Clinical trial NCT03106753
Conditions: External Cephalic Version
Keywords: External Cephalic Version neuraxial analgesia
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2017-04-12; Completion date: 2018-05-05
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the best way to optimize the success of external cephalic version (turning the baby from the outside). Attempting to turn babies in-utero is recommended because it may decrease the risk of needing a cesarean section for abnormal presentation. While the study team knows that this procedure can be effective, the study team still has some un-answered questions as to the best way to perform this procedure to increase the chance of success. Many prior studies have shown that using spinal anesthesia (a shot of medication placed in your back to numb and relax the abdomen) can increase the success rate of a version. This ultimately has led to the finding that using this anesthesia can decrease the rate of cesarean section. However, there have been only a small number of studies assessing the success rate if spinal anesthesia is used only in the event that without it fails. Therefore the study team is going to compare patients who receive spinal anesthesia with those who only receive spinal anesthesia if the procedure to turn the baby (ECV) fails without it.

Detailed description:
Breech presentation occurs in approximately 3-4% of term pregnancies and leads to one of the most common indications for cesarean delivery. Attempting an external cephalic version (ECV) significantly increases the chance of cephalic presentation at time of delivery and reduces the chance of cesarean section. Since ECV does in fact reduce the rate of cesarean section, many studies have sought to determine the best method to perform the procedure to optimize the chance of success. A recent meta-analysis concluded that administration of neuraxial analgesia significantly increases the success rate of ECV and also increases the incidence of vaginal delivery. However, there have been only 2 prospective studies and no randomized trials that evaluated the success of ECV using neuraxial analgesia only when initial attempt without it has failed. Therefore, the study team designed a randomized controlled trial with two groups: Group 1- patients receiving spinal anesthesia immediately versus Group 2- patients attempting ECV without spinal anesthesia with reattempt using a spinal if first attempt fails. This study will be conducted on labor and delivery at Mount Sinai West hospital. Patients who present to labor and delivery at term for ECV will be approached for enrollment and those who consent to be part of the study would be randomized into a group. ECV will then be attempted and delivery and neonatal outcomes will be collected. Patients will likely be enrolled in the study from time of version (approximately 37 weeks) until postpartum. This study will take approximately 1-2 years given the ECV rate.

Arms: arm 1: The patient will have a spinal administered by the on call anesthesiologist using standard protocol (intrathecal bupivacaine 7.5 mg). The patient will then be administered 0.25 mg Terbutaline subcutaneously and the ECV will be attempted. Under ultrasound guidance the provider will attempt to lift the breech upward from the pelvis with one hand and guide the head with the other hand to produce a forward roll. If forward roll fails, a backward roll somersault may be attempted. ECV attempt will be abandoned if there is significant fetal bradycardia, discomfort to the patient, or if the procedure cannot be completed easily with these maneuvers. Once attempt is complete, whether successful or not, the patient will be monitored for a minimum of 30 minutes, and will be discharged once they are able to walk, void, and tolerate PO intake, only if fetal and maternal status is reassuring. arm 2: The patient will be administered terbutaline 0.25 mg subcutaneously and the version will be attempted using the same procedure as above. If successful, the patient will be monitored for 30 minutes and discharged if fetal and maternal status is reassuring. If the attempt fails, the patient will be administered spinal anesthesia as above and the same maneuvers will be attempted. Once attempt is complete, whether successful or not, the patient will be monitored for a minimum of 30 minutes, and will be discharged once they are able to walk, void, and tolerate PO intake, only if fetal and maternal status is reassuring.
Interventions: intervention 1: Bupivacaine intervention 2: Terbutaline
Intervention descriptions: intervention 1: intrathecal bupivacaine 7.5 mg intervention 2: 0.25 mg Terbutaline subcutaneously

Protocol documents:
Prot_SAP_000.pdf: 
Success of External Cephalic Version With Immediate Spinal Anesthesia Versus 
Spinal Anesthesia When Attempt
Without Anesthesia Has Failed: A Randomized Controlled Trial.
PI: Natalie Porat
NCT03106753
Document Date: Dec 21, 2016


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IRB-17-01230
Initial Application
Natalie Porat
1. Summary - Title
Protocol Title
Success of External Cephalic Version With Immediate Spinal Anesthesia Versus Spinal Anesthesia When Attempt
 Without Anesthesia Has Failed: A Randomized Controlled Trial.
Principal Investigator
Natalie Porat
Primary Department
Obstetrics/Gynecology
Application Initiated By
Natalie Porat
Lay Summary
This is a randomized controlled trial assessing the success of external cephalic version (ECV).  When patients are
 noted to be in breech presentation (bottom of baby facing down) at  37 weeks gestation they are encouraged to
 undergo an ECV procedure (an external rotation done by the obstetrician) which rotates the baby to a cephalic
 presentation (head facing down) in order to allow for vaginal delivery.  Patients who fail this procedure undergo a
 cesarean section if the baby has still not rotated by the time of delivery.  At our institution, this is usually done by
 giving a tocolytic (relaxant to the uterus) and performing the procedure.  In rare cases the patient may be offered
 spinal anesthesia, particularly when the attempt was unsuccessful without anesthesia and the provider believes
 that anesthesia will facilitate success or if the patient is not tolerating  the procedure due to pain.  Randomized
 control studies and a recent meta-analysis have suggested that spinal anesthesia increases the success rate of
 ECV significantly and decreases the number of cesarean sections.  However, there have been limited studies on
 using spinal anesthesia only if the procedure fails without it.    Our study aims to randomize patients who present
 for ECV into two groups.  Group 1: patients who receive spinal anesthesia immediately and Group 2: patients who
 receive spinal anesthesia only if the procedure first fails without it.  Comparing these two groups is essential in order
 to optimize ECV procedure protocols with the highest success and least invasive approach.
IF Number
IF1989320
Page 1 of 25


IRB-17-01230
Initial Application
Natalie Porat
2. 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 Research that Requires
 Approval from the Protocol Review
 and Monitoring Committee (PRMC)
No
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   
Radiological Procedures
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 2 of 25


IRB-17-01230
Initial Application
Natalie Porat
3. Summary - Background
Objectives
To test the hypothesis that patients undergoing ECV with spinal anesthesia will have the same rate of success as
 those undergoing the procedure without anesthesia initially with reattempting using spinal if unsuccessful.
Background
Breech presentation occurs in approximately 3-4% of term pregnancies and leads to one of the most common
 indications for cesarean delivery.  Attempting an external cephalic version (ECV) significantly increases the chance
 of cephalic presentation at time of delivery and reduces the chance of cesarean section(1).  Since ECV does in
 fact reduce the rate of cesarean section, many studies have sought to determine the best method to perform the
 procedure to optimize the chance of success.  A recent meta-analysis concluded that administration of neuraxial
 analgesia significantly increases the success rate of ECV and also increases the incidence of vaginal delivery(2). 
 However, there have been only 2 prospective studies and no randomized trials that evaluated the success of ECV
 using neuraxial analgesia only when initial attempt without it has failed(3,4).  Therefore, we would like to design
 a randomized controlled trial with two groups: Group 1- patients receiving spinal anesthesia immediately versus
 Group 2- patients attempting ECV without spinal anesthesia with reattempt using a spinal if first attempt fails. 
 This study would be conducted on labor and delivery at Mount Sinai West hospital.  Patients who present to labor
 and delivery at term for ECV would be approached for enrollment and those who consent to be part of the study
 would be randomized into a group.   ECV would then be attempted and delivery and neonatal outcomes would be
 collected.  Patients would likely be enrolled in the study from time of version (appox 37 weeks) until postpartum. 
 This study will take approximately 1-2 years given our ECV rate.  References: 1.  Hofmeyr GJ, Kulier R, West HM.
 External cephalic version for breech presentation at term. Cochrane Database of Syst Rev2015;4: CD000083. 2. 
 Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success
 rate of external cephalic version: a systematic review and metaanalysis of randomized controlled trials. Am J Obstet
 Gynecol 2016;215:276-86. 3.  Neiger R, Hennessy MD, Patel M.  Reattempting external cephalic version under
 epidural anesthesia.  Am J Obstet Gynecol 1998;179:1136-9. 4.  Rozenberg P, Goffinet F, de Spirlet M, Durand-
Zaleski I, Blanie P, Fisher C, Lang AC, Nisand I: External cephalic version with epidural anaesthesia after failure of a
 first trial with beta-mimetics. BJOG 2000; 107:406-10. 
Primary and Secondary Study Endpoints
The primary outcome will be the success rate of external cephalic version to cephalic presentation.  Secondary
 outcomes will include: time from procedure to delivery, mode of delivery, patient discomfort, adverse events during
 procedure (ie.fetal bradycardia, emergent cesarean section, abruption), neonatal outcomes (ie. birthweight, Apgars,
 cord pH, NICU admission).  The external cephalic version procedure may be terminated in any patient at any time
 regardless of this study in the event of persistent fetal heart rate abnormalities, maternal request, or any other
 adverse findings that the physician believes is an indication that the procedure must be terminated.
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 3 of 25


IRB-17-01230
Initial Application
Natalie Porat
4. Research Personnel
Name/Department
Role/Status
Contact
Access
Signature
 Authority
Phone
Email
Natalie Porat /
 Obstetrics/
Gynecology
PI / 
Yes
SIGNAUTH
Lois Brustman /
 Obstetrics/
Gynecology
Co-Investigator / 
EDIT
Barak Rosenn /
 Obstetrics/
Gynecology
Co-Investigator / 
EDIT
Zainab Al-Ibraheemi /
 Obstetrics/
Gynecology
Co-Investigator / 
EDIT
Dyese Taylor /
 Obstetrics/
Gynecology
Co-Investigator / 
EDIT
Migdalia Saloum /
 Anesthesiology
Co-Investigator / 
EDIT
Julio Marenco /
 Anesthesiology
Co-Investigator / 
EDIT
Jason White /
 Anesthesiology
Co-Investigator / 
EDIT
 
Page 4 of 25


IRB-17-01230
Initial Application
Natalie Porat
5. Sites
Site Name
Mount Sinai West
Other External Site Name
Contact Details
Approved
0
Approval Document
Funded By Mount Sinai
1
Reviewed By
Mount Sinai IRB
Other IRB
Page 5 of 25


IRB-17-01230
Initial Application
Natalie Porat
6. Subjects - Enrollment
Site Name
Mount Sinai Roosevelt
Subjects To Be Enrolled
100
Total
100
Page 6 of 25


IRB-17-01230
Initial Application
Natalie Porat
7. Subjects - Setting and Resources
Setting of Human Research
Other
Specify Other Setting of Human Research
Labor and Delivery unit at Mount Sinai West hospital.
Total Number of Subjects Needed
 To Complete Study
100
Feasibility of Meeting Recruitment Goals
From 2012-present we have attempted approximately 89-115 external cephalic versions a year.  Each year we have
 been increasing in numbers, with 115 patients in 2015.  These numbers only include patients who had an attempted
 ECV and does not include patients that were scheduled for ECV but the procedure was not performed for various
 circumstances.  Given this information we believe that it will take approximately 1-2 years to recruit 100 patients.  
Facilities To Be Used for Conducting Research
We will be conducting our research on labor and delivery and the MFM fellow office located in Mount Sinai West
 Hospital, suite 10-C.
Multi-Center Study
No
Community-Based Participant
 Research Study
No
  PI must attest to the following.    * Process is adequately described to ensure that
 all persons assisting with the trial are adequately informed about the protocol, the
 investigational product(s), and their trial-related duties and functions.         
Page 7 of 25


IRB-17-01230
Initial Application
Natalie Porat
8. Subjects - Populations
Inclusion Criteria
Singleton pregnancies of at least 37 weeks gestation in nonvertex presentation with no contraindication for a vaginal
 delivery.  Membranes must be intact with a minimum of a 2x2 pocket and Category 1 non-stress test.
Exclusion Criteria
All patients with a contraindication for a vaginal delivery will be excluded from the study, as well as those patients
 with gross fetal anomalies or uterine malformations.  Patients with contraindications to neuraxial anesthesia or
 allergies to any of the study medications will also be excluded.
Enrollment Restrictions Based
 Upon Gender, Pregnancy,
 Childbearing Potential, or Race
Yes
Justify Restriction(s)
Patient must be pregnant in order to enroll because this is a study involving fetal versions.
Age Range(s)
18 to 64 Years
Targeted Population(s)
Adults - Patients , Pregnant Women
Other Aspects that Could Increase Subjects Vulnerability
There are no further aspects that could increase the subjects vulnerability.
Safeguards to protect Subjects rights and welfare
In order to protect the subjects rights we will be consenting the patients and allowing them to decide if they would like
 to participate.  Patients will be assured that their decision to participate in the study is completely optional and that
 their care will not be altered in the event that they do not wish to participate.  Patients will be given time to decide if
 they would like to participate and all questions will be answered.  
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9. Subjects - Participation
Duration of an Individual Subjects Participation in the Study
The individual subject will be participating in the study for approximately 1-8 hours depending on how long the
 procedure takes.  We will then follow-up their delivery information using labor and deliveries' EMR (Peribirth).  The
 patient will not be contacted at this time.  Once delivered they will no longer be part of the study.  Delivery usually
 occurs within 5 weeks of the procedure given that the procedure is only done at 37 weeks or higher.
Duration Anticipated to Enroll All Study Subjects
We will be enrolling study subjects for 2 years.
Estimated Date for the Investigators
 to Complete This Study
Within two years
Procedures for Subjects to Request Withdrawal
Patients can withdraw at anytime and will be aware of that option.  We will be conducting an intention-to-treat
 analysis.  If the patient decides to withdraw we will then ask the patient if we can still collect their demographic and
 delivery data.  If they allow this, then they will be included in the analysis and this will be stated in our results once
 the study is written.  No identifiers will be included in the results.  If they would like to withdraw completely we will not
 collect any further data and we will not include them in our analysis.
Procedures for Investigator to Withdraw Subjects
There is no circumstance that the patient will be withdrawn without their consent.  There is no anticipated reason that
 a patient would need to be terminated from the study.  If there is any concern that there is risk to the fetus during
 the procedure, the procedure will be terminated and the patient will still be included in the study.  This will then be
 discussed and explained in our study results.
Participants Will Be Recruited
Yes
Recruitment Method(s)
Clinical Practice
How Participants Will Be Identified
Each day external cephalic versions are scheduled on labor and delivery.  When a patient is noted to be scheduled
 for a version, once they are admitted and there is no contraindication noted for the participation in the study (for
 example, they come for a version but are found to be in the cephalic presentation that day) they will be asked if they
 are willing to participate in a study.  If the patient agrees, a member of the research team will approach the patient
 and discuss the study with the patient.
Who Will Initially Approach
 Potential Participants
Study Personnel
How Research Will Be Introduced to Participants
Once they are admitted for a version and there are no contraindications for the procedure, the patient will be asked if
 they are willing to participate in a study.  If so, a member of the research team will approach the patient.  In a private
 setting, they will be introduced to the study and will be given as long as they need to decide whether they would
 like to participate in the study.  Since the patient will be receiving IV hydration prior to the procedure (whether or not
 they are going to be part of the study), they will be given as long as it takes for the IV fluids to run.  This is usually
 between 30 minutes to an hour.  If they need more time to decide, they will be given additional time as needed.
How Participants Will Be Screened
Participants will be screened by looking at the scheduling book each day.  
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10. Subjects - Risk and Benefits
Risks to Subjects
Overall, there is a minimal risk to subjects who participate in this study.  In terms of the procedure itself, there
 have been adverse events reported after ECV including placental abruption, umbilical cord prolapse, rupture of
 membranes, stillbirth and fetomaternal hemorrhage.  These adverse events are rare, occurring in less then 1% and
 thus the American College of Obstetrics and Gynecology (ACOG) does endorse attempting ECV when possible in
 centers where prompt evaluation and, if necessary, cesarean delivery is readily available.  In regards to neuraxial
 analgesia, Magro-Malosso et. al, recently performed a metal analysis comparing use of neuraxial analgesia versus
 controls during ECV attempts and found no difference in adverse outcomes between groups (emergency cesarean
 delivery, transient bradycardia, nonreassuring fetal testing, or placental abruption).  It does appear that patients who
 do not receive neuraxial analgesia do experience more discomfort during the procedure.  
Description of Procedures Taken to Lessen the Probability or Magnitude of Risks 
In order to lessen the magnitude of risks, patients will be monitored for at least 30 minutes post procedure as
 recommended by ACOG, or longer if fetal testing is non-reassuring.  In addition, procedure attempts will be
 terminated if the provider believes there is risk to the fetus at any time.  This procedure is also done under
 ultrasound guidance to monitor the fetus throughout.  Lastly, patients will be given strict post procedure precautions
 for when they are discharged from the hospital.
Provisions for Research Related Harm / Injury
There is no anticipated research related harm for study subjects.  There is a very small risk of adverse outcomes
 inherent in the procedures themselves, but this is not due to participating in research.  Medical personal will be
 readily available for any adverse outcome as is standard for all pregnant patients in such events.
Expected Direct Benefit to Subjects
Each subject may be expected to directly benefit from participation in this study.  For those that are in the immediate
 spinal group, these patients may benefit from less discomfort (as is noted in prior studies) and an increased external
 cephalic version success rate (compared to controls).  Those who are in the spinal anesthesia only if ECV fails
 without it, may benefit from not having to undergo an additional procedure (neuraxial anesthesia) when attempt
 leads to cephalic presentation with ease.  It is unclear if these patients will have the same ECV success rate, but
 prior non-randomized trials do suggest this finding.
Benefit to Society
The results of this study may benefit society in that a better protocol may be in place for ECV attempts that increases
 the rates of success without increasing the rate of risk or cost.
Provisions to Protect the Privacy Interests of Subjects
The patients will be approached by the a member of the study team on the labor floor to determine if they are
 willing to be included in the study. Their participation will not require any additional examinations. They will only be
 approached once by the study team on the labor floor to determine if they are willing to participate. 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.  Patients will be allowed time to consider participation and we will explain to patients that
 we will follow up their delivery information, but will not contact them directly.  We will also assure the patient all the
 steps that will be taken to protect their privacy.
Economic Impact on Subjects
We do not see any foreseeable additional costs to subjects for participating in this research study.  The patient is
 already in the hospital to undergo a version and anesthesia may or may not be used for this procedure even when
 not participating in the study.
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11. Subjects - Pregnant Women
Preclinical Studies Including Those
 on Pregnant Animals and Clinical
 Studies Including Those on Non-
Pregnant Women Have Been
 Conducted
No
Data for Assessing Potential Risks to Pregnant Women and Fetuses
There have been many studies on pregnant women undergoing external cephalic versions.  These studies have
 concluded that attempting ECV is beneficial, and use of neuraxial anesthesia  also increases success rates
 and decreases cesarean section rates.  They have also found no increased rate of adverse outcomes.    Since
 this procedure is only performed in the third trimester no inducements, monetary or otherwise, will be offered to
 terminate a pregnancy.  Individuals engaged in the research team will have no part in any decisions as to 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.
  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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12. Procedures - Narrative
Description of the Study Design
This is a randomized controlled trial comparing two groups.  Patients will be admitted to labor and delivery for
 external cephalic version.  They will be approached by a member of the research team if they are eligible to
 participate.  If they choose to consent, they will be randomized into Group 1 or Group 2.  Patients will then undergo
 the procedure as described below.  
Description of Procedures Being Performed
There are two procedures possibly being performed.  In terms of the ECV, all patients will undergo an ultrasound
 examination as is necessary to confirm the malpresentation of the fetus and rule out any anomalies that would
 complicate a vaginal delivery.  If found to have malpresentation patients will be placed on a fetal monitor and
 isotonic solution will be administered via IV.  A CBC and type and screen will be drawn and sent.  The patient will
 then be consented for the external cephalic version,as this is the procedure that the patient has come to the hospital
 for, and will be performed regardless if they participate in the study.  After this, they will be asked if they would like
 to participate in a study.  If so, a member of the research team will approach the patient and consent the patient
 for the study.    If the patient consents and is randomized to Group 1, the patient will have a spinal administered
 by the on call anesthesiologist using standard protocol (intrathecal bupivacaine 7.5 mg).  The patient will then be
 administered 0.25 mg Terbutaline subcutaneously and the ECV will be attempted.  Under ultrasound guidance the
 provider will attempt to lift the breech upward from the pelvis with one hand and guide the head with the other hand
 to produce a forward roll.  If forward roll fails, a backward roll somersault may be attempted.  ECV attempt will be
 abandoned if there is significant fetal bradycardia, discomfort to the patient, or if the procedure cannot be completed
 easily with these maneuvers.  Once attempt is complete, whether successful or not, the patient will be monitored
 for a minimum of 30 minutes, and will be discharged once they are able to walk, void, and tolerate PO intake, only
 if fetal and maternal status is reassuring.  If the patient is randomized to Group 2, the patient will be administered
 terbutaline 0.25 mg subcutaneously and the version will be attempted using the same procedure as above.  If
 successful, the patient will be monitored for 30 minutes and discharged if fetal and maternal status is reassuring.
  If the attempt fails, the patient will be administered spinal anesthesia as above and the same maneuvers will be
 attempted.  Once attempt is complete, whether successful or not, the patient will be monitored for a minimum of 30
 minutes, and will be discharged once they are able to walk, void, and tolerate PO intake, only if fetal and maternal
 status is reassuring.
Description of the Source Records that Will Be Used to Collect Data About Subjects 
In order to collect data about the procedure, a member of the research team will fill out a questionnaire at the time
 of procedure and all questionnaires will be placed in a locked cabinet in the PI's office in Mount Sinai West- Suite-
 10C.  All other data about delivery and demographics will be collected after the procedure using labor and deliveries'
 electronic medical record system (Peribirth). 
Description of Data that Will Be Collected Including Long-Term Follow-Up
Protected Health Information (PHI) will be collected and used in the study.  No PHI will be disclosed.  Only study
 personnel will have access to subject information. The study investigators will collect medical information about
 the subject over the course of the study. Study data will be entered into a de-identified research secure password-
protected database, using a unique code numbering system.  A code number linked to subject identity will be
 used instead of names.  The code number will not be derived from any patient identifiers, such as patient name or
 medical record number.  The record linking the subjects' name with their assigned codes will be kept on a password
 protected file on a secure departmental drive.  Only the PI will have access to this file.  All study forms will be kept
 private and stored in a locked file cabinet in a secure location in the office of the PI.    The secure computerized
 research database will be on a password-protected file within the OB/GYN department at Mount Sinai West.  The
 linked code and dates of service are the only patient identifiers to be collected onto the computerized database
 spreadsheet along with the subject's medical information needed for the purposes of the study.  Once data collection
 and analysis is completed, the linked code and data will be deleted. 
Research Requires HIV Testing
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13. Procedures - Genetic Testing
Genetic Testing Will Be Performed
No
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14. Procedures - Details
Surveys or Interviews
Yes
Type of Instruments Being Used
Created By Research Team
Description of Instruments Created By Research Team
The research team has created a questionnaire that will be filled out by the person performing the procedure once
 the procedure is completed.  This questionnaire will then be collected by the PI and stored in a locked cabinet in the
 PI's office. 
Audio / Photo / Video Recording
No
Deception
No
Results of the Study Will Be Shared
 with Subjects or Others
No
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15. Procedures - Instruments
Instruments Created By Research Team
Type
Questionnaire
Name
Questionnaire
Upload
Study form.docx
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16. Procedures - Compensation
Compensation for Participation
No
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17. Consent - Obtaining Consent
Consent Process
Adult Consent
Where and When Consent Will Be Obtained
External cephalic versions are scheduled each day by the patients' primary obstetrician.  If a patient is found to be
 eligible for the study, an investigator will approach the patient  once they are admitted for their external cephalic
 version on labor and delivery.  A member of the research team will then review the consent with them.  The
 investigator will give the potential subject the opportunity to ask any questions and have them answered.  They will
 be given the opportunity to think about the study.  (Only those investigators listed as study personnel and authorized
 to obtain consent, will obtain informed consent).  Once a patient wishes to join the study and informed consent is
 obtained, the subject can participate.  Each subject will receive a signed copy of the consent form.  The subject can
 withdraw from the study at any time without any retribution. 
Waiting Period for Obtaining Consent
The patient will be given as much time as they need to consider consenting for the study.  Each patient that is
 admitted for an external cephalic version is placed on the fetal monitor and given 1-2 liters of isotonic solution prior
 to the procedure (this is routine at our institution).  They will be given that amount of time (usually 30 minutes-1 hour)
 to decide if they would like to take part in the study.  If they need more time, then we will wait until the patient has felt
 that they have had adequate time to decide if they would like to participate.  
SOP HRP-090 Informed Consent
 Process for Research Is Being
 Used
Yes
Process to Document Consent in
 Writing
Will Use Standard Template
Non-English Speaking Participants
 Will Be Enrolled
Yes
What Languages Other Than English Will Be Used
Any language can be used as long as an approved interpreter is available for that language at the time of consent. 
 We will follow the Short Form Policy regarding proper consent and interpreters.
What Process Will Be Used
Short Form
    Attest that you will follow the Short Form Policy ([insert link]), including the Hospital
 policy (A3-105 at ISMH and HHC Administrative Policy ADM 30 at Elmhurst/Queens)
 regarding approved interpreters.      
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18. Consent - Documents
Consent Documents
Type
Consent
Name
Consent
Upload
Consent2(unmarked).doc
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19. Data - Collection
Health Related Information Will Be
 Viewed, Recorded, or Generated
Yes
Description of Health Information That Will Be Viewed, Recorded, or Generated
Primary outcome data to be collected includes: successful external cephalic version.  Other information that will be
 recorded includes: name, MR #, ultrasound findings, patient pain score (1-10) from procedure, score for ease of
 performing the procedure,  complications from procedure, delivery mode, 5 minute, Apgar score <7, arterial cord
 pH <7.2, NICU admission.  Demographic data will also be collected such as age, race, BMI, parity, and medical
 disease.
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
Yes
Will Be Viewed
Name, Medical Record Number
Will Be Recorded
Name, Medical Record Number
Data Collection Sheet
                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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20. Data - HIPAA
Obtaining HIPAA Authorization
Yes
How PHI Will Be Protected from Improper Use or Disclosure
Protected Health Information (PHI) will be collected and used in the study.  No PHI will be disclosed.  Only study
 personnel will have access to subject information. The study investigators will collect medical information about
 the subject over the course of the study. Study data will be entered into a de-identified research database, using
 a unique code numbering system.  A code number linked to subject identity will be used instead of names.  The
 code number will not be derived from any patient identifiers, such as patient name or medical record number.  The
 record linking the subjects' name with their assigned codes will be kept on a password protected file on a secure
 departmental drive.  Only the PI will have access to this file.  All study forms will be kept private and stored in a
 locked file cabinet in a secure location in the office of the PI.    The computerized research database will be on a
 password-protected file within the OB/GYN department at Mount Sinai West.  The linked code and dates of service
 are the only patient identifiers to be collected onto the computerized database spreadsheet along with the subject's
 medical information needed for the purposes of the study.  Once data collection and analysis is completed, the
 linked code and data will be deleted. 
PHI Will Be Destroyed at the
 Earliest Opportunity Consistent
 with the Research
Yes
When and How PHI Will Be Destroyed 
The files containing the data and linking files (containing PHI) will be deleted once all data has been analyzed.  This
 will likely be approximately within 1 year of study completion.
PHI Will Be Shared
No
  PI must attest to the following.  * I assure that the protected health information (PHI) will
 not be disclosed to any other person or entity not listed on this form except where required
 by law or for the authorized oversight of this research project. If at any time I want to reuse
 this PHI for other purposes or disclose it to other individuals or entities I will seek approval
 from the IRB.    
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21. Data - Storage
Location Where Data Will Be Stored
The research data file is stored on a secure "departmental" network drive and the file will be password protected.
How will the data be stored?
With a Code That Can Be Linked to the
 Identity of the Participant
Research Personnel Responsible
 for:
Natalie Porat
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
Yes
Research Personnel Responsible
 for:
Lois Brustman
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Barak Rosenn
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Zainab Al-Ibraheemi
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Dyese Taylor
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Migdalia Saloum
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Julio Marenco
Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Research Personnel Responsible
 for:
Jason White


Accessing Data
Yes
Receipt or Transmission of Data
Yes
Holding Code That Can Be Linked
 to Identity of Participants
No
Duration Data Will Be Stored
Data will be stored until the data is analyzed, within 1 year from study completion.
Steps That Will Be Taken to Secure the Data During Storage, Use, and Transmission
The study investigators will collect medical information about the subject over the course of the study. Study data will
 be entered into a de-identified research database, using a unique code numbering system. A code number linked to
 subject identity will be used instead of names. The code number will not be derived from any patient identifiers, such
 as patient name or medical record number. The record linking the subjects' name with their assigned codes will be
 kept on the computer in a separate secure folder. All files are password protected on a secure server.
Data Analysis Plan Including Any Statistical Procedures
Continuous variables will be analyzed using two tailed T-test and categorical variables will be analyzed using
 Pearson Chi Square test. Logistic regression will be used to adjust for confounders. A p-value <0.05 will be
 considered significant.
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22. 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.      
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23. 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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24. Attachments
Type
Name
Version Status
Filename
Uploaded
 Date
Instruments
Study form.docx
1
New
Study form.docx
12/21/2016
Consent Documents
ECV Consent-1.doc
1
New
Consent2(unmarked).doc
02/09/2017
 
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