Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A Randomized Controlled Trial
Phase: NA
Conditions: Labor
Sponsor: Angela Bianco

NCT03138798
Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A 
Randomized Controlled Trial
PI: Angela Bianco
Document Date: 10/27/2017

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IRB-16-00761
Amendment
1. Modification
Summary of the Modification Request
We determined prior to enrollment (but after initial approval) that  our sample size needed to be extended to 348 total
 patients in order to be powered to detect a 20% difference in total pushing time.
Justification for the Modification
After initial study approval by the IRB, but prior to actually beginning enrollment, our team re-calculated our power
 analysis because we realized we did not account for the fact that the duration of the second stage of labor is not a
 normally distribute variable. For this reason, at the onset we recalculated the sample size. In order to be powered
 to detect a 20% reduction in pushing time, we need a total of 348 patients enrolled (174 patients per arm). We are
 requesting approval to enroll for a total of 348 patients.
This Modification Changes
 the Consent Document or
 Information that May Affect
 Subjects’ Willingness to Continue
 to Participate in the Research
Yes
Description of Changes in the Consent Document or Information that May Affect Subjects’ Willingness to
 Continue to Participate in the Research
This only changes the wording of the section of the consent labelled "Length and Time and Number of People
 Expected to Participate". I have attached both the modified versions with/without tracked changes. Otherwise, these
 changes will not have any effect on patients' willingness to continue to participate.
Subjects Will Be Re-Consented or
 Provided with the New Information
No
Explanation Why Re-Consenting or Providing Subjects with the New Information is Not Necessary
The modification does not affect previously enrolled patients in our study.
Page 1 of 25

IRB-16-00761
Amendment
2. Summary - Title
Protocol Title
Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A Randomized Controlled Trial 
Principal Investigator
Angela Bianco
When the application is complete, it will be sent to the PI for submission
When the application is complete, it will be sent to the PI for submission
Primary Department
Obstetrics/Gynecology
When the application is complete, it will be sent to the PI for submission
Application Initiated By
Eric Bergh
Lay Summary
In an effort to reduce the rate of cesarean section, obstetric practices now allow for prolonged second stage of labor
 to accomplish vaginal delivery. However, this practice is not without risks and may lead to either operative delivery
 (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. While the use
 of a dental support device in labor is not yet standard of care, limited evidence suggests that using such a device
 while pushing may improve maternal valsava and lead to a shortened second stage of labor by allowing them to
 push more effectively. Previous studies have been underpowered to find statistically significant results.
At our institution, we have a unique and heterogeneous inner-city population of laboring mothers with marked rates
 of maternal obesity. Our objective is to conduct a randomized controlled trial in which nulliparous patients are asked
 to use a dental support device throughout the entirety of the second stage of labor (while pushing with contractions).
 Our primary outcome is the duration of the second stage. Secondary outcomes will include cesarean section and
 operative delivery rates, as well as combined maternal and neonatal morbidity (Rates of post-partum hemorrhage,
 chorioamnionitis, perineal trauma, fetal weight, neonatal apgars etc…).
In this study we will use the dental support device, Laboraide, produced by Medivie. The device has Class 1 FDA
 approval, under the classification of non-fluid filled teething-ring device. Premarket review by the FDA was performed
 by the following FDA departments: Office of Device Evaluation (ODE), Division of Anesthesiology, General Hospital,
 Infection Control, and Dental Devices (DAGRID) and Dental Devices Branch (DEDB). The device is marketed
 to laboring patients in the US and Europe to potentially help reduce pain and more efficiently produce a valsalva
 while pushing in labor. Finally, the device is not currently in use at MSSM. It will be purchased through OB/GYN
 departmental research funds and it is only being purchased for use in this study.
IF Number
IF1937858
Page 2 of 25

IRB-16-00761
Amendment
3. Summary - Setup
Funding Has Been Requested /
 Obtained
No
Application Type
Request to Rely on Mount Sinai IRB
Research Involves
Prospective Study ONLY
Consenting Participants
Yes
Requesting Waiver or Alteration
 of Informed Consent for Any
 Procedures
No
Humanitarian Use Device (HUD)
 Used Exclusively in the Course of
 Medical Practice
No
Use of an Investigational Device to
 Evaluate Its Safety or Effectiveness
No
Banking Specimens for Future
 Research
No
Cancer Related Research that
 Requires Approval from the
 Protocol Review and Monitoring
 Committee (PRMC).
No
   Is this Cancer Related Research?  Cancer Related Research is defined as research that
 has cancer endpoints or has a cancer population as part of or all of its targeted population.
 This includes protocols studying patients with cancer or those at risk for cancer.
Clinical Trial
Yes
* A prospective biomedical or behavioral research study of human subjects that is
 designed to answer specific questions about biomedical or behavioral interventions
 (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices). 
* Used to determine whether new biomedical or behavioral interventions are safe,
 efficacious, and effective. 
Drugs / Biologics 
No
* Drugs / Biologics That Are Not a Part of Standard Practice
* Controlled Substances
* Drugs / Biologics Supplied by the Research Sponsor or Purchased with Study Funds
   Ionizing Radiation for imaging or therapy, including X-Ray, Fluoroscopy, CT, Nuclear
 Medicine, PET andor Radiation Therapy:
* Purely for standard of care:
No
* In frequency or intensity that
 exceeds what is necessary for
 standard of care:
No
Hazardous Materials
No
* Recombinant DNA

* Viral Vectors
* Plasmids
* Bacterial Artificial Chromosomes
* Toxic Chemicals, Potentially Toxic Medications, Carcinogens
* Autologous Cell Lines
Request Use of Clinical Research
 Unit Resources
No
Page 4 of 25

IRB-16-00761
Amendment
4. Summary - Background
Objectives
To determine if the use of a dental support device in the second stage of labor will decrease the time to vaginal
 delivery in an inner city population.
Background
Over the last several decades the rate of cesarean section has risen significantly in the United States to
 approximately 33% in 2013. This is particularly alarming given the increased risk for major maternal morbidity
 including abnormal placentation and hemorrhage associated with multiple repeat cesarean sections. In an effort to
 reduce the rate of cesarean section, obstetric practices now allow for prolonged second stage of labor to accomplish
 vaginal delivery. However, this practice is not without risks and may lead to either operative vaginal delivery (vacuum
 or forceps assisted delivery) or cesarean section. Maternal complications associated with these outcomes include
 higher rates of postpartum hemorrhage, febrile morbidity and perineal trauma. Furthermore, a prolonged second
 stage increases the risk for NICU admission, neonatal sepsis and asphyxia as well as lower Apgar scores.[1] 
Techniques to increase the effectiveness of pushing may lead to a shortened second stage.
Dental support devices may improve maternal valsava through several mechanisms. These include increased muscle
 strength in different muscle groups[2-5], increased isometric endurance during the pushing phase[6], increased
 maintenance of physical activity[7], and optimization of head and neck posture, causing increased cervical muscle
 strength and enhancing the valsalva maneuver, which increases the intrauterine pressure[8, 9] Matsuo et al. [9]
 conducted a pilot study in which nulliparous women were randomized to a dental support device during the second
 stage and found a reduction in the duration of pushing. Because it was a pilot study, it was not powered to find
 statistically significant results. This was followed by a randomized controlled study by Aviram et al. [10] in which
 nulliparous Israeli women selected at random were asked to use the device while pushing in labor. They found
 a reduction in the rate of obstetric interventions (cesarean section and operative vaginal delivery) performed for
 prolonged second stage, however no difference was found in the overall duration of the second stage between
 groups. A major limitation was the requirement that experimental subjects only push with the device for a total of 10
 minutes during the second stage. Furthermore, their population included women with an average pre-pregnancy BMI
 of 22 and they used a per-protocol analysis rather than intention-to-treat. 
There have been no further studies to investigate the role of dental support devices in the second stage of labor. The
 existing evidence suggests that women who are actively pushing in labor may benefit from improvements in strength,
 endurance and posture which may be attained using a dental support device.[9, 10] At our institution, we have a
 unique and heterogeneous inner-city population of laboring mothers with marked rates of maternal obesity. In line
 with national trends, our cesarean section rate has risen over the last several decades. We welcome any intervention
 which may reduce the duration of the second stage and thereby reduce maternal and neonatal morbidity and the
 need for obstetric interventions such as cesarean section or operative delivery. 
Our objective is to conduct a randomized controlled trial in which nulliparous patients are asked to use a dental
 support device throughout the second stage of labor. Our primary outcome is the duration of the second stage.
 Secondary outcomes will include cesarean section and operative delivery rates, as well as combined maternal and
 neonatal morbidity (Rates of post-partum hemorrhage, chorioamnionitis, perineal trauma, fetal weight, apgars etc…) 
1. Laughon, S.K., et al., Neonatal and maternal outcomes with prolonged second stage of labor. Obstet Gynecol,
 2014. 124(1): p. 57-67.
2. Carr, A.B., et al., Postural contractile activities of human jaw muscles following use of an occlusal splint. J Oral
 Rehabil, 1991. 18(2): p. 185-91.
3. Forgione, A.G., et al., Strength and bite, Part 2: Testing isometric strength using a MORA set to a functional
 criterion. Cranio, 1992. 10(1): p. 13-20.
4. Forgione, A.G., N.R. Mehta, and W.L. Westcott, Strength and bite, Part 1: An analytical review. Cranio, 1991. 9(4):
p. 305-15.
5. Parker, M.W., et al., Muscle strength related to use of interocclusal splints. Gen Dent, 1984. 32(2): p. 105-9.
6. Chakfa, A.M., et al., The effect of stepwise increases in vertical dimension of occlusion on isometric strength of
 cervical flexors and deltoid muscles in nonsymptomatic females. Cranio, 2002. 20(4): p. 264-73.
7. Ishijima, T., et al., The relationship between occlusal support and physical exercise ability. J Oral Rehabil, 1998.
 25(6): p. 468-71.
8. Buhimschi, C.S., et al., Use of McRoberts' position during delivery and increase in pushing efficiency. Lancet,
 2001. 358(9280): p. 470-1.
9. Matsuo, K., et al., Duration of the second stage of labor while wearing a dental support device: a pilot study. J
 Obstet Gynaecol Res, 2009. 35(4): p. 672-8.
10. Aviram, A., et al., The effect of intrapartum dental support use among nulliparous during the second stage of labor
 - a randomized controlled study. J Matern Fetal Neonatal Med, 2016. 29(6): p. 868-71.

11. Hansen, S.L., S.L. Clark, and J.C. Foster, Active pushing versus passive fetal descent in the second stage of
 labor: a randomized controlled trial. Obstet Gynecol, 2002. 99(1): p. 29-34.
Primary and Secondary Study Endpoints
The primary outcome will be duration of the second stage to vaginal delivery. Secondary outcomes include mode of
 delivery, estimated blood loss, uterine atony, chorioamnionitis as well as neonatal outcomes (i.e. birth weight, apgar
 scores, NICU admission).
Protocol Was Already Approved
 by the Icahn School of Medicine at
 Mount Sinai (ISMMS) Institutional
 Review Board (IRB) Under a
 Different Principal Investigator
No
Protocol Was Previously Submitted
 to an External(non-ISMMS) IRB
No
Page 6 of 25

IRB-16-00761
Amendment
5. Research Personnel
Name/Department
Role/Status
Contact
Access
Signature
 Authority
Phone
Email
Angela Bianco /
 Obstetrics/
Gynecology
Principal
 Investigator / 
Signature
 Authority
Eric Bergh / 
CI / 
Signature
 Authority
Luciana Vieira / 
CI / 
Edit
 Access
Katherine Connolly / CI / 
Edit
 Access
Stephanie Factor / 
CI / 
Edit
 Access
Joanne Stone / 
CI / 
Edit
 Access
Brittany Noel
 Robles / 
ARC / 
Edit
 Access
Catherine Bigelow / 
CI / 
Edit
 Access
Patricia Rekawek / 
CI / 
Edit
 Access
Amrin Khander / 
CI / 
Edit
 Access
Jessica
 Spiegelman / 
CI / 
Edit
 Access
Page 7 of 25

IRB-16-00761
Amendment
6. Sites
Site Name
Icahn School of Medicine at Mount Sinai
Other External Site Name
Contact Details
Approved
Approval Document
Funded By Mount Sinai
Other IRB
Page 8 of 25

IRB-16-00761
Amendment
7. Subjects - Enrollment
Site Name
Icahn School of Medicine at Mount Sinai
Subjects To Be Enrolled
348
Total Number of Subjects to be
 Enrolled Across All Listed Sites
 Above (Auto Populated)
348
Page 9 of 25

IRB-16-00761
Amendment
8. Subjects - Populations
Inclusion Criteria
Inclusion criteria include nulliparous women (no prior deliveries) at > or equal to 37 weeks gestation, with a non-
anomalous, singleton fetus in a vertex presentation.
Exclusion Criteria
 Exclusion criteria include multiparity, history of prior uterine surgery such as cesarean section or myomectomy,
 multifetal gestation, unexplained vaginal bleeding, latex allergy, or contraindication to vaginal delivery (i.e. placenta
 previa, vasa previa, active vaginal bleeding, macrosomia etc).
Enrollment Restrictions Based
 Upon Gender, Pregnancy,
 Childbearing Potential, or Race
Yes
Justify Restriction(s)
This is a study of laboring patients and therefore will be restricted only to pregnant patients.
Age Range(s)
18 to 64 Years
Targeted Population(s)
Adults - Patients , Pregnant Women
Other Aspects that Could Increase Subjects Vulnerability
The risks to subjects are inherent to the labor process itself outside of the study. The only difference in care is the use
 of a dental support device during the second stage. This may potentially shorten the duration of active pushing and
 perhaps reduce the number of cesarean sections performed for arrest of descent. There is no inherent risk to using
 the device in labor as has been evidenced by previous studies ([1] Aviram et al., [2] Matsuo et al.)
The patients in our study are all laboring nulliparous women in the second stage of labor.  All women in this study
 will have access to labor analgesia as requested by the patient.  In addition, enrollment in this study will not alter the
 current strategies regarding labor analgesia or induction protocols.
1. Aviram, A., et al., The effect of intrapartum dental support use among nulliparous during the second stage of labor
 - a randomized controlled study. J Matern Fetal Neonatal Med, 2016. 29(6): p. 868-71.
2. Matsuo, K., et al., Duration of the second stage of labor while wearing a dental support device: a pilot study. J
 Obstet Gynaecol Res, 2009. 35(4): p. 672-8.
Safeguards to protect Subjects rights and welfare
There is always the risk of loss of confidentiality; however, there are procedures in place to minimize this risk. To
 ensure confidentiality, the following system will be adhered to: When subjects are enrolled in this study, they will
 be assigned a unique identification code.  Corresponding medical record numbers for each code (keycode) will be
 stored in a password locked document on the MFM server that can be accessed only by members of the research
 team. At the conclusion of the data extraction, the outcome variable will be assessed and the key codes to the
 medical record numbers will no longer be necessary and that information will be permanently erased from the
 keycode file. Electronic data with identifiers will be encrypted according to Data Security Standards.
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9. Subjects - Participation
Duration of an Individual Subjects Participation in the Study
Duration of participation begins at time of recruitment until time of delivery. 
Duration Anticipated to Enroll All Study Subjects
We expect to recruit all patients within 6 months
Estimated Date for the Investigators
 to Complete This Study
Within one year
Procedures for Subjects to Request Withdrawal
 A patient may request to withdraw from the study at any time by notifying their obstetric provider.
Procedures for Investigator to Withdraw Subjects
There are no anticipated circumstances under which subjects will be withdrawn from the research without their
 consent.
Participants Will Be Recruited
Yes
Recruitment Method(s)
Clinical Practice, Other
Specify Other Recruitment Method
Eligible participants will be asked by their provider if they are interested in learning about a study aimed at decreasing
 the duration of the second stage of labor. Subjects who are interested will meet with study personnel. All aspects
 of the study will be explained. Those subjects who are interested will undergo the informed consent process. After
 informed consent, patients will be randomly assigned to one of the 2 arms of the study; to use of a dental support
 device in the second stage (intervention arm) or labor without a dental support device (control group). 
How Participants Will Be Identified
Participants will be identified after they are admitted to labor and delivery. If the patient is expected to delivery
 vaginally (i.e. the patient does not intend to delivery by cesarean section), the admitting provider will ask the patient
 if they are interested in learning more about our study. This conversation will occur immediately at the time of
 admission. The patient will then be approached by the consenting research team. Patients will be given a unique
 study ID for identification purposes.
Who Will Initially Approach
 Potential Participants
Treating Physician
How Research Will Be Introduced to Participants
Eligible participants will be asked by their provider if they are interested in learning about a study aimed at decreasing
 the duration of the second stage of labor. Subjects who are interested will meet with study personnel. All aspects
 of the study will be explained. Those subjects who are interested will undergo the informed consent process. After
 informed consent, patients will be randomly assigned to one of the 2 arms of the study; to use of a dental support
 device in the second stage (intervention arm) or labor without a dental support device (control group). 
How Participants Will Be Screened
All research-related discussions will be held in the patient's private room. Any questions will be answered and
 fully discussed to maximize patient comfort.  If they meet eligibility criteria and chose to participate they will be
 randomized and receive care within the accepted standards. 
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10. Subjects - Pregnant Women
Preclinical Studies Including Those
 on Pregnant Animals and Clinical
 Studies Including Those on Non-
Pregnant Women Have Been
 Conducted
Yes
Data for Assessing Potential Risks to Pregnant Women and Fetuses
Previous studies have identified no inherent risk in using a dental support device in labor. ([1] Aviram et al., [2]
 Matsuo et al.)
1. Aviram, A., et al., The effect of intrapartum dental support use among nulliparous during the second stage of labor
 - a randomized controlled study. J Matern Fetal Neonatal Med, 2016. 29(6): p. 868-71.
2. Matsuo, K., et al., Duration of the second stage of labor while wearing a dental support device: a pilot study. J
 Obstet Gynaecol Res, 2009. 35(4): p. 672-8.
 PI must attest that all of the following are true. 
* No inducements, monetary or otherwise, will be offered to terminate a pregnancy.
* Individuals engaged in the research will have no part in any decisions as to the timing,
 method, or procedures used to terminate a pregnancy. 
* Individuals engaged in the research will have no part in determining the viability of a
 neonate. 
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11. Procedures - Narrative
Description of the Study Design
This study is considering how the use of a dental support device may reduce the overall time to vaginal delivery in the
 second stage of labor. We will also assess other maternal and neonatal outcomes including rate of cesarean section,
 risk of infection (i.e. chorioamnionitis), bleeding, uterine atony, cesarean delivery and use of regional analgesia.
Description of Procedures Being Performed
At the time of randomization, patients in the intervention group will receive a new dental support device. The device
 is similar in appearance to a traditional athletic mouth guard but is designed to be comfortable and much less bulky.
 It is made of durable BPA free cushioned material which is easily placed in the mouth and fits between the patient's
 molars with a connecting bridge that fits in front of the patient's incisors. Patients will be asked to wear the device
 while pushing in the second stage and will be directly observed during the second stage by either the labor nurse
 or physician who is in the room. In between pushes the patient may either remove the device or leave it in place.
 We believe there is minimal risk associated with the use of a dental support device in the second stage of labor. 
 Use of such a device has been well described in the Obstetric literature as safe with minimal risks. ([1] Aviram et al.,
 [2] Matsuo et al.) Patients randomized to the control group will not receive a Laboraide device and will push in the
 second stage of labor without the use of a dental support device.
1. Aviram, A., et al., The effect of intrapartum dental support use among nulliparous during the second stage of labor
 - a randomized controlled study. J Matern Fetal Neonatal Med, 2016. 29(6): p. 868-71.
2. Matsuo, K., et al., Duration of the second stage of labor while wearing a dental support device: a pilot study. J
 Obstet Gynaecol Res, 2009. 35(4): p. 672-8.
Description of the Source Records that Will Be Used to Collect Data About Subjects 
Data will be collected from documentation in the electronic medical record (EPIC).
Providers (either nurse or physician) caring for the patient in the second stage of labor will also be given a Second
 Stage Data Collection Sheet to be completed immediately after delivery in order to ensure accurate documentation
 of full dilation and time spent pushing in labor.
Finally, data will be collected from surveys that are completed after delivery by patients who are randomized to use a
 device.
Description of Data that Will Be Collected Including Long-Term Follow-Up
Data collected will include demographic variables such as age, parity, BMI, , as well as gestational age, bishop
 score, indication for induction, mode of delivery, time to full dilation, time to delivery, epidural use, and length of
 ruptured membranes. Neonatal outcomes including birthweight, apgars, NICU admissions will be assessed, as well
 as maternal outcomes including EBL, chorioamnionitis, and tachysystole.
Data will be analyzed on an intention to treat basis. Statistical analysis will be performed by SAS using X 2 test or
 Fisher exact test (categorical variables) and student t-test or Mann-Whitney U test (continuous variables). Statistical
 significance will be set at p<0.05. 
Research Requires HIV Testing
No
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12. Procedures - Genetic Testing
Genetic Testing Will Be Performed
No
Guidance and Policies > Future Use Data Sharing and Genetic Research
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13. Procedures - Details
Surveys or Interviews
No
Audio / Photo / Video Recording
No
Deception
No
Results of the Study Will Be Shared
 with Subjects or Others
No
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14. Procedures - Compensation
Compensation for Participation
No
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15. Consent - Obtaining Consent
Consent Process
Adult Consent
Where and When Consent Will Be Obtained
All research-related discussions will be held in the patient's private room. Any questions will be answered and fully
 discussed to maximize patient comfort.  If they chose to participate they will be randomized and receive care within
 the accepted standards. 
Waiting Period for Obtaining Consent
The consent process will take place after admission to the labor floor and before the onset of the second stage of
 labor. It is not feasible to consent patients prior to the onset of labor as the majority of patients who deliver at Mount
 Sinai receive their prenatal care in locations a various private offices in New York City. Their first presentation to the
 Mount Sinai labor floor is generally either for a planned induction of labor or because they are already experiencing
 contractions in the early/first stage of labor.
SOP HRP-090 Informed Consent
 Process for Research Is Being
 Used
Yes
PPHS Worksheets, Checklists and SOPs
Process to Document Consent in
 Writing
Will Use Standard Template
Non-English Speaking Participants
 Will Be Enrolled
No
Justification for Not Enrolling Non-English Speaking Participants
The patient will be consented after admission to the labor floor and informed consent will be obtained in the patient's
 private room. All study participants must be English speaking. Due to limited funding for individual fellow projects,
 the majority of available resources will be directed to acquiring devices for our study and we will not have the
 resources to translate the consent into other languages. Furthermore, the Laboraide device only supplies product
 documentation in English and Hebrew. We will be following SOP HRP-090 Informed Consent Process for Research.
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16. Consent - Documents
Consent Documents
Type
502a Consent
Name
502_a Consent
Upload
CONSENT_502a_10_24_17.doc
Consent Templates
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17. Data - Collection
Health Related Information Will Be
 Viewed, Recorded, or Generated
Yes
Description of Health Information That Will Be Viewed, Recorded, or Generated
Data collected from the electronic medical record will include demographic variables such as age, parity, BMI, as
 well as gestational age, bishop score, indication for induction, mode of delivery, time to full dilation, time to delivery,
 epidural use, and length of ruptured membranes. Neonatal outcomes including birthweight, apgar scores, NICU
 admissions will be assessed, as well as maternal outcomes including estimated blood loss, chorioamnionitis, and
 tachysystole.
Non-Health Related Information Will
 Be Viewed or Recorded
No
HIV / AIDS Related Information Will
 Be Viewed or Recorded
No
Data That Will Be Viewed,
 Recorded, or Generated Contains
 ANY of the Following Directly
 Identifiable Information
No
  
  * Name 
  * Social Security Number 
  * Medical Record Number 
  * Address by Street Location 
  * Telephone Number 
  * Fax Number 
  * Web Uniform Resource Locators (URLs) 
  * Internet Protocol (IP) Address 
  * Health Plan Beneficiary Number 
  * Account Number 
  * Certificate 
  * License Number 
  * Vehicle Identification Number (Including License Plate Numbers) 
  * Full-Face Photographic Images 
  * Biometric Identifiers (Finger and Voice Prints) 
  * Geographical Subdivisions Smaller Than a State 
  * All Elements of Dates for Dates Directly Related to an Individual (i.e., Birth Date,
 Admission Date, Discharge Date) 
     * Email Address 
     
 
Data Collection Sheet
Data Collection Sheet.docx
        
        A Data Collection Sheet is required if you are either performing a retrospective review,
 or your study meets the category of exempt 4 research, or your study meets the category
 of expedited 5 research. Please upload it here.
        
    
Data Collection Source(s)
Participant, Medical Chart (Paper or
 Electronic)

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18. Data - Storage
Location Where Data Will Be Stored
Each patient will be assigned a unique identification code. The code will be linked to the name and date of birth in
 an encrypted password-protected linking key code file which will be stored on the PI's personal network folder in the
 Hospital IT server, accessible by the PI only. The data will be stored in a separate password-protected database by
 the unique identification code. The database will be stored on a secure desktop at Mount Sinai hospital (5 E 98th
 St, Second Floor, Room 249, Department of OB/GYN, New York, NY 10029) and accessible only to members of the
 research team.  
Identifiable patient information (consent forms & consent documentation) are kept separately from any data collected.
 All physical data is stored in a locked cabinet in our department (5 E 98th St, Second Floor, Room 249, Department
 of OB/GYN, New York, NY 10029). 
How will the data be stored?
With a Code That Can Be Linked to the
 Identity of the Participant
Research Personnel Responsible
 for:
Angela Bianco
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Yes
Research Personnel Responsible
 for:
Eric Bergh
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Luciana Vieira
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Katherine Connolly
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Stephanie Factor
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Joanne Stone
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No

Research Personnel Responsible
 for:
Brittany Noel Robles
Accessing Data
No
Receipt or Transmission of Data
No
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Catherine Bigelow
Accessing Data
No
Receipt or Transmission of Data
No
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Patricia Rekawek
Accessing Data
No
Receipt or Transmission of Data
No
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Amrin Khander
Accessing Data
No
Receipt or Transmission of Data
No
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Jessica Spiegelman
Accessing Data
No
Receipt or Transmission of Data
No
Holding Code That Can Be Linked
 to Identity of Participants
No
Duration Data Will Be Stored
Final data analysis and publication is anticipated in the fall of 2017. Data will be destroyed following publication.
Steps That Will Be Taken to Secure the Data During Storage, Use, and Transmission
Each patient will be assigned a unique identification code. The code will be linked to the name and date of birth in
 an encrypted password-protected linking key code file which will be stored on the PI's personal network folder in the
 Hospital IT server, accessible by the PI only. The data will be encrypted and will be stored in a separate password-
protected database by the unique identification code. The encrypted database will be stored on a secure desktop at
 Mount Sinai hospital and accessible only to members of the research team.  
Identifiable patient information (consent forms & consent documentation) are kept separately from any data collected.
 All physical data is stored in a locked cabinet in our department. 
Data Analysis Plan Including Any Statistical Procedures
Data will be analyzed on an intention to treat basis. Statistical analysis will be performed by SAS using chi-square
 test or Fisher exact test (categorical variables) and student t test or Mann-Whitney U test (continuous variables).
 Statistical significance will be set at p<0.05. 
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19. Data - Safety Monitoring
More Than the Minimum Data
 Safety Monitoring Will Be Done
No
  
  The following minimum requirements apply to all projects, including retrospective
 reviews of medical records, use of tissue samples, and many minimal risk studies, such
 as observational and survey research. Because these minimum requirements apply to
 all studies, a specific written DSMP will not usually be required for projects that do not
 pose greater than minimal risk to subjects. The MSSM PPHS may alter the required level of
 monitoring if appropriate. 
  For all projects, the principal investigator must have a plan to assure that data integrity
 will be maintained during its collection, storage and analysis. All research projects
 must adhere to MSSM recommendations on the storage of research data. Loss of data
 containing identifiable information is reportable to the IRB within 5 business days.
  Any problems concerning the consent process and any subject complaints should be
 monitored by the investigator. Reports of such problems must be made at least annually.
 The discretion of the protocol director will guide the need to report these problems
 immediately or more frequently.
  The principal investigator is, typically, the monitoring entity for the minimum DSMP. When
 a principal investigator is not a faculty member, the supervising faculty member must be
 responsible for the data and safety monitoring aspect of the protocol.
     
 
Will the Research Include Data
 Coordinating Center Activities?
No
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20. Financial Administration
  This information will help the Financial Administration of Clinical Trials Services (FACTS)
 office determine whether a Medicare Coverage Analysis (MCA) is needed for the research
 study. If you have any questions while completing this form, please contact the FACTS
 office at (212) 731-7067 or FACTS@mssm.edu.
Clinical Research Study Category
Investigator Initiated
 Payment Options: 
* Option 1:  No protocol-required services will be billed to patients or third-party payers.
 Does Not Need MCA 
* Option 2:  Protocol-required services (i.e., routine care services) will be billed to patients
 or third-party payers. Must Have MCA 
* Option 3:  Study is initiated and federally funded by a Government Sponsored
 Cooperative Group who will only pay for services that are solely conducted for research
 purposes and other protocol-required services (i.e., routine care services) will be billed to
 patients or third-party payers. Billing Grid Only Required, NO MCA 
* Option 4:  Study involves only data collection and has no protocol-required clinical
 services. Does Not Need MCA 
* Option 5:  Study is not described in any of the above options. Please describe the study
 and specify whether External Sponsor (i.e., industry, government, or philanthropic source)
 and/or patient/third party payer will pay for protocol required services. MCA MAY Be
 Required 
Payment Option
Option 1
 No MCA is needed per option selected above. 
 Payment Option 1: 
* Option 1A:  Department/collaborating departments will act as internal sponsor paying for
 all protocol-required services and no protocol-required services will be billed to patients or
 third party payers. 
* Option 1B:  Study involves protocol-required clinical services and an External Sponsor
 (i.e., industry, government, or philanthropic source) will pay for all protocol-required
 services. 
Payment Option 1
Option 1A
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21. Attachments
Type
Name
Version Status
Filename
Uploaded
 Date
Consent Documents
CONSENT_502a_10_24_17.doc
1
New
CONSENT_502a_10_24_17.doc
10/25/2017
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