Presence of a Companion During Performance of Neuraxial Labor Analgesia
Phase: NA
Conditions: Anxiety, Pain, Health Knowledge, Attitudes, Practice
Sponsor: Northwestern University

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PROTOCOL TITLE:  Impact of Companion Presence during Placement of Neuraxial 
Analgesia 
 
 
 
 
 
PRINCIPAL INVESTIGATOR: 
Feyce Peralta, M.D. 
Department of Anesthesiology 
(312) 472-3585 
feyce.peralta@northwestern.edu 
 
VERSION NUMBER: 
Version 1.0 
 
 
VERSION DATE: 
 
 
  11/11/2016 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
OBJECTIVES: 

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The purpose of the study is to evaluate the impact of the presence of a companion 
during epidural catheter placement for labor analgesia.  It will be focused on parturients 
having their first child.  Additionally, it will investigate the effect of ethnicity, health 
literacy (as evaluated by the Newest Vital Sign questionnaire), catastrophizing (as 
evaluated by the Pain Catastrophizing Scale), and the relationship of the companion to 
the parturient.  We hypothesize that there may be specific subgroups in which the 
parturients satisfaction is improved by the presence of a companion during labor 
epidural catheter placement; however, a significant improvement in maternal anxiety, 
when including all participants, will not be appreciated. 
 
 
BACKGROUND: 
Currently at our institution, the support team for the parturient in labor is asked to exit 
the room during the placement of the labor epidural catheter.  However, there has been 
a recent movement in many institutions to allow a companion to be present during this 
perceived stressful procedure, as it may improve maternal satisfaction and anxiety, in a 
similar fashion as having a support person present during a cesarean delivery under 
neuraxial anesthesia. 
 
There have only been two randomized controlled trials published that have investigated 
the presence of a companion during neuraxial procedures in a parturient.  The first was 
published by Orbach-Zinger et al. in Anesthesia and Analgesia (2012), investigating 84 
couples in Isreal, randomized between partner in (n=41) and partner out (n=42).  They 
investigated both partners’ anxiety utilizing the State Anxiety Inventory questionnaire 
before and after epidural placement, as well as asking the parturient to rate the pain 
associated with the epidural placement.  They found that there was actually an increase 
in anxiety when the partner was present in the room, and that the parturient perceived a 
more painful placement in this situation as well.  However, they did not evaluate 
whether the parturient wanted her partner present.  Additionally, this study did not focus 
on an American population, a population that has been described repeatedly to place 
high value on individual choice.  Iyengar and Lepper published a study in the Journal of 
Personality and Social Psychology (1999) describing the value that Americans place on 
individual choice, and showing that this value was present even in early childhood.  
Therefore, the results of a study in the United States focusing on the choice of the 
parturient may very well yield different results than those found by Orbach-Zinger et al.   
 
The second study was published earlier by Prabhu et al. in the International Journal of 
Obstetric Anesthesia (2009), and evaluated the anxiety of parturients both before and 
after the placement of neuraxial anesthesia prior to cesarean delivery.  They compared 
the anxiety level of the parturient using a VAS, and found a small improvement in 
anxiety in those parturients whose partners were present during placement.  This study 
was conducted in Ann Arbor, MI, and investigated an American population, but did not 
specifically address the choice of the parturient.  Instead, as with the first study 
mentioned, the groups were randomized to partner in versus partner out, and never 
inquired as to the preference of the parturient.  Additionally, the neuraxial procedure 
occurring in an operating suite, as opposed to a labor and delivery suite, and the 

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pending surgical intervention may have confounded the anxiety experienced by the 
parturient. 
 
During the month of August, a small, random sampling of parturients in the labor and 
delivery ward at Prentice Women’s Hospital were surveyed as to whether they would 
want a companion present during the placement of a labor epidural catheter for 
analgesia.  Those that already had a labor epidural catheter in place were asked if they 
would have liked to have a companion present during the placement, while those who 
did not yet have one placed were asked if they would choose to have someone present 
if they were given the choice.  An overwhelming number of parturients (29/34) stated 
that they would choose to have a companion present for the procedure.  Additionally, of 
those who would not have chosen to have someone present (5/34), two stated that they 
still would have appreciated being given the choice.  Our study would add to the two 
prior studies by specifically demonstrating whether giving the parturient her choice in 
the presence of a companion improves satisfaction, as well as anxiety, during the 
placement of a labor epidural catheter for analgesia. 
 
 
INCLUSION AND EXCLUSION CRITERIA: 
Parturients will be screened for eligibility on a basis of reason for admission to the labor 
and delivery ward.  Those that are being induced for labor or arrive in spontaneous 
labor will be considered.  Those admitted for a planned procedure, other than labor, will 
not be eligible. 
Companions will be approached on the labor and delivery unit 8th and 9th floor Prentice 
Women’s Hospital and the study team member will introduce the study as well as the 
requirements for participation. A verbal consent will be obtained. 
 
 
Physician Participants 
 
A) Attending Physicians will be approached on the labor and delivery unit on the 8th floor 
Prentice Women’s Hospital to participate in the study before the epidural catheter has 
been placed. Risks and benefits as well as responsibilities of completing the 
questionnaire will be discussed.   
 
B) Resident Physicians and Anesthesiology Fellows 
The resident physician or fellow will be approached on the labor and delivery unit on the 
8th floor Prentice Women’s Hospital in the Anesthesiology work room before the epidural 
catheter has been placed. Risks and benefits as well as responsibilities of completing 
the questionnaire will be discussed as well as the ability for the resident to opt out of 
study participation. 
 
Inclusion:  
Parturients will be included if they are delivering the first child and are planning to labor 
with neuraxial analgesia.  Additionally, there will need to be sufficient time before 
delivery to allow the completion of the Pre procedure questionnaire, State-Trait Anxiety 

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Inventory (STAI) questionnaire both before and after the procedure, as well as the 
Newest Vital Sign questionnaire and the Pain Catastrophizing Scale questionnaire 
before the procedure.  They will be included if they are ASA 2.  Furthermore, they be 
required to read and comprehend the English language, as the Newest Vital Sign 
questionnaire requires them to read and interpret a nutrition label. 
 
 
Physician Inclusion: 
Anesthesiology Attending, Fellow or Resident Physicians who participants in the 
placement of the epidural catheter placement 
 
Companion Inclusion: 
Primary companion identified by parturient over the age of 18 
 
Exclusion: Parturients will be excluded if they are receiving neuraxial anesthesia for a 
cesarean delivery, external cephalic version, or other non-labor procedure.  They will 
also be excluded if they begin to push for delivery before completion of the STAI 
questionnaire following labor epidural catheter placement.  They will be excluded if 
there is no support person present at the time of the neuraxial procedure.  They will be 
excluded if they are ASA 3 or greater, or if they have a contraindication to receiving any 
of the medications routinely used in the placement of a labor epidural catheter 
(lidocaine, bupivacaine, epinephrine, fentanyl).  Adults who are unable to consent and 
minors will be excluded. 
 
STUDY-WIDE NUMBER OF PARTICIPANTS: 
The total number of participants has been determined to be 75 per group, for a total of 
150. 
 
STUDY-WIDE RECRUITMENT METHODS: 
Potential participants will be recruited while they are on the labor and delivery ward at 
Prentice Women’s hospital, prior to the placement of a labor epidural catheter.  They will 
be approached by a member of the research team. 
 
Potential participants will be identified by interview and personal history, as well as by 
anesthesia and obstetric notes in the electronic medical record. 
 
No advertisements will be used to recruit participants for the study. 
 
 
MULTI-SITE RESEARCH: 
N/A 
 
STUDY TIMELINES: 
The duration of an individual’s participation extends from initial enrollment while on the 
labor and delivery ward prior to labor epidural catheter placement until the completion of 
the STAI questionnaire and survey following this procedure.  The duration of the study 
enrollment is anticipated to be 3-5 months, with the plan to enroll an average of 2-4 

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parturients daily, and accounting for study drop-outs.  The estimated date for study 
completion is late spring to early summer of 2017. 
 
 
STUDY ENDPOINTS: 
The primary endpoint for the study is: 
- 
Does having a support person present when it is the desire of the parturient has 
a positive effect on maternal satisfaction during the placement of epidural 
catheter for labor analgesia? 
The secondary endpoints are: 
- 
Does having a support person present when it is the desire of the parturient has 
a positive effect on maternal anxiety during the placement of epidural catheter for 
labor analgesia? 
- 
Does having a support person present when it is the desire of the parturient have 
a positive effect on maternal perception of pain during the placement of epidural 
catheter for labor analgesia? 
- 
Does the presence of a support person affect the perceived difficulty of the 
procedure by the provider placing the labor epidural catheter? 
- 
Does the level of health literacy of a parturient affect her level of anxiety? 
- 
Does the degree of Pain Catastrophizing affect the parturients level of anxiety? 
- 
Does the relationship of the parturient to the support person have an effect on 
the level of anxiety of the parturient? 
- 
Does the ethnicity of the parturient have an effect on the level of anxiety? 
- 
Does induction of labor versus spontaneous labor have an effect on the level of 
anxiety of the parturient? 
 
PROCEDURES INVOLVED: 
Parturients who have been admitted to the Labor and Delivery ward at Prentice 
Women’s Hospital will be approached by a member of the research team prior to the 
placement of a labor epidural catheter.  They will be asked if they are considering 
neuraxial labor analgesia, and if they are they will be screened using the inclusion and 
exclusion criteria to determine study eligibility.  Once they have been evaluated and 
found to be appropriate for the study, they will be invited to participate. 
 
Participants will be asked to fill out the STAI questionnaire to assess the level of anxiety 
prior to placement of the labor epidural catheter, and before knowing their group 
assignment. They will then complete the pre procedure questionnaire. This 
questionnaire asks about expectations she has for the labor epidural procedure.  They 
will then be given the page of the Newest Vital Signs questionnaire with the Nutrition 
Facts, and be asked the 6 questions by the recruiter.  Then they will be asked the Pain 
Catastrophizing Scale questionnaire with 13 statements, and asked to respond as 
directed by the instructions stated by the researcher.  They will then be asked who their 
primary support person is.  A form will be handed to that person to confidentially record 
if he/she would prefer to be present for the procedure.  This form will be collected from 
the support person, and without the parturient aware of the support person’s response, 
she will be asked for her preference with regard to the presence of a support person in 

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the room, which will be recorded on this form as well.  Finally, she will be asked which 
ethnicity she most relates to, also to be recorded on this form. 
 
After all these data have been collected, the parturient will be randomized as to whether 
her companion will be allowed in the room or will be asked to leave.  This will not be 
communicated to the parturient until the time of the labor epidural catheter placement.  
When she requests the neuraxial labor analgesia, the provider placing the labor epidural 
catheter will be made aware of which group she has been randomized to, and will either 
ask the companion to leave for placement, or provide the companion a non-mobile chair 
to sit on in front of the parturient for placement of the labor epidural.  The companion will 
be asked to remain in the chair.  He/she will be asked to focus on the parturient.  It will 
be emphasized that he/she must remain seated and will not be allowed to observe the 
procedure being performed.  This is to prevent loss of consciousness in the companion, 
which has been documented in the literature (Devore and Asrani, 1978; Crosby and 
Halpern, 1989).  One violation will result in a warning, and after a second the 
companion will be escorted out of the room and the participant will be removed from the 
study. 
 
The provider will place the labor epidural catheter in the regular fashion, as is common 
practice at Prentice Women’s Hospital.  After preparation and draping of the skin in the 
sitting position, infiltration with Lidocaine 1% will be conducted at L3-L4 or L4-L5. A 17g 
Tuohy needle will be advanced into the epidural space, using a loss of resistance with 
either saline or air, depending on the provider’s preference.  After the epidural space 
has been located, a 27g pencil-tip spinal needle will be placed through the Tuohy, into 
the intrathecal space, and an intrathecal dose of medication will be administered.  The 
exact dose to be injected will be left up to the discretion of the provider, who will 
determine the appropriate dose based on the patient’s situation at that time.  After the 
intrathecal dose is administered, the spinal needle will be removed and a 19g epidural 
catheter will be placed through the Tuohy into the epidural space.  It will be secured at 
the skin with a sterile dressing and tape, leaving 5cm of the catheter in the epidural 
space.  The patient will then be placed in a lateral position. 
 
After the completion of the neuraxial procedure, the study participant will be asked to 
record her overall satisfaction with the procedure, as well as her perception of pain 
during the placement of the labor epidural catheter, using two VAS from 0-100mm.  
Additionally, she will be asked to complete the STAI questionnaire again.  Finally, she 
will be asked to complete the post procedural questionnaire.  At that point the 
parturient’s participation in the study will be complete. 
 
The provider or research team member will be asked to fill out the Participant’s 
Demographics Information form. 
 
The provider placing the labor epidural catheter will be asked to evaluate his/her ability 
to palpate landmarks for placement, the positioning of the patient, and overall perceived 
difficulty with the epidural placement, using a VAS from 0-100mm for each, which will be 
kept confidential.  Additionally, they will complete a short series of questions focusing on 

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the presence of a companion for the procedure.  No identifying information from the 
provider will be recorded on this form. 
 
DATA AND SPECIMEN BANKING: 
N/A 
 
DATA AND SPECIMEN MANAGEMENT: 
Group sample sizes of 75 and 75 achieve 81% power to show a difference in means 
when there is a difference of 4.7 between the null hypothesis mean difference of 0.0 
and the actual mean difference of -4.7 at the 0.050 significance level (alpha) using a 
two-sided Mann-Whitney-Wilcoxon Test. 
 
The acquired data forms will be kept in folders with only the study ID number as an 
identifier.  These folders will be placed in a secure, locked cabinet in the Office of the 
Section of Obstetrical Anesthesiology.  Only those researchers directly analyzing these 
data will have access to the files.  Any electronic communication regarding the study will 
be conducted using the secure Northwestern email service.  Computerized data forms 
will be password protected.  Only the study ID number will be used to identify 
participants during data analysis.  The data will be stored until the completion of the 
study, including the final data analysis.  Members of the anesthesia team collecting 
these data will be educated on the process prior to approaching prospective 
participants. 
 
These data collected from each participant will include: 
- 
STAI forms before and after epidural placement 
- 
Pre and post procedure questionnaire 
- 
VAS scoring of satisfaction and pain perception following the procedure 
- 
Newest Vital Sign form completed before epidural placement 
- 
Pain Catastrophizing Score form completed before epidural placement 
- 
Relation of the support person to the parturient 
- 
Support person and parturients preference completed before epidural placement 
- 
Post procedure questionnaire from the Resident/Fellow Physician 
- 
Post procedure questionnaire from the Attending Physician 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF 
PARTICIPANTS: 
N/A 
 
WITHDRAWAL OF PARTICIPANTS: 
Participants will be withdrawn from the study if the companion is required to leave due 
to violation of directions.  These include entering the room before the procedure is 
completed if he/she is in the partner out group, getting up from the chair or attempting to 
watch the procedure after a warning in the partner in group.  When a participant 
withdraws, data collected up to that point will be retained and analyzed at the end of the 
study to determine if there is an identifying characteristic that predisposes to inability to 
follow instructions for safe participation with the epidural procedure. 

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RISKS TO PARTICIPANTS: 
Risks to the parturients participating in this study are the same risks as those electing to 
have neuraxial labor analgesia not involved in the study.  The placement of a labor 
epidural catheter includes specific risks, which are communicated to the parturient 
before obtaining informed consent for the procedure.  These include bleeding, infection, 
nerve injury, post-dural puncture headache, hypotension, fetal bradycardia, nausea, 
vomiting, and very rarely seizures and cardiac arrhythmias.  
 
There is the potential for feeling emotionally uncomfortable answering some of the 
questionnaires.  
 
There is the potential for loss of confidentiality even though there are strict measures in 
place to prevent occurrence. 
 
The risks to the companion include a vasovagal response and loss of consciousness.  
To best prevent this risk he/she will be seated in front of the parturient, unable to directly 
witness the placement of the labor epidural catheter.  Additionally, he/she will be placed 
on a seat that does not have wheels and cannot move. 
 
POTENTIAL BENEFITS TO PARTICIPANTS: 
The potential benefit to the parturient is an improvement in both satisfaction and anxiety 
during the procedure, through the presence of a familiar companion. 
 
 
VULNERABLE POPULATIONS: 
The study is designed to evaluate an intervention during labor and is therefore, by 
definition, involving pregnant women.  The study itself does not change whether 
neuraxial analgesia will be offered to an individual for labor pain.  The HRP-412 
Checklist has been reviewed and there are no conflicts noted. 
 
COMMUNITY-BASED PARTICIPATORY RESEARCH: 
N/A 
 
SHARING OF RESULTS WITH PARTICIPANTS: 
N/A 
 
SETTING: 
- The research will be conducted on the Labor and Delivery ward 8th floor at 
Prentice Women’s Hospital 
- The research team will identify and recruit potential participants on the Labor and 
Delivery ward at Prentice Women’s Hospital 
- Research procedures will be performed in the Labor Suites on the Labor and 
Delivery ward at Prentice Women’s Hospital 
- There is no plan to create a community advisory board at this time 
 

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RESOURCES AVAILABLE: 
- The labor epidural catheter placement will be conducted by a resident physician, 
fellow physician, or attending physician, who has completed sufficient training in 
neuraxial labor analgesia and deemed to be qualified to place labor epidurals by 
the Department of Obstetrical Anesthesiology at Northwestern. 
- The member of the anesthesia team recruiting the participants will be educated 
in the use of the STAI, pre and post procedure, Newest Vital Sign, and Pain 
Catastrophizing questionnaires prior to enrolling participants.  The primary 
recruitment will be by the anesthesia research nursing staff that has extensive 
experience in recruiting participants to various studies. 
- We expect to recruit 2-4 participants on a daily basis, as the number of labor 
epidural catheters placed during a given 24 hour period well exceeds 20.  By 
recruiting 1 participant every day (<5% of laboring parturients each day), or 7 in a 
week period, the data collection would take 22 weeks, which is within the 
proposed 3-5 month recruitment period. 
- This research will be conducted primarily by Feyce Peralta, M.D. and Eric Morell, 
M.D. the latter of which is the current Fellow in Obstetrical Anesthesiology and 
has 3 months of devoted time during this fellowship year for research. 
- While the collection of data will occur in the Labor Suite on the Labor and 
delivery ward, the analysis of these data collected during the study will be 
analyzed in the Office of Obstetrical Anesthesiology 9th floor Prentice as well as 
in the main Anesthesiology Office in Arkes 10th floor. These locations are 
restricted to personnel in the Department of Anesthesiology and are not located 
in patient care areas. 
- Participants will have access to the members of both the research and 
anesthesia teams on call, before and after placement of the labor epidural 
catheter, who can answer any questions they may have regarding the procedure. 
- Prior to recruiting participants, the study protocol will be reviewed by the 
anesthesia research study team. 
- The provider placing the labor epidural catheter will be informed of which group 
the parturient was randomized into just before entering the room for the 
procedure.  At that time they will either ask the companion to leave the room or 
ensure that there is a non-mobile seat for the companion in front of the parturient. 
 
PRIOR APPROVALS: 
Department of Anesthesiology Research Committee 
 
RECRUITMENT METHODS: 
Participants will be recruited on the Labor and Delivery Ward 8th floor of Prentice 
Women’s Hospital.  They will be approached regarding participation if they meet 
inclusion criteria during chart review or initial pre-anesthesia interview.  Both patients in 
spontaneous labor and those scheduled for induction of labor will be approached if they 
meet criteria.  The GE Centricity computerized board that lists all active laboring 
parturients is available in the anesthesia work room for review of the current Labor and 
Delivery census.  If the patient is nulliparous she will be approached by a member of the 

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research team with regard to enrollment in the study.  No reimbursement will be offered 
for participation. 
 
NUMBER OF LOCAL PARTICIPANTS: 
A total of 150 participants will complete the study.  Half of the participants (n=75) will be 
randomized to the “companion in the room” group and half (n=75) will be randomized to 
the “companion out of the room” group.  We are anticipating minimal patients who enroll 
to become ineligible during the study, since the total duration of enrollment is likely less 
than a couple hours, however we will attempt to recruit 180 participants in total to allow 
for a 20% drop-out rate, either by choice or by protocol violation. 
 
Resident Participation: A total of 64 participants 
 
Attending Physician: A total of 30 participants 
 
Companion: A total of 150 participants 
 
CONFIDENTIALITY: 
Data will be stored in a department server which is password protected.  Each study 
subject will be assigned a study code number. The code will be used to link study data 
to patient identification (name) in a separate database.  Subject data will be stored on 
secured password protected computers at Northwestern University and Department of 
Anesthesiology servers. Paper data will be completed by research study team members 
and will be entered into REDCap. The paper folders will be stored in Arkes Pavilion 10th 
floor Department of Anesthesiology administrative office via key card controlled front 
door and key controlled closet.  Data access will be password protected and only 
available to study investigators via REDCap. REDCap access will be controlled by the 
Principal Investigator. Data both electronic and paper will be destroyed 5 years after 
manuscript preparation. 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS: 
All parturients on the Labor and Delivery Ward at Prentice Women’s Hospital receive an 
anesthesia consultation regardless of whether they are planning to have neuraxial labor 
analgesia, in anticipation of an unplanned surgical emergency requiring intervention by 
the anesthesia team.  During the interview they are simply asked if they are planning to 
have neuraxial labor analgesia.  This does not affect the remainder of the interview, 
except to explain to the parturient the steps involved in the placement of the labor 
epidural catheter, as well as the risks and benefits.  During the study period, those 
parturients that fit the inclusion/exclusion restrictions will also be asked if they are 
interested in participating in a study that is “evaluating the impact of a companion’s 
presence during the epidural procedure.”  Regardless of their response, if they are 
interested in receiving neuraxial labor analgesia and are an appropriate candidate for 
the procedure, they will receive a labor epidural catheter.  It is rare on the Labor and 
Delivery Ward to receive a specific request of a certain level provider to place the labor 
epidural catheter, however it does happen.  As is the case currently, the best effort will 
be made to honor the request, however due to staffing and volume of patients, this is 

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not always possible.  There will be no difference in how these requests are treated in 
the study population. 
 
The research staff will have access to the patient’s EMR just as they do currently, and 
will use it in the same manner as it is currently used, to look up relative medical history 
as it relates to the patient’s current labor event and to document a pre-anesthesia 
evaluation in the patient’s chart.  The patient’s EMR will not be used in any greater 
capacity than is required to care for the patient during her labor.  After the study data 
have been collected for each participant, it will be placed in a locked file that will only be 
accessed for data analysis. 
 
COMPENSATION FOR RESEARCH-RELATED INJURY: 
N/A 
 
ECONOMIC BURDEN TO PARTICIPANTS: 
Subjects will not be paid or charged extra for the care they receive as part of this study. 
All subjects will be charged for standard care they receive including the cost of the 
epidural labor analgesia that they would receive if they had not participated in this study.  
This cost will be billed to their insurance providers. 
 
CONSENT PROCESS: 
The consent process will take place in the Labor and Delivery Unit, 8th Floor, at Prentice 
Women’s Hospital. There is no waiting period since subjects are in the hospital for 
delivery of their baby. SOP HRP 090 will be followed. The research study team will 
spend greater than 10 minutes discussing the study.  
 
The consent will be discussed in full with the parturient prior to signing.  The concept of 
randomization will be emphasized, and that although she may have a preference, this 
will not affect her grouping.   
 
Between the times that the parturient agrees to participate, up to the time of the 
neuraxial procedure, she will be invited to discuss any part of the procedure or study 
with a member of the research or anesthesia teams.  This is no different than the 
current protocol on the Labor and Delivery ward in which the parturients are invited to 
ask any questions they might have regarding the anesthesia for labor and cesarean 
delivery. 
 
Ample time will be allowed for patient to answer questions regarding the study and the 
consent document. The subject will also be informed that there is no conflict of interest 
between the PI and the protocol. The PI will not receive financial remuneration nor will 
the study participation affect the subject’s financial charges for their care. 
  
For Non-English Speaking Participants 
N/A 
 
Waiver or Alteration of Consent Process: 

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N/A 
 
Participants who are not yet adults (infants, children, teenagers) 
N/A 
 
Cognitively Impaired Adults 
N/A 
 
Adults Unable to Consent 
N/A 
 
PROCESS TO DOCUMENT CONSENT IN WRITING: 
In addition to the standard consent for anesthesia required prior to receiving neuraxial 
labor analgesia, the participants will be required to sign a consent form for participation 
in the study.  Prior to signing the study consent, they will be made aware of the 
questionnaires they will be asked to complete, as well as the randomization process 
that will be used to place them one of two groups.  The study itself involves no more 
than minimal risk to the parturient, as the procedure to be performed will be the same as 
the currently performed for neuraxial labor analgesia.  The only difference in the two 
procedures is the presence of a companion.  She will still be asked to sign a consent 
form, however, that reiterates the study, and the grounds by which her companion will 
be asked to leave during the procedure, if he/she is randomized to the “companion in” 
group. 
  
DRUGS OR DEVICES: 
N/A