchange for authorship. Because patients are 
exposed to a non-significant level of risk by participating in the study, the benefits to 
them, to providers, and to the field of obstetrics and future laboring mothers outweighs 
the risks. 
Importance of the Knowledge to be Gained. The greatest benefit of the proposed 
research is the validation of a new device that could revolutionize labor management. If 
successful in increasing inter-examiner agreement, DilaCheck® has the potential to 
increase certainty in the management of labor, decrease length of admissions to the 
Labor and Delivery unit, decrease unnecessary interventions and cesarean sections, 
and decrease the time a woman is in labor. Since the device is not anticipated to 
expose patients to any significant risks, this potential for a vast benefit to laboring 
mothers and newborns far outweighs the risks to participants. 

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DATA AND SAFETY MONITORING PLAN 
TJU IRB Review. We will submit a detailed monitoring plan to the TJU IRB for review 
and approval prior to initiation of the trial. All serious adverse events (AEs) will be 
reported to the TJU IRB within one week of the investigator becoming aware of the 
event. Any unanticipated problems will be reported to the TJU IRB within two weeks. 
The TJU IRB also requires interim reviews of the trial, either every six or 12 months, as 
determined by the IRB upon initial review of the protocol. The continuing review is 
submitted through completion of the "Continuing or Final Review of Research Protocols 
Involving Human Subjects" form. It includes enrollment data, adverse event reporting 
(including identification of adverse events not anticipated in the consent form), 
increased risks identified since the last review, demographics of enrolled patients, 
withdrawal of patients, loss to follow up, subject complaints, protocol changes, interim 
findings, assurance of an up-to-date literature review by the PI, changes to FDA status, 
and conflicts of interest. We will submit this form to the TJU IRB every six or 12 months, 
per the IRB's designation. 
Sponsor Review. The Sponsor will review all data collected from the prior month at the 
beginning of each month. If there are serious AEs, she will report them to the necessary 
institutions.  
DSMB Review. The DSMB consists of four volunteer experts in the following fields: 
obstetrics, clinical trials, law, and ethics. Because they are volunteers, they do not stand 
to benefit from continuing the trial if it is not in the best interest of participants. The 
Sponsor will compile a document with enrollment data, lists of all adverse events, and 
summary statistics of data collected up to that date on a monthly basis. All information 
will be de-identified. The Sponsor will distribute the document via email to the members 
of the DSMB on the last Friday of each calendar month for the prior month’s data. The 
DSMB members will review the document. If there are unexpected or serious AEs, the 
DSMB will determine whether continuation of the trial is safe. They will have the power 
to discontinue the trial at any time if they feel continuation is not in the best interest of 
patients. The Sponsor will be responsible for reporting a trial discontinuation due to 
safety concerns to the necessary regulatory bodies. 
NIH/ Funding Institution & Center (IC). This trial has been accepted for funding from a 
STTR grant. The funding IC for this trial is the Eunice Kennedy Shriver National Institute 
of Child Health & Human Development (NICHD). The Sponsor will submit a monitoring 
plan to the NICHD Program Officer (PO) before the trial begins. During the trial, the 
Sponsor will inform the NICHD PO of any recommendations and activities that emanate 
from monitoring activities. The Sponsor will submit summary reports of the DSMB’s 
discussions to the NICHD PO on a monthly basis as they become available. All 

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unanticipated problems and serious adverse events will be reported to the NICHD PO 
within one month of the IRB’s receipt of the report of the problem from the Sponsor. 
FDA. The FDA has cleared DilaCheck® as a Class 1 low risk device. The original 
device design was cleared by a 510(k) application. Because the current design 
represents such a low (non-significant) risk, it is considered Class 1 exempt and does 
not require FDA clearance of a 510(k) application prior to marketing. Pre-market 
obligations have been documented via a “Letter to File,” and the device is registered 
with the FDA. The FDA has not withheld or restricted the device. 
The Sponsor has contracted with the regulatory consultancy, ProMedic Inc., to submit 
all necessary reports. The FDA will receive the results of an evaluation of an 
unanticipated adverse device effect after the Sponsor receives notice of the adverse 
effect or notification of withdrawal of IRB approval within five working days of receipt of 
the withdrawal of approval. All serious AEs will be reported to the FDA within one week 
if fatal or life threatening and within 15 days otherwise. The device represents a non-
significant risk, so we will not submit annual reports or a final report to the FDA. The 
Sponsor will provide accurate, complete, and current information about any aspect of 
the investigation upon request from the FDA. 
Office for Human Research Protections (OHRP). All unanticipated problems and 
serious adverse events will be reported to the OHRP within one month of the IRB’s 
receipt of the report of the problem from the investigator. We will comply with all OHRP 
regulations. 
ClinicalTrials.gov. Prior to initiating enrollment, the Sponsor or trial coordinator will 
register the trial on ClinicalTrials.gov. The NIH Grant Number will be included. The 
Sponsor will report summary results information (including AEs) on ClinicalTrials.gov no 
later than one year after the completion date of the clinical trial. Grant and progress 
report forms will include a certification that the Sponsor (the responsible party) has 
made all required submissions to ClinicalTrials.gov. 
 
INCLUSION OF WOMEN AND MINORITIES 
 
Planned Distribution. All participants will be female because the research requires the 
patient to be pregnant. In 2014, the racial/ethnic distribution of births in the United 
States was similar to the population distribution of Philadelphia.5,7 The study population 
will be typical of the racial/ethnic distribution in Philadelphia. A racial/ethnic distribution 
mirroring the general obstetrics population is favorable for the scientific goals of this 
study because the primary goal is to test the device for use in a general obstetrics 
population. 
 

DilaCheck® Trial 
Confidential 
14 
Selection criteria. All patient participants must be female. There are no inclusion or 
selection criteria based on race or ethnicity. There is no prior research demonstrating a 
difference in accuracy of cervical dilation readings based on race or ethnicity and no 
anatomic or biologic reason for a difference to exist.  Therefore, inclusion of all races 
and ethnicities is reasonable. 
 
Exclusion. Males must necessarily be excluded because they are not candidates for 
use of this obstetrics product. There are no exclusion criteria based on race or ethnicity. 
 
Outreach. Patients will be recruited after they arrive at the Labor and Delivery 
department if they meet medical eligibility criteria without regard to their race or 
ethnicity. Because TJU serves a diverse population of expecting mothers, enrollment is 
expected to mirror this distribution. 
 
 
BIBLIOGRAPHY 
 
1. Tuffnell, D, Bryce, F, Johnson, N, Lilford, R. Simulation of Cervical Changes in 
Labour: Reproducibility of Expert Assessment. Lancet. 1989 Nov;2(8671):1089-90. 
2. Phelps J, Higby K, Smyth M, Ward J, Arredondo F, Mayer A. Accuracy and 
Intraobserver variability of simulated cervical dilatation measurements. Am J Obstet 
Gynecol. 1995 Sep;173(3 Pt 1):942-5.  
3. Huhn K, Brost B. Accuracy of simulated cervical dilation and effacement 
measurements among practitioners. Am J Obstet Gynecol. 2004 Nov;191(5):1797-9. 
PMID 15547567. 
4. Buchmann E, Libhaber E. Accuracy of cervical assessment in the active phase of 
labour. BJOG. 2007 Jul;114(7):833-7.  
5. Martin JA, Hamilton BE, Osterman MJ. Births in the United States, 2014. NCHS Data 
Brief. 2015 Sep;(216):1-8.  
6. Cahill AG, Duffy CR, Odibo AO, Roehl KA, Zhao Q, Macones GA. Number of cervical 
examinations and risk of intrapartum maternal fever. Obstet Gynecol. 2012 
Jun;119(6):1096-101. 
7. QuickFacts: Philadelphia city, Pennsylvania. United States Census Bureau. 2010. 
http://www. census.gov/quickfacts.