Intraoperative Fetal Heart Rate (FHR) Monitoring: a Feasibility Study
Conditions: Fetal Monitoring, Labor, Obstetric
Sponsor: Washington University School of Medicine

 
 
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RESEARCH PROTOCOL 
 
 
 
STUDY TITLE 
 
 
Intraoperative Fetal Heart Rate (FHR) monitoring: a Feasibility Study 
 
 
 
PI Name: Heather McKenzie, MD 
PI Title: Assistant Professor of Anesthesiology 
Washington University School of Medicine 
Department of Anesthesiology 
660 South Euclid Avenue 
Campus Box 8054 
St. Louis, MO, 63110 
Voice: 314-362-2628 
Fax: 314-362-9037 
E-mail: mckenzieh@anest.wustl.edu 
 
 
 
 
Version Date:  September 20, 2016 
 

 
 
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the agreement by the recipient that no unpublished information contained herein will be published or disclosed without prior 
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1.  SYNOPSIS 
 
Study Title 
Intraoperative fetal heart rate (FHR) monitoring: a Feasibility Study 
 
 
Objective 
The introduction of intraoperative fetal heart rate (FHR) monitoring; 
demonstrating that intraoperative FHR monitoring is technically 
feasible. 
Study Period 
Planned enrollment duration: 6 months 
 
Planned study duration: 6 months 
 
Number of Patients 
55 patients 
 
Study Treatment  
 
 
Study Design 
 
Observational Study 
Inclusion and 
Exclusion Criteria 
Inclusion Criteria: 
1. First 15 patients only– Elective induction of labor, not yet in 
active labor. 
2. Subsequent 40 patient – Scheduled cesarean sections performed 
under spinal anesthesia 
3. Patients ages 18-45 
Exclusion Criteria 
1. Urgent or emergent cesarean sections 
2. Cesarean sections performed under general anesthesia 
 
 
 
Statistical 
Methodology 
Demographic, clinical characteristics will be summarized using descriptive 
statistics 

 
 
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2.  STUDY PROTOCOL  
 
2.1 Background and Significance 
 
Fetal heart rate (FHR) monitoring has become the most widely used assessment of fetal well-being in 
the peripartum period and the only routinely used method that provides continuous fetal monitoring. 
Despite a false positive rate for the detection of intrapartum asphyxia leading to cerebral palsy of 
over 99% [1-3] FHR monitoring continues to be the mainstay of peripartum fetal surveillance. FHR 
monitoring is routinely available in the operating room, where it is typically reassessed in cases of 
urgent cesarean delivery for fetal distress since it may direct immediate anesthetic and peripartum 
management. However, despite the ubiquitous use of FHR monitoring in labor and the typical use of 
FHR monitoring on arrival to the OR, FHR monitoring is universally stopped once anesthesia has 
been performed in order to allow abdominal skin preparation and for surgery to proceed. From the 
moment of anesthesia induction until fetal delivery, no real-time data is available that allows 
assessment of fetal well-being. A few isolated studies and case reports in the 1970s-1980s examined 
intraoperative FHR monitoring using scalp-clip electrodes during Cesarean deliveries [4-7]. None of 
these studies assessed external FHR monitors or current anesthesia techniques. To our knowledge no 
studies since that time have examined FHR monitoring during Cesarean deliveries using external 
monitoring or spinal anesthesia.  
 
2.1.1 Preliminary Data 
 
None 
 
2.2 Objective 
 
The first objective of this study is the introduction of intraoperative fetal heart rate (FHR) monitoring 
as a novel fetal endpoint to be utilized in scheduled and urgent cesarean deliveries, in order to shed 
important light on the immediate fetal responses to maternal anesthetic and obstetric interventions. 
This research is intended to demonstrate that intraoperative FHR monitoring is technically feasible, 
and correlates with other traditional endpoints of immediate neonatal wellbeing (such as umbilical 
arterial blood gas analysis and Apgar score). Unlike these post-delivery neonatal outcomes, 
intraoperative FHR monitoring has the potential to serve as a real-time target for optimization of 
maternal and fetal condition in order to improve immediate neonatal outcome. We will first assess  
the fetal ECG monitors on a pilot of 15 patients for induction of labor who are not yet in active labor 
or in pain; the aim being to determine the best placement of the ECG leads. We will then assess the 
technical feasibility of intraoperative FHR monitoring using both the standard abdominal wall 
acoustic device used routinely in labor and a series of multiple ECG leads placed over the upper 
abdominal wall.  

 
 
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2.3 Patient Selection 
 
Patients enrolled in this study series will first be patients undergoing elective induction of labor 
(15patients) and then patients undergoing elective cesarean delivery (40 patients.) 
 
2.3.1 Inclusion Criteria 
1. First 15 patients only– Elective induction of labor, not yet in active labor. 
2. Subsequent 40 patient – Scheduled cesarean sections performed under spinal anesthesia 
3. Patients ages 18-45 
 
2.3.2 Exclusion Criteria  
1. Urgent or emergent cesarean sections. 
2. Cesarean sections performed under general anesthesia 
 
2.4. Study Design 
 
This will be an observational study to determine the feasibility of intraoperative FHR monitoring 
 
 
2.4.1 Study Procedures 
 
Patients enrolled in this study will be enrolled on the labor and delivery ward prior to their elective 
cesarean section.  This will be done with the help of research assistants/nurses. Patients will be 
provided with written information about the study that they are enrolled in (see below) and consented 
for participation in the study as well as use of collected non-identifiable information; information on 
FHR (fetal heart rate) monitoring.  
 
2.4.2 Minimization of Bias 
 
The demographic sought in this study are female patients ages 18-45.  No other particular 
demographic will be sought. 
 
2.4.3 Pre-Study Period 
 
The pre-study period will involve education of research assistants/nurses and anesthesiology 
providers, evaluation of availability of resources (includes BioSemi ECG, Fetal heart rate Doppler).  
 

 
 
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2.4.4 Study Period 
 
The study period is anticipated to be 6 months. This will start  October 1st, 2016 
 
 
Methods: 
 
2.4.6 Observations and Measurements 
 
This will be an observational study. We will first assess the fetal ECG monitors on a pilot group of 
patients for induction of labor who are not yet in active labor or in pain. We will then assess the 
technical feasibility of intraoperative FHR monitoring. Fetal heart rate will be assessed by: 
  
a) External abdominal wall fetal ECG sensors placed at the top of the belly, outside the sterile 
field, or on the participant’s back. This data is captured via BioSemi FLAT Active electrodes that 
interface with an ECG system that employs the algorithm ActiView to analyze the data. [See 
Appendix A]..  
b) An acoustic fetal heart sensor, as used routinely in labor will be used as a comparator in 
this feasibility study. When this device is used intraoperatively, sterility and acoustic contact are both 
maintained by placing the acoustic probe inside a sterile nylon sleeve containing electrode gel, and by 
using sterile electrode gel between the sterile sleeve and the abdominal wall. This technique may 
require the presence of an investigator “scrubbed into” the case to hold the abdominal wall probe (ie 
surgical scrub, sterile gown and gloves). This will be decided on a case-by-case basis.  If needed, this 
investigator will need acoustic input to ensure adequate contact. So as not to distract the surgeon, this 
will be transmitted to the investigator by earphone input. These are scheduled cesarean deliveries and 
no fetal heart rate anomalies are expected; if there is an unexpected fetal bradycardia, this will be 
communicated to the surgeon. 
c) Routine maternal vital signs (heart rate, blood pressure and oxygen saturation). 
  
Group 1 – Patients for elective induction – not in active labor 
a) We will use the routine acoustic fetal heart rate sensor and try to determine the best 
placement of external abdominal wall fetal ECG sensors (either at the top of the belly 
outside the sterile field, or on the participant’s back 
b) We aim to capture 10 minutes of FHR with the ECG sensors comparing it to the acoustic 
monitor 
c) We will start with 5 patients.  If we are able to capture FHR for the allotted period of time 
with the fetal ECG, then we will proceed to the intraoperative group.  If not, we will 
assess another 5 elective induction patients.   
d) We will plan for an upper limit of 15 patients in this group 
 

 
 
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Group 2 – Patients for scheduled cesarean section 
a) We will use the acoustic FHR sensor and the fetal ECG sensors. 
b) We will start with 5 patients and determine if we can capture fetal ECG. If this 
information correlates with the acoustic FHR, we then use only the fetal ECG sensors for 
the remaining 35 patients. We will adjust placement of leads for each group of 5 patient if 
there proves to be difficulty with capturing FHR intraoperatively, though all leads will be 
placed on the belly outside the sterile field or on the participant’s back 
c) We will plan for an upper limit of 40 patients in this group 
 
 
 
2.4.6.3 Primary Outcome Measures 
 
 
The primary endpoint of the feasibility study is the use of external abdominal wall fetal ECG sensors 
to assess FHR; its use-friendliness, the signal-noise ratio and the correlation with acoustic data.  
 
 
2.4.6.4 Secondary Outcome Measures 
 
Secondary endpoints are the incidence of any non-reassuring FHR patterns during the "silent" period 
which is the period when the FHR monitor is removed, the patient’s abdomen is scrubbed, sterile 
prep and drape until delivery of the fetus. If there are any non-reassuring FHR patterns (tachycardia, 
bradycardia, decelerations), maternal vital signs at the time will be noted.  
 
2.4.6.5   Statistical Methods 
 
Demographic and clinical characteristics will be summarized using descriptive statistics; FHR data will be 
compared for the two tests using Receiver Operating Characteristic or ROC curve. 
 
2.4.6.6   Sample Size 
 
55 patients 
 
2.5 Management of Intercurrent Events 
 
Should something interfere with the collection of data that is other than disconnection of the FHR 
devices or loss of power, these will be noted and the attempt to rectify the situation will also be 
documented.  We will not however delay surgery in order fix the problem.  
 

 
 
CONFIDENTIAL: This document is the intellectual property of Heather McKenzie, MD.  Acceptance of this document constitutes 
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Monitoring of maternal blood pressure and treatment of hypotension will follow standard routine 
protocol. Maternal blood pressure data and vasopressor therapy will be recorded in metavision as 
routine.  
 
2.5.1 Adverse Experiences 
The likelihood of adverse events is very low as the devices that will be used in the study are ones that 
have been used in the obstetric population for years. The participants, will however be monitored for 
adverse experiences.  These events will be reported and the patients followed.  The possible adverse 
events with this study are allergic reaction/skin sensitivity to the adhesive used for the fetal ECG, 
impression left on the subjects body from the Doppler.  
 
2.5.2 Premature Discontinuation 
 
Patients will be withdrawn from the study upon request.  Patients will also be withdrawn from the 
study if it is believed to be in the best interest of the fetus or the patient. If a patient withdraws from 
any study in the series they will be replaced to maintain the estimated required number of patients for 
that particular study in the series. 
 
2.5.3 Potential Risks 
 
The potential risks in this study series involve the potential side effects/reactions to the 
electrocardiogram adhesive, Doppler and the psychological effects of being involved in a study.  We 
do not anticipate risks related to privacy invasion or socio-economic status.  
 
 
2.5.4 Procedures to Minimize Potential Risks 
 
Studies are conducted under the supervision of the PI and the co-investigators. The investigators are 
trained and experienced in performing research in human volunteer subjects. The investigators are 
anesthesiologists with extensive experience in the obstetric population.  As this is an observational 
study, patients will be treated and monitored as per usual standards of care. All investigation will 
occur in an operating room on labor and delivery. 
Inclusion and exclusion criteria, fasting requirements, monitoring, and the clinical protocol are 
designed to ensure that risks are absolutely minimal. Subjects are informed that participation is 
voluntary and they may refuse to participate and may withdraw from the study at any time without 
penalty. 

 
 
CONFIDENTIAL: This document is the intellectual property of Heather McKenzie, MD.  Acceptance of this document constitutes 
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2.5.5   Data and Safety Monitoring Plan 
 
Studies conducted in the Department of Anesthesiology follow the Washington University Institutional 
Review Board Policies and Procedures (last revision April 20, 2015). All individuals working on the study are 
required to read and be familiar with and compliant with the IRB Policies and Procedures. The specific 
monitoring plan for this investigation is commensurate with the risks and the size and complexity of the 
investigations planned. The potential risks are attributable to the potential side effects/reactions to the 
electrocardiogram adhesive, Doppler and the psychological effects of being involved in a study.  
Based on the small size and relatively low risk nature of the protocol, the investigating physicians are involved 
in the monitoring plan.  These individuals will review the annual summary of adverse events. All reports of a 
Serious Adverse Event, or an Unexpected Adverse Event will be reviewed immediately and reported as 
outlined in Section X of the IRB Policies and Procedures. 
 
 
3.  HUMAN SUBJECTS RESEARCH 
 
3.1 Protection of Human Subjects 
The study will be directed under the supervision of the primary investigator, a board certified, GCP 
certified anesthesiologist and a mentor with many years’ experience with human volunteer studies.  
The study team also involves additional anesthesiologists with experience in human volunteer 
studies. 
 
3.2 Sources of Materials 
 
The source of data for the study will come from the patient’s electronic record.  This information 
includes fetal heart rate, patient blood pressure, dose of vasopressor, patient cardiac output, fetal 
blood gases. 
 
3.2.1 List of Protected Health Information Collected for Study 
 
We do not anticipate using any of the 18 HIPPA privacy rule identifiers. 
 
3.2.2 Data Management 
 

 
 
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Fetal heart rate recorded by external abdominal wall fetal ECG sensors is captured via BioSemi FLAT 
Active electrodes that interface with an ECG system that employs the algorithm ActiView to analyze 
the data.[See Appendix A]. . 
 
With regard to confidentiality; 1) all subjects will be assigned a study ID number, 2) The link to 
identifiers will be destroyed at the end of the study 3) Paper data will be stored under lock and key 
(office, file cabinet) and only the investigators and research team will have access. Electronic data 
will be stored on a secure drive with limited individual password access.  If data are published, there 
will be no link to identifiers.  Study data will not be revealed to any organization, individuals other 
than the subjects, or the subjects themselves. 4) Maternal vital signs will be extracted from 
MetaVision and entered into a spreadsheet using only the study-specific ID.  None of the 18 HIPAA 
identifiers will be recorded for research purposes.  
 
 
3.3 Recruitment and Informed Consent 
 
Patients will be recruited for this study on the Labor and Delivery ward at Barnes Jewish Hospital.  
The recruiters in this study will be the current obstetric research nurses/assistants. The recruiter will 
enroll patients that are scheduled for an elective/non-urgent cesarean section. Research nurses will 
conduct phone screening recruitment by reviewing the Labor and Delivery schedule and contacting 
those patients having elective Caesarian deliveries the day before the surgery to inquire about their 
interest.  If interested, they will invite them to arrive a 30 minutes early for admission and obtain 
written informed consent prior to their procedure.  Potential participants will also be approached on 
the day of their procedure in the Labor and Delivery unit.  
3.4 Potential Benefits of the Proposed Research to the Subjects and Others 
 
There is not expected to be an immediately appreciable benefit to either the fetus or the patient in 
every study in the series.  Future patients/fetuses may benefits from a change in anesthetic 
management if any study in this series shows an improvement in fetal (improved Apgar scores, blood 
gases) or patient (improved blood pressure, cardiac output) outcome from any proposed regiment in 
this series. 
 
3.5 Inclusion of Women 
 
The patients/volunteers in this study series will exclusively be women.  
 
3.6 Inclusion of Minorities 

 
 
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This study series will make a large effort to include patients of all demographics as they are typically 
represented on the labor and delivery ward at Barnes-Jewish Hospital. 
 
3.7 Inclusion of Children 
 
Pregnant female patients ages 18-45 will be included in this study. 
 
 
4.  REFERENCES 
 
1. Low JA, et al. Obstet Gynecol. 1999; 93: 285-91. 
2. Nelson KB, et al. N Engl J Med. 1996; 334: 613-8. 
3. ACOG Practice Bulletin No. 106. ACOG. Obstet Gynecol 2009; 114: 192–202. 
4. Petrikovsky BM, et al. Int J Gynaecol Obstet. 1989; 29: 215-8. 
5. Petrikovsky BM, et al. Am J Obstet Gynecol. 1989; 161: 36-7. 
6. Petrikovsky B, et al. Int J Gynaecol Obstet. 1988; 26: 203-7. 
7. Timor-Tritsch I, et al.. Obstet Gynecol. 1976; 48: 292-6. 
 
 
 

 
 
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Appendix A.  BioSemi ECG System  
Per the BioSemi FLAT Active ECG System Standard Terms and Conditions of Sale:  
2. Intended Use 
2.1 
Our products are designed and intended to be used for research applications only. 
2.2 
Our products are not designed or intended to be used for diagnosis or treatment of disease. Our 
products are not sold as a Medical Device as defined in EU directive 93/42/EEC, Article 1, Sec 2 (a) 
(European Union), or as defined in the Federal Food Drug & Cosmetic (FD&C) Act, Chapter II, Sec 201 (h) 
(USA). 
2.3 
Our equipment is only authorized to be used on humans, if this application is explicitly stated in the 
respective manual. 
2.4 
Our products are not authorized for use as critical components in life support systems. As used herein: 
a) Life support systems are systems which (1) are intended for surgical implant into the body, or (2) support or 
sustain life, and whose failure to perform when properly used in accordance with the instructions for use 
provided in the labeling can reasonable expected to result in significant injury to the user 
b) A critical component is any component in a life support system whose failure can be reasonable expected to 
cause failure of the life support device or system, or to affect its safety or effectiveness 
 
21 USC 321[h] [revised Chapter 9, Subchapter II] cited in support of section 2.2 above states: 
(h) The term "device" (except when used in paragraph (n) of this section and in sections 331(i), 343(f), 352(c), 
and 362(c) of this title) means an instrument, apparatus, implement, machine, contrivance, implant, in vitro 
reagent, or other similar or related article, including any component, part, or accessory, which is- 
 
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any 
 
supplement to them, 
 
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, 
 
treatment, or prevention of disease, in man or other animals, or 
 
(3) intended to affect the structure or any function of the body of man or other animals, and which 
 
does not achieve its primary intended purposes through chemical action within or on the body of man 
 
or other animals and which is not dependent upon being metabolized for the achievement of its 
 
primary intended purposes.