Elevation of the Fetal Buttocks Prior to External Cephalic Version
Phase: NA
Conditions: Breech Presentation, External Cephalic Version
Sponsor: AdventHealth

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Study Protocol Title: 
Elevation of the Fetal Buttocks Prior to External Cephalic Version 
Study Sponsor:   
AdventHealth Orlando 
Principal Investigator: 
Principal investigator: D. Ashley Hill, MD. 
NCT04538261
IRB Approval Date: 
11/23/2021

 
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List of Abbreviations: 
ECV  
External Cephalic Version 
 
FHR  
Fetal heart rate 
 
FDA  
Food and Drug Administration 
 
VAS  
Visual Analog Scale  
 
EMR  
Electronic medical record 
 
 

 
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Introduction 
 
This document is a protocol for a human research study. This study will be conducted in 
accordance with applicable federal regulations and institutional research policies and procedures. 
 
Background Information and Scientific Rationale 
Breech presentation, where the baby’s buttocks or feet are presenting first, occurs in 3-4% of 
pregnancies after 37 weeks gestational age.1  Options for patient with a term breech baby include 
cesarean delivery, attempted vaginal breech delivery, or attempted conversion from breech to a 
head first (cephalic) presentation using a procedure called external cephalic version (ECV).  
Breech vaginal deliveries are increasingly less common due to findings from a meta-analysis and 
systematic review that a planned cesarean delivery reduced both perinatal and neonatal death.   
 
Many patients would like the opportunity to deliver vaginally, and in most cases those patients 
with a breech presentation after 36 weeks gestational age may be offered an ECV.  ECV has 
varying rates of success depending on many factors, including whether the woman has had any 
prior pregnancies, the position of the baby, the amount of amniotic fluid, and whether the buttocks 
are deeply engaged in the pelvis. 
 
Many obstetricians prefer to attempt ECV between 36-37 weeks gestational age because the 
success rate is similar to 34 weeks, but the baby is less likely to need neonatal intensive care if an 
emergent cesarean delivery is necessary.  The success rate for nulliparous patients (those who have 
never delivered before) without spinal or epidural anesthesia is approximately 30%.  
 
There are very few interventions to improve the success of ECV.  A randomized trial of nulliparous 
patients undergoing ECV with and without spinal anesthesia found a success rate of 32% without 
and 67% with anesthesia.   While this is an impressive improvement in success, many of our 
patients do not wish to have regional anesthesia.  Regional anesthesia also increases the length of 
stay and cost of the ECV procedure.  One potential method of improving ECV success is to elevate 
the fetal buttocks during the procedure, although this has been poorly studied.  One group reported 
that they had zero successful ECV procedures when the buttocks were lower than -1 station, versus 
a 66% success if the buttocks were at or higher than -3 station. 
 
The Safe Obstetric Systems Inc. Fetal Pillow is a balloon device approved by the United States 
Food and Drug Administration (FDA) for elevating the fetal head during cesarean deliveries 
performed during the 2nd stage, after the patient has been pushing. The device is placed into the 
vagina, filled with sterile saline, and inflated to push the head up and out of the pelvis.  Using the 
device to elevate the fetal buttocks prior to an ECV is an off-label usage of the product. Although 
unlikely, it is possible that the Fetal Pillow may decrease ECV success rates or cause unforeseen 
harm to the mother or fetus.   
 

 
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The objective of this research project is to assess the efficacy of the Fetal Pillow during ECV 
procedures for nulliparous women without regional anesthesia. 
 
Study Objectives 
Primary Objective 
The primary objective of this study is to evaluate the successful conversion of a breech to vertex 
presentation. Successful conversion will be confirmed via ultrasound immediately following the 
ECV procedure.     
 
Secondary Outcomes  
Maternal outcomes: 
1. MRN 
2. Age  
3. Weight 
4. Height 
5. Body mass index 
6. Ethnicity 
7. Gravidity (total number of pregnancies including this one) 
8. Parity (births > 20 weeks) 
9. Number of vaginal deliveries 
10. Number of cesarean deliveries 
11. Measurement of inferior aspect of rib to pubic symphysis 
12. Date and time of delivery 
13. Induction 
14. Presence of vaginal delivery (SVD or OVD) 
15. Presence of vacuum assisted delivery 
16. Presence of forceps assisted delivery 
17. Presence of cesarean delivery 
18. Fetal presentation at time of delivery 
19. Presence of postpartum hemorrhage (> 1,000 mL of measured blood loss) 
20. Presence of placental abruption 
21. Presence of shoulder dystocia 
22. Date and time of discharge after delivery 
23. Length of stay 
24. Cost of hospital stay (labor and delivery) 
25. Patient zip code 
26. Patient insurance 
 
Neonatal outcomes: 
1. Presence of stillbirth 
a. If stillbirth, estimated gestational age this occurred (weeks and days) 
2. Birthweight (grams) 
3. Apgar score at 1 minute 
4. Apgar score at 5 minutes 

 
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5. Presence of neonatal intensive care unit admission 
6. Presence of intubation 
7. Presence of neonatal humeral fracture 
8. Presence of neonatal clavicle fracture 
9. Presence of neonatal skull fracture 
10. Neonatal length of stay 
11. Cost of neonatal stay 
 
Procedural Outcomes 
1. Date of procedure 
2. Time of procedure  
3. EGA 
4. Name of obstetrician performing ECV procedure 
5. Presence of inflated Fetal Pillow 
6. Presence of terbutaline 
7. Presence of palpable fetal head 
8. Estimated fetal weight (kg) 
9. Fetal head position *confirmed by ultrasound 
10. Fetal back position 
11. Position of fetal neck 
12. Location of placenta 
13. Amniotic fluid index (4 quadrant total) 
14. Fetal station (-3 through +3) 
15. Maternal cervical dilation (cm) 
16. Presence of rupture of membranes within 1 hour of procedure 
17. Presence of 3 or more contractions in 10 minutes immediately prior to procedure 
18. Bleeding equal to a menstrual period during or within 1 hour of the ECV procedure. 
19. Development of a pelvic hematoma during or within 1 hour after the ECV procedure. 
20. Development of a vaginal laceration during insertion of the device, the ECV procedure, or 
removal of the device.   
21. Presence of fetal bradycardia 
22. Presence of fetal heart rate decelerations 
23. Presence of delivery within 1 hour of procedure 
24. VAS pain score immediately prior to ECV (-3 minutes)  
25. VAS pain score immediately after insertion of Fetal Pillow (+ 2 minutes)  
26. VAS pain score after inflation/sham inflation (+ 1 minute) 
27. VAS pain score immediately after each ECV procedure attempt, maximum of 4 attempts 
(+ 2 minutes) 
28. Total number of attempts 
29. Procedure successful Y   N (Primary Outcome) *confirmed by ultrasound 
30. Fetal head position post ECV *confirmed by ultrasound  
31. Number of forward rolls 
32. Number of reverse rolls 
33. Note which procedure was successful 

 
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34. Did patient request to have spinal or epidural anesthesia after initiation of ECV procedure 
(off of study protocol): Y  N 
35. Presence of regional anesthesia prior to ECV procedure (Excluded from study) 
36. Length of time from start of procedure to hospital discharge 
37. Cost of hospital stay for ECV procedure 
 
 
Study Design 
Research Design 
This is a prospective, randomized double-blind clinical trial evaluating the effect of a balloon 
device to elevate the fetal buttocks during external cephalic version procedures.  Eligible study 
population: pregnant women between 37-40 weeks estimated gestational age with a breech 
presenting baby and no contraindications to ECV.   
 
Study Agent, Device, and/or Intervention Description:  
The Safe Obstetric Systems Inc. Fetal Pillow is a sterile balloon device that comes in a sterile, 
single-use package (please see attached information).  The Food and Drug Administration (FDA) 
has reviewed this device and determined it to be Non-Significant risk (NSR) because it does not 
meet the definition of a significant risk (SR) device under 21 CFR 812.3(m) of the investigational 
device exemptions (IDE) regulation (21 CFR 812).The device will be provided at no charge to 
AdventHealth Orlando.  Drs. Hill or Lense will place the pillow  into the vagina then the pillow 
will either be inflated/sham inflated by the midwife/physician  with sterile saline in order to raise 
the fetal presenting part.  After the procedure the device is deflated, removed and discarded. The 
Fetal Pillow device will be stored in a climate-controlled, locked storage area in the women’s 
hospital accessible to the study investigators, midwife/physician and research personnel.  It is 
possible that the manufacturer of this device may report de-identified study data to the FDA at a 
later date.   
 
Study Site/Location and Number of Subjects 
• AdventHealth Orlando.  
• Estimated number of subjects: 138 
 
Multi-Site Research Logistics/Communication Plan: N/A 
 
Research Conducted in a Foreign Country: N/A 
 
Community-Based Participatory Research: N/A 
 

 
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Subject Selection 
Vulnerable Populations: 
While the study population consists solely of pregnant women (some of whom may be 
AdventHealth Orlando employees), this research is unlikely to present more than minimal risk to 
subjects. This device has been used successfully to elevate the fetal head during difficult cesarean 
deliveries, and is FDA approved for this indication.  If the device functions similarly to elevate the 
fetal buttocks, it may improve the success rate for the external cephalic version procedure, thus 
decreasing the risk that pregnant women may need a cesarean delivery.  Because this research 
involves a procedure unique to pregnancy, it requires consent from pregnant patients.  Patients 
unable to understand the consent process are excluded. 
 
Inclusion Criteria 
 
1. Breech presenting part as diagnosed by bedside sonography. 
  
2. Pregnancy is between 37-40 weeks gestational age.  
3. Live fetus.  
4. Patient is >/= age 18.   
5. Patient speaks English or Spanish as primary language.  
6. Patient able to understand verbal and written consent 
 
Exclusion Criteria 
1. Non-breech presentation (cephalic, transverse, oblique). 
2. More than 1 fetus.  
3. Cervical dilation of >/= 1cm.  
4. Prior uterine incision.  
5. Congenital uterine anomaly. 
6. Body mass index more than 40 kg/m2. 
7. Uterine fibroids causing soft tissue dystocia. 
8. Extended fetal neck. 
9. Oligohydramnios (4-quadrant amniotic fluid index </= 5cm). 
10. Spontaneous rupture of membranes.  
11. Any contraindication to vaginal delivery (ie placenta previa, placental abruption, active    
      genital herpes outbreak).  
12. Intrauterine growth restriction (estimated fetal weight </= 10%ile). 
13. Estimated fetal weight > /= 5,000 grams for non-diabetic patient or >/= 4,500 grams for   
      patient with pre-existing or gestational diabetes, confirmed by ultrasound.  
14. Fetal gastroschisis. 
15. Fetal neural tube defect.  
16. Severe-range preeclampsia.   
17. Patient had regional anesthesia immediately prior to ECV.  
 

 
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Resources Available 
Team members have been involved in the development of the study protocol and analytic plan.  
Dr. Hill is the chair of the obstetrics and gynecology department of the AdventHealth Orlando 
Graduate Medical Education program, has authored numerous peer-reviewed publications and is 
an expert reviewer for several journals.  Dr. Lense is the medical director of the AdventHealth 
Orlando Obstetric Specialists team and has authored several medical journal articles.   An honest 
broker working in the department of Advent Health Children and Women Clinical Analytics. 
 
Study Procedures 
Subject Recruitment and Screening: Researchers will mail, fax and email an informational 
sheet describing the study, list inclusion and exclusion criteria, and provide contact 
information for obstetric providers to contact the researchers to discuss whether their 
patient qualifies for study inclusion. 
 
If eligible, either Dr. Hill or Lense will contact the patient to discuss study participation, 
answer questions, and schedule the procedure, in coordination with the labor unit 
scheduling staff. 
 
Consent Process: Potential research subjects will be screened for inclusion and exclusion criteria 
and scheduled for their ECV procedure.  Dr. Hill or Dr. Lense will review the ECV procedure with 
the subject including the potential risks versus benefits of the Fetal Pillow device. Subjects will 
also receive written information at the hospital and will sign an informed consent document (HRP 
500). At this time subjects will receive a screening number, which will be obtained from the master 
subject list. Researchers will follow HRP-802 and HRP-803 for guidance when obtaining informed 
consent. (Declining participation will not impact patient care: patients who do not consent to 
participate but who also want an ECV procedure will undergo an attempted ECV outside of the 
study protocol).    
 
Documentation of Informed Consent Process 
 
Documentation of the informed consent process is required to establish that the subject was 
accurately and adequately informed and that no study-related procedures were initiated prior to 
obtaining informed consent.  A research team member will note in the source documentation the 
consent process, date and time consent was obtained and that consent was obtained prior to 
initiating any research procedures. 
 
Non-English Speaking Subjects:   
Dr. Lense is fluent in Spanish and will consent patients verbally (Spanish) and in 
writing (consent form written in Spanish).  

 
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Subjects who are not yet adults (individuals under the age of 18): N/A 
Cognitively Impaired Adults: N/A  
Adults Unable to Consent: N/A 
Waiver of Consent:  N/A  
 
Randomization:  
Patients will be randomized 1:1 using a block scheme using statistical software.  Randomization 
assignments will be sealed into sequentially numbered, opaque envelopes which are stored in the 
locked study cabinet on the labor and delivery unit. A trained unblinded practitioner will obtain 
the randomization envelope from the locked study cabinet and will note the randomization number 
on the randomization form.   The subject master list will be kept electronically in the Teams files 
only accessible by Drs. Hill, Lense and the research personnel. Only Drs. Hill, Lense, trained 
midwives/physicians and research coordinators  will have access to the locked study cabinet.  
 
Study Visits:  
 Visit 1 (ECV Procedure):  The PI/Sub-I will meet the patient at the labor and delivery area, 
and review both the ECV procedure and possible study inclusion.  The patient and 
researcher will sign consent forms if the patient qualifies for study inclusion and agrees to 
participate. 
 
After weighing the patient, calculating a body mass index, performing a digital cervical 
exam, and performing a fetal non-stress test and obstetric ultrasound, all routine 
components of the ECV process, the PI/Sub-I will verify there are no exclusion criteria.  
Assuming that an ECV is still necessary and safe, the patient will receive a 0.25mg 
subcutaneous injection of terbutaline, a medication to quiet the uterus that is commonly 
used for ECV procedures.  The midwife/physician performing the device inflation or sham 
inflation will open the randomization envelope. The researchers are blinded to patient 
randomization.  All patients will mark a line on a 100mm VAS to assess pre-procedure 
pain. 
 
The researcher will show the patient the device, open the sterile container, and insert the device 
into the vagina per manufacturer’s guidelines for all patients in the study.  All patients will mark 
a line on a 100mm VAS to assess post-insertion pain. The study physician will then obtain the 
assistance of a trained midwife/physician to inflate the device or perform a sham inflation.  For 
the physician to remain blinded, the physician will leave the room during the time of the 
inflation/sham inflation.   This will be documented in the source documents.  Midwives/Physicians 
performing the inflation or sham inflation will have undergone previous training.  Inflating the 

 
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Fetal Pillow is similar, although less difficult, than other balloon devices commonly used on the 
labor and delivery unit.  The assisting midwife/physician will inflate the device with180 mL of 
saline for those patients randomized to inflation.  This will occur under a sheet so that the patient 
is blinded to the randomization scheme.  If the patient is randomized to no inflation, the 
midwife/physician will perform a sham inflation, also under a sheet.  All patients will mark a line 
on a 100mm VAS to assess post-inflation/sham inflation pain.  The assisting midwife/physician 
then leaves the room, and the study physician reenters the room and proceeds with the ECV 
procedure. 
 
Regardless of randomization, at this point the ECV procedure proceeds using normal routine. Once 
completed, all patients will mark a line on a 100mm VAS to assess post-ECV pain. The ECV will 
be attempted up to four times and VAS will be assessed after each attempt.  
 
The research physician will then remove the Fetal Pillow and perform a post procedural ultrasound 
to verify fetal position. Regardless of randomization, the procedure is completed per the usual 
routine of fetal monitoring, assessing for labor or bleeding, discussing post-procedure care, then 
discharge home (or, less likely, admitting for either observation or delivery).   
 
The researcher will fill out the ECV portion of the data collection form.   
 
Visit 2 (Labor and Delivery):  There are no study interventions during this visit.  The file linking 
the subject’s FIN and study numbers will be sent to the honest broker who will then extract the 
data  for delivery outcomes for the mother and neonate along with the final cost calculations  This 
data will be entered into a spreadsheet by the honest broker and then sent back to the research 
team.  The research team will send the file linking the subject’s FIN and study numbers at the 
intervals outlined in the safety monitoring plan (first 10 randomized subjects and every 20 subjects 
thereafter). The investigators are unblinded to patient randomization after the ECV procedure has 
been completed and during data collection for delivery and neonatal outcomes.  
 
Data collection for patients delivering outside of AdventHealth facility. Patients will sign a release 
of records; study coordinator will request records from delivering facility and delivery outcomes 
data will be imported into spreadsheet linked to FIN.  
 
Study Duration:  
Estimated date of study completion: March 31, 2023 
• Projected start date:  November1, 2020. 
• Projected completion of enrollment of all study subjects:   November1, 2022. 
• Projected final data collection date:  March 1, 2023.  
 
Materials of Human Origin: N/A 
    

 
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Study Outcome Measures (Endpoints) 
 
Primary Outcome: 
 
Proportion of patients undergoing ECV who have a successful outcome with and without an 
inflated Fetal Pillow. 
 
Secondary Outcomes: 
 
As noted, many of these data points are normally recorded in the medical record during an ECV 
procedure and subsequent delivery, regardless of study participation.  
 
Subject Information (maternal): 
Demographic information of the patient will be collected in the electronic medical record (EMR) 
by noting ethnicity, number and type of prior deliveries, and measuring height and weight.    
 
Subject Information (neonatal): 
 
Neonatal gestational age at delivery, weight, 1 and 5 minute Apgar scores will be recorded from 
the medical record..  
 
Pain perception:   
Patients will complete a VAS pain scale prior to and after the ECV procedure as well as after the 
insertion of the fetal pillow and after the inflation/sham inflation of the pillow.   
 
Impact of maternal parameters on successful ECV: 
Researchers will measure the distance from the inferior aspect of the ribs to the pubic symphysis 
using a tape measure, location of placenta by performing an obstetric sonogram, and cervical 
dilation by performing a digital cervical examination.    
 
Impact of fetal parameters on successful ECV: 
A digital vaginal examination will determine the location of the fetal buttocks in the pelvis. The 
fetal head will be assessed to determine if it can be palpated on abdominal exam. The physician 
will perform an obstetric ultrasound and measure estimated fetal weight, amniotic fluid index, and 
position of the fetal neck.   
 
Outcome of ECV procedure:  Researchers will document the fetal heart rate pattern, and whether 
bleeding, contractions, labor, or rupture of membranes occur.  If rupture of membranes is 
suspected, it will be confirmed by sterile speculum examination and testing of the amniotic fluid 
for ferning or nitrazine.  The number and type of ECV maneuvers will be recorded.  Bleeding, 
development of a vaginal hematoma, and delivery within an hour of performing the ECV 
procedure will be recorded.   

 
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Delivery Outcome (maternal): 
Researchers will record the fetal presentation at labor admission, type of delivery, whether there 
was a shoulder dystocia, and the blood loss as measured by weighing any saturated sponges from 
the medical record.   
 
Delivery Outcome (neonatal):   
Researchers will measure the neonatal weight, 1- and 5-minute Apgar scores, whether the baby 
was stillborn, had a bone fracture, or was intubated and/or admitted to the neonatal intensive care 
unit from the medical record.   
 
 
Length of Stay: 
Researchers will record the length of stay for mothers for the ECV procedure, and length of stay 
for both mothers and neonates for the admission for delivery, all measured in hours.    
 
Cost of Stay: 
Researchers will record the cost of stay for both mothers and babies, for both the ECV procedure 
and the admission for delivery. This will be obtained from the mother’s and child’s medical 
record.  
 
Data Management and Quality Plan 
Data De-identification 
Data will be de-identified prior to analysis. Each patient will be assigned a 4-digit code that will 
not contain any unique identifiers. The code will be linked to the patient’s FIN which will be stored 
in a separate file on a password-protected laptop stored in a locked office.  The de-identified data 
will be stored in a similar fashion in a separate file.  Drs. Hill, Lense, the research department 
personnel and the honest broker will have access to both files. We anticipate that once data is 
entered for each individual patient, the link will be used only for the purposes of random audits to 
ensure data accuracy. Once data has been analyzed and results have been published, the link to the 
de-identified data will be destroyed after 7 years. As the assigned study number will not be linked 
to any PHI, we do not foresee any possible breach occurring. 
 
Data Confidentiality, Storage, and Retention 
Study documentation and paperwork will be stored behind 2 locked doors in the Center for 
Pediatric & Women’s Research Department during the active study period. Upon study closure 
the paper records will remain in the research office for storage. The data file will be stored 
electronically on a password protected secure server at AdventHealth accessible only to study team 
members as listed on the personnel log. Study documentation will be retained for 7 years after 
study completion. After that period, paper records will be placed in hospital approved shred bins. 

 
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Electronic records will be placed in a computer electronic trash bin followed by immediate 
emptying of the electronic trash bin.     
 
Data Quality  
Quality control procedures for this study include source data verification by randomly selecting 
10% of subjects (9 if enrollment goal is met) and verifying all values. If more than one discrepancy 
is found, an additional 10% of subjects will be checked. Based on those findings, additional 
subjects or all subjects may be verified. The AdventHealth Office of Research Integrity will create 
a monitoring plan and conduct internal monitoring of the study for patient safety and data integrity. 
 
Clinical trial monitoring is conducted to ensure that the rights and well-being of trial participants 
are protected.  Reported trial data are accurate, complete and verifiable.   
 
Clinical trial monitoring will be conducted by AdventHealth Office of Research Integrity 
monitoring team to ensure compliance with all applicable federal and state regulations, ICH GCP 
E6 (R2) standards and approved protocol.  This study will be monitored using a risk-based 
approached.  A monitoring plan will be created to ensure patient safety, data quality and integrity 
is ongoing throughout the life of the study.  The frequency and elements of monitoring will be 
outlined in the monitoring plan.  The monitor will ensure study is conducted, recorded and reported 
as required by federal regulations and IRB of record.  Monitoring will be conducted on-site and/or 
remote.  After completion of site monitoring, a report will be provided to PI and study team.  The 
PI and study team are required to review the report and work on significant findings or 
discrepancies to resolution.  If any findings are required to be reported to the IRB, the PI will be 
made aware and prompted to self-report.  All serious and continuing non-compliance is shared 
with the Research Oversight Committee who may require appropriate actions. 
 
Protocol Deviations 
All deviations and SAEs must be reported promptly to AH ORI and regulatory team.  SAEs must 
be reported within 24 hours of discovery. Any SAE required to be reported to the FDA and IRB 
will be completed with the assistance of the central regulatory team in conjunction with the 
principal investigator and study team.” 
 
Data Sharing (outside of AdventHealth Orlando): N/A  
 
Sample Size Determination 
Based on prior studies of patients without regional anesthesia who had a success rate of 
approximately 49%, and assuming a 1:1 allocation of intervention and control subjects, with an 
80% power, and a 2-sided 5% significance level, we calculated a sample of size of 69 in each 
group to increase the success rate from 49% to 73.5%.  Assuming a 10% case dropout rate we will 
enroll 76 patients in each arm (152 total participants). 
 

 
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Statistical Analysis Plan 
Primary Objective Analysis 
The success of ECV procedures for the intervention group compared to the control group will be 
analyzed using chi-square and Fisher exact tests.  A P value of <0.05 will be considered statistically 
significant.  
 
Secondary Objective Analysis 
Maternal and neonatal outcomes will be analyzed using chi-square and Fisher exact tests for 
categorical variables, unpaired t-tests for continuous variable, and non-parametric tests for 
continuous variables that are not normally distributed.  P values <0.05 will be considered 
statistically significant. 
 
Potential Risks and Benefits 
Potential Benefits 
The Fetal Pillow device may improve the ECV success rate. 
 
Potential Risks  
Although unlikely based on prior device usage during 2nd stage arrest, it is possible the 
device may cause vaginal bleeding, increased pain during the procedure, or either no 
change in success or a lower success rate compared to performing the procedure without 
the device.  Terbutaline administration may cause maternal tachycardia, irritability, chest 
pressure or chest pain. While loss of confidentiality is a potential risk to patients, patient 
information will be de-identified prior to analysis and only study personnel will have access 
to patient information. The United States Food and Drug Administration has determined 
that this study protocol is a nonsignificant risk (NSR) study (Review # Q191927, 
notification received December 18, 2019). 
 
Mitigation of Risks 
Patients will be asked prior to administration of terbutaline if they have contraindications, 
which is standard practice prior to using this medication. 
 
Provisions to Protect the Privacy Interest of Subjects 
The steps to protect the privacy of subjects have been described previously. Briefly, study 
documentation and patient information will be stored in a separate file on a password-protected 
laptop stored in a locked office.  Drs. Hill, Lense and research team will have access to both files. 
 
Early Withdrawal of Subjects 
Investigator Withdrawal of Subjects. 
 

 
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Inability to place Fetal Pillow: If the Fetal Pillow cannot be placed, for example due to pain, or the 
Fetal Pillow cannot be inflated, the patient will be withdrawn from the study.  However, she may 
undergo an attempted ECV outside of the study protocol if she wishes.   
 
Delivery at a hospital outside of the AdventHealth Orlando system:  If the patient delivers outside 
of the AdventHealth Orlando system she will be withdrawn from the study analysis.  
 
Subject Request for Withdrawal from Study 
 
Patient requests withdrawal:  Patients who request withdrawal for any reason will be immediately 
withdrawn.  If a patient initially consents to have the Fetal Pillow placed, then changes her mind 
before or during the procedure, the researcher will remove the device and offer the patient the 
opportunity to proceed with an ECV attempt off-protocol.  Researchers will ask the patient if they 
can complete data collection for delivery and proceed according to the patient’s wishes.  There are 
no known or suspected harms from withdrawing from the study.  
 
Data Collection and Follow-up for Withdrawn Subjects 
 
Patients electing to withdraw from the study will be asked if they consent to data collection for 
delivery.  If they decline this, then data collection will discontinue, and the data collection sheet 
will be stored as deidentified data in case the patient’s reason for withdrawal (for example, 
excessive pain) is identified as a side effect of the device.  The percentage of patients withdrawing 
and the reasons for withdrawal will be calculated and included in any manuscript submissions.    
 
Adverse Event Reporting 
 
Adverse events will be collected from the time of insertion up to 1 hour after the ECV procedure 
and followed until discharge. Adverse events such as excessive pain or bleeding will be recorded 
as part of the data collection.  Adverse events of special interest will be reported according to 
AdventHealth Orlando IRB policies  
 
Adverse events of special interest include:  
 
Term 
Mild 
Moderate 
Severe 
Serious 
Serious 

 
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Vaginal 
Hemorrhage  
Mild 
symptoms; 
intervention not 
indicated 
Moderate 
symptoms; 
intervention 
indicated 
Transfusion 
indicated; invasive 
intervention 
indicated; 
hospitalization 
Life-threatening 
consequences; 
urgent 
intervention 
indicated 
Death 
Pelvic 
Hematoma 
Mild 
symptoms; 
intervention not 
indicated 
Minimally 
invasive 
evacuation or 
aspiration 
indicated 
Transfusion; invasive 
intervention indicated 
Life-threatening 
consequences; 
urgent 
intervention 
indicated 
Death 
Vaginal 
Laceration 
Separation of 
the perineal 
skin only 
Injury to the 
perineal 
muscles but 
not the 
sphincter or 
rectum 
Injury to the perineal 
muscles and anal 
sphincter 
Injury to the 
perineal 
muscles, 
sphincter, and 
rectal mucosa 
Death 
Premature 
ruptured 
Membrane 
Confirmed 
rupture of 
membranes 
Rupture of 
membranes 
leading to 
immediate 
discontinuation 
of ECV 
procedure 
Rupture of 
membranes leading to 
immediate labor 
induction 
 
Life-threatening 
consequences; 
Cord prolapse 
resulting in fetal 
harm, defined 
as umbilical 
artery PH < 5 or 
admission to 
NICU 
Cord 
prolapse 
resulting 
in fetal 
death 
Other 
Mild 
symptoms; 
intervention not 
indicated 
Minimal, local 
or noninvasive 
intervention 
indicated 
Medically significant 
but not immediately 
life-threatening 
Life-threatening 
consequences; 
urgent 
intervention 
indicated 
Death 
 
• 
Severity of an adverse event will be determined and classified as described above by the 
Investigator.  
 
• An unanticipated adverse device effect: any serious adverse effect on health or safety or 
any life-threatening problem or death caused by, or associated with, a device, if that effect, 
problem, or death was not previously identified in nature, severity, or degree of incidence 
in the investigational plan or application (including a supplementary plan or application), 
or any other unanticipated serious problem associated with a device that relates to the 
rights, safety, or welfare of subjects (21 CFR 812.3). 
o Sponsor will comply with FDA regulations 21 CFR 812.46 for monitoring 
requirements. 
 

 
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Relatedness/Causality of an adverse event will be determined and classified as described 
below by the Investigator.  
 
Classification 
Definition 
Related 
An event that results from the presence or performance (intended or 
otherwise) of the investigational device. 
Unknown 
An adverse event that cannot be determined to have a causal 
relationship with the device 
Not Related  
An adverse event that has been determined to not have a causal 
relationship with the device 
 
Serious Adverse Event Reporting 
 
A serious adverse event is defined as an adverse event “if, in the view of the investigator, it results 
in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization 
or prolongation of existing hospitalization*a persistent or significant incapacity or substantial 
disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. 
Important medical events that may not result in death, be life-threatening, or require hospitalization 
may be considered serious when, based upon appropriate medical judgment, they may jeopardize 
the patient or subject and may require medical or surgical intervention to prevent one of the 
outcomes listed in this definition.  
 
*Planned hospitalization for a pre-existing condition, or a procedure required by the clinician that is 
not related to the device, will not be considered a Serious Adverse Event.  
 
Only SAEs deemed related to the device will be reported electronically to the FDA and AHIRB no 
later than within 10 working days after the investigator first learns of the event (21 CFR 
812.150(a)(1)).  
 
 
Safety Monitoring Plan   
Safety Monitoring 
 
While we consider the project to be relatively low risk, there is always the possibility of adverse 
events. The safety monitoring plan will include: (1) review of interim analyses of outcome data; 
(2) review of reports of related studies to determine whether the monitored study needs to be 
changed or terminated; (3) review of major proposed modifications to the study prior to their 
implementation; and (4) provide the study leadership with written recommendations concerning 
the trial including continuing, changing or terminating the study.  Safety monitoring will occur 
after the first 10 randomized subjects and every 20 subjects thereafter. Rachel Humphrey M.D., 
Chair of Fetal Medicine Department and Vicki Smith R.N., Nurse Manager Labor and Delivery 
Unit will conduct the safety monitoring plan.  
 

 
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Data and Safety Monitoring Board (DSMB) or Equivalent: N/A 
 
Ethical Considerations 
N/A 
 
Sharing of Results with Subjects 
Patients will be immediately aware if the ECV procedure was successful.  Upon completion of 
study data analyses, subjects will have the option to contact study team to obtain their 
randomization arm information. 
 
Funding Source 
There is no external funding for this research.  The manufacturer of the Fetal Pillow has agreed to 
supply devices and have not been involved in the study design.  
 
Subject Stipends or Payments: N/A 
 
Publication Plan 
The plan is for presentation and publication of the study findings.  The roles and responsibilities of 
each research team member have been determined, and assignment of authorship has occurred.  
ICMJE guidelines have been followed.   
References 
 
1) Hickok DE, Gordon DC, Milberg JA, Williams MA, Daling JR.  The frequency of breech 
presentation by gestational age at birth: a large population-based study.  Am J Obstet 
Gynecol. 1992;166(3):851. 
2) Hofmeyr GJ, Hannah M, Lawrie TA. Planned caesarean section for term breech delivery. 
Cochrane Database Syst Rev. 2015. 
3) Ezra Y, Elram T, Plotkin V, Elchalal U.  Significance of success rate of external cephalic 
versions and vaginal breech deliveries in counseling women with breech presentation at term. 
Eur J Obstet Gynecol Reprod Biol 2000;90(1):63-6. 
4) Ebner F, Friedl TW, Leinert E, Schramm A, Reister F, Lato K, Janni W, DeGregorio N. 
Predictors for successful external cephalic version: a single centre experience.  Arch Gynecol 
Obstet 2016;293(4):749-55. 
5) Kok M, Cnossen J, Gravendeel L, van der Post J, Opmeer B, Mol BW.  Clinical factors to 
predict the outcome of external cephalic version: a metaanalysis. Am J Obstet Gynecol. 2008 
Dec;199(6):630.e1-7; discussion e1-5. doi: 10.1016/j.ajog.2008.03.008. Epub 2008 May 23. 
6) Weiniger CF1, Ginosar Y, Elchalal U, Sharon E, Nokrian M, Ezra Y. External cephalic version 
for breech presentation with or without spinal analgesia in nulliparous women at term: a 
randomized controlled trial. Obstet Gynecol. 2007 Dec;110(6):1343-50. 
7) Newman RB, Peacock BS, VanDorsten JP, Hunt HH.  Predicting success of external cephalic 
version.  Am J Obstet Gynecol.  1993;169:245-50.   
8) Safe Obstetrics Systems.  https://www.safeob.com/  (Accessed April 14, 2020).  

 
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9) Lassey, SC, Little SE, Saadeh M, Patton N, Farber M, Bateman B, et al.  Cephalic Elevation 
Device for Second-Stage Cesarean Delivery.  Obstet Gynecol.  2020;135:879-884.   
10) Seal SL, Dey A, Barman SC, Kamilya G, Mukherji J1, Onwude JL.  Randomized controlled 
trial of elevation of the fetal head with a fetal pillow during cesarean delivery at full cervical 
dilatation.  Int J Gynaecol Obstet. 2016 May;133(2):178-82. doi: 10.1016/j.ijgo.2015.09.019. 
Epub 2016 Jan 15.