Clinical trial NCT04017442
Conditions: Postpartum Pain Postpartum Depression Opioid Consumption
Keywords: Postpartum depression Postpartum anxiety Postpartum opioids
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2019-10-19; Completion date: 2023-08-31
Enrollment: 160 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients presenting for normal spontaneous vaginal delivery who have a neuraxial anesthestic will be randomized to receive preservative free morphine or saline placebo after delivery.

Detailed description:
After obtaining consent, women presenting to the labor floor at Mount Sinai Hospital will be randomized into two groups, intervention and placebo. Baseline demographic data and surveys in regards to postpartum depression, anxiety, breastfeed willingness and pain scores will be obtained. After delivery of the baby patients will either receive 2mg preservative free morphine or saline via the epidural catheter prior to its removal. The study team will then record pain and recovery scores, as well as follow up screens to the aforementioned endpoints. The study will end at the 6 week postpartum visit with the patient's obstetrician.

Arms: arm 1: 2mg preservative free morphine arm 2: 4 mL preservative free saline
Interventions: intervention 1: Preservative Free Morphine intervention 2: Saline
Intervention descriptions: intervention 1: After delivery of the baby patients will receive via the epidural catheter prior to its removal. intervention 2: After delivery of the baby patients will receive via the epidural catheter prior to its removal.

Protocol documents:
Prot_SAP_000.pdf: 
Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: 
A Prospective Double Blind Randomized Control Trial 
Duramorph Study Design: Prospective, Randomized Double Blinded
PI: Daniel Katz, MD
NCT04017442
Document Date: 1-11-2023


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Duramorph Study Design: Prospective, Randomized 
Double Blinded 
Unique Protocol Identification Number:  
National Clinical Trial (NCT) Identified Number: NCT04017442 
Principal Investigator: Daniel Katz 
IND/IDE Sponsor:  
Version Number: 1.000 
11 Jan 2023 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
Table of Contents 
 Table of Contents - Please right-click and choose 'Update Field'. 


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STATEMENT OF COMPLIANCE 
Provide a statement that the trial will be conducted in compliance with the protocol, International 
Council on Harmonisation Good Clinical Practice (ICH GCP) and applicable state, local and federal 
regulatory requirements. Each engaged institution must have a current Federal-Wide Assurance (FWA) 
issued by the Office for Human Research Protections (OHRP) and must provide this protocol and the 
associated informed consent documents and recruitment materials for review and approval by an 
appropriate Institutional Review Board (IRB) or Ethics Committee (EC) registered with OHRP. Any 
amendments to the protocol or consent materials must also be approved before implementation. Select 
one of the two statements below. If the study is an intramural NIH study, use the second statement 
below: 
1.
The trial will be carried out in accordance with International Council on Harmonisation Good
Clinical Practice (ICH GCP) and the following:
o
United States (US) Code of Federal Regulations (CFR) applicable to clinical studies (45 CFR Part
46, 21 CFR Part 50, 21 CFR Part 56, 21 CFR Part 312, and/or 21 CFR Part 812).
National Institutes of Health (NIH)-funded investigators and clinical trial site staff who are 
responsible for the conduct, management, or oversight of NIH-funded clinical trials have 
completed Human Subjects Protection and ICH GCP Training. 
OR 
2.
The trial will be conducted in accordance with International Council on Harmonisation Good
Clinical Practice (ICH GCP), applicable United States (US) Code of Federal Regulations (CFR), and
the [specify NIH Institute or Center (IC) [ Terms and Conditions of Award. The Principal
Investigator will assure that no deviation from, or changes to the protocol will take place
without prior agreement from the funding agency and documented approval from the
Institutional Review Board (IRB), and the Investigational New Drug (IND) or Investigational
Device Exemption (IDE) sponsor, if applicable, except where necessary to eliminate an
immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study
have completed Human Subjects Protection and ICH GCP Training.
For either option above, the following paragraph would be included:
The protocol, informed consent form(s), recruitment materials, and all participant materials will
be submitted to the IRB for review and approval. Approval of both the protocol and the consent
form(s) must be obtained before any participant is consented. Any amendment to the protocol
will require review and approval by the IRB before the changes are implemented to the study.
All changes to the consent form(s) will be IRB approved; a determination will be made regarding
whether a new consent needs to be obtained from participants who provided consent, using a
previously approved consent form.


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1 PROTOCOL SUMMARY 
1.1 SYNOPSIS 
Title: 
Duramorph Study Design: Prospective, Randomized Double 
Blinded  
Study Description: 
Prospective double blind randomized control trial 
Objectives: 
Primary Objective: Analyze impact of epidural morphine on pain 
management for vaginal delivery VD 
Secondary 
Objectives: 
Analyze impact of epidural morphine on 
recovery and depression 
 
Endpoints: 
Primary Endpoint: 
Opiate consumption at 24 hours 
Secondary 
Endpoints: 
Pain score at 24 hours, obstetric revoery score 
at 24 hours, ediburgh post partum depression 
scale at 6 weeks, breast feeding success at 1 
week 
Study Population: 
Pregnant women over 18 
Phase: 
4 
Description of 
Sites/Facilities Enrolling 
Participants: 
KP2 Labor floor at Mount Sinai Hospital 
Description of Study 
Intervention: 
Epidural morphine 2mg vs placebo 
Study Duration: 
4 years 
Participant Duration: 
6 weeks 
  
 
 
1.2 SCHEMA 
1. Obtain consent 
2. 1 hour delivery administer study drug or placebo 
3. 24 hours after collect data on opiate administration, pain score, and recovery score 
4. 1 week after administration call patient inquire about breast feeding 
5. At 6 weeks after administration call patient and administer post partum depression screen 


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1.3 SCHEDULE OF ACTIVITIES (SOA) 
1. Obtain consent 
2. 1 hour delivery administer study drug or placebo 
3. 24 hours after collect data on opiate administration, pain score, and recovery score 
4. 1 week after administration call patient inquire about breast feeding 
5. At 6 weeks after administration call patient and administer post partum depression screen 
 
 


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2 INTRODUCTION 
2.1 STUDY RATIONALE 
There is no current standard of care for post vaginal delivery pain. Many different options exist, 
however, their impact on minimizing opiate utilization have been minimal. As such, we are investigating 
the utility of a single dose of preservative free morphine on pain scores in the post partum period. 
 
 
2.2 BACKGROUND 
There is no gold standard for pain management in NSVD. There is some evidence that preservative free 
morphine is effective at pain relief for cesarean deliveries. The relationship between pain and epidural 
morphine for NSVD has not been investigated. 
 
 
2.3 RISK/BENEFIT ASSESSMENT 
  
2.3.1 KNOWN POTENTIAL RISKS 
Risks can include nausea, vomiting, itching, respiratory depression 
  
2.3.3 ASSESSMENT OF POTENTIAL RISKS AND BENEFITS 
Benefits include less oral and IV opiate use which also cause nausea, itching and respiratory depression. 
Benefits may also include a faster recovery and more breast feeding. The risks of this dose of morphine 
are small and have been used for cesarean delivery for decades. 
 
 


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3 OBJECTIVES AND ENDPOINTS 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
  
Opiate consumption at 24 hours 
Opiate use should be 
minimized due to side 
effects 
Secondary 
  
Pain score at 24 hours 
Recovery score at 24 hours 
Breast feeding rate at 1 week 
Post partum depression screen at 6 
weeks 
Better pain control is good 
endpoint, as is recovery. 
Breastfeeding can have long 
term impacts on both mom 
and baby and it's impact 
should be investigated. 
Depression is a major issue 
post partum and controlling 
pain in the immediate post 
partum period may help 
with that. 
Tertiary/Exploratory 
  
  
  


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4 STUDY DESIGN 
4.1 OVERALL DESIGN 
Double blind, prospective, randomized control trial 
 
 
4.2 SCIENTIFIC RATIONALE FOR STUDY DESIGN 
When investigating the impact of a medication on pain, opiate consumption, etc, it is important for the 
study to be blinded and randomized to avoid bias. 
 
 
4.3 JUSTIFICATION FOR DOSE 
This dose is commonly administered to pregnant women for cesarean delivery. It has an excellent safety 
profile and a long history of use. 
 
 
4.4 END OF STUDY DEFINITION 
Patients complete their involvement after their 6 weeks post partum depression screen 
 
 


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5 STUDY POPULATION 
5.1 INCLUSION CRITERIA 
18 years old, pregnant, presenting for VD 
 
 
5.2 EXCLUSION CRITERIA 
Refusal of neuraxial anesthesia, allergy to morphine, patients with chronic pain syndromes or chronic 
opiate use. 
 
 
5.3 LIFESTYLE CONSIDERATIONS 
Not applicable for this study. 
 
 
5.4 SCREEN FAILURES 
Patients are consented when they have adequate pain control and are in labor. Due to patient 
convenience patients may consent to participate but not be randomized based on their time of delivery. 
These patients will be kept in a separate log. 
 
 
5.5 STRATEGIES FOR RECRUITMENT AND RETENTION 
We will use the clinical anesthesia team to inform us of potential patients. They have been educated 
about the study.  
 
 


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6 STUDY INTERVENTION 
6.1 STUDY INTERVENTION(S) ADMINISTRATION 
6.1.1 STUDY INTERVENTION DESCRIPTION 
Epidural morphine 2mg  
6.1.2 DOSING AND ADMINISTRATION 
  
2 mg (4ml) will be administered one hour after the patient has their VD. It will be administered through 
their in situ epidural 
 
 
6.2 PREPARATION/HANDLING/STORAGE/ACCOUNTABILITY 
  
6.2.1 ACQUISITION AND ACCOUNTABILITY 
Investigational Drug Service stocks the Pyxis machine with the study drug. it uses real time automated 
biometric safety protocols to ensure only those able to administer the study drug are allowed to remove 
it 
6.2.2 FORMULATION, APPEARANCE, PACKAGING, AND LABELING 
PI attached to IRB application. it is a brown ampule with 10mg total in the vial. 
6.2.3 PRODUCT STORAGE AND STABILITY 
It is stored in the Pyxis machine as per requirements 
6.2.4 PREPARATION 
After removal from the Pyxis machine the study drug is steriley drawn up into a syringe and labeled 
"study drug". This is then handed off to a different member of the study team to administer. The 
remainder is returned to the drug lockbox as per protocol 
 
 
6.3 MEASURES TO MINIMIZE BIAS: RANDOMIZATION AND BLINDING 
All patients presenting for VD are eligible and the clinical teams are trained in implicit bias and have had 
special education from the research team for this study. Given the randomization we cannot demand 


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that any specific group be targeted for recruitment. We want an equitable and balanced sample for our 
study. 
 
 
6.4 STUDY INTERVENTION COMPLIANCE 
Each step is recorded in either the datasheets or Pyxis logs. After the administration all that remains is 
data collection from the patients. Given that we contact patients at the required times we expect a high 
level of compliance. 
 
 
6.5 CONCOMITANT THERAPY 
  
6.5.1 RESCUE MEDICINE 
Any patients on opiates or with an allergy to morphine are excluded and as such there is no risk for 
synergistic effects of the study drug. As per our CD protocol, we provide the same rescue doses of 
medications for morphine including ondanstetron, diphenhydramine, and nalxone all as needed. 
 
 


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7 STUDY INTERVENTION DISCONTINUATION AND PARTICIPANT 
DISCONTINUATION/WITHDRAWAL 
7.1 DISCONTINUATION OF STUDY INTERVENTION 
Should we experience any cases of respiratory depression we will stop the study and review the case.  
 
 
7.2 PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Participants may withdraw from the study at any time by notifying the study team and/or the PI either 
verbally or in written form. 
 
 
7.3 LOST TO FOLLOW-UP 
Given that one of our endpoints is 6 weeks out we expect to loose some patients to follow up. This will 
impact our findings, however, our study is powered for our primary endpoint which is opiate 
consumption at 24 hours. We expect little or no followup loss for this endpoint. 
 
 


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8 STUDY ASSESSMENTS AND PROCEDURES 
8.1 EFFICACY ASSESSMENTS 
At 24 hours we will get a likert pain score, as well as a recovery score. We will also obtain opiate 
consumption for this time. 
  
 
 
8.2 SAFETY AND OTHER ASSESSMENTS 
At one week we will ask patients about breast feeding. At 6 weeks we will ask about depression 
 
 
8.3 ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
  
8.3.1 DEFINITION OF ADVERSE EVENTS (AE) 
Adverse events include nausea and itching 
8.3.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE) 
Serious adverse event would be respiratory depression requiring naloxone administration 
8.3.3 CLASSIFICATION OF AN ADVERSE EVENT 
Classification of an adverse event is based on symptomatology type as described above. 
8.3.3.1 SEVERITY OF EVENT 
As above, severity is determined by need to administer rescue medications and type. 
8.3.3.2 RELATIONSHIP TO STUDY INTERVENTION 
We will examine each case and determine relationship to the study intervention. 
8.3.3.3 EXPECTEDNESS 
We expect to have cases of nausea and itching, we anticipate no cases of respiratory depression 
8.3.4 TIME PERIOD AND FREQUENCY FOR EVENT ASSESSMENT AND FOLLOW-UP 
Patients are monitored according to post partum protocols. The areas the patients recover are all 
equipped to manage patients after receiving neuraxial morphine. 


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8.3.5 ADVERSE EVENT REPORTING 
We receive reports from patients about their AEs on follow up or from the clinical team if they bring it 
up. 
8.3.6 SERIOUS ADVERSE EVENT REPORTING 
All patients are monitored for respiratory depression. All cases of this are reported to our internal PI 
committee and reviewed independently.  
8.3.7 REPORTING EVENTS TO PARTICIPANTS 
All AEs are reported to participants. 
8.3.8 EVENTS OF SPECIAL INTEREST 
N/A 
8.3.9 REPORTING OF PREGNANCY 
N/A 
 
 
8.4 UNANTICIPATED PROBLEMS 
  
8.4.1 DEFINITION OF UNANTICIPATED PROBLEMS (UP) 
There are no unanticipated problems with this study, however, should any issue occur the PI will be 
available to discuss 
8.4.2 UNANTICIPATED PROBLEM REPORTING 
At any time any participant, clinical team member, or study team member can report and event to the 
PI. 
8.4.3 REPORTING UNANTICIPATED PROBLEMS TO PARTICIPANTS 
Those that may impact patient care and well being will be reported to all participants. 
 
 


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9 STATISTICAL CONSIDERATIONS 
9.1 STATISTICAL HYPOTHESES 
 
Primary Efficacy Endpoint(s): 
Opiate consumption at 24 hours (Wilcoxon Rank Sum) 
 
Secondary Efficacy Endpoint(s): 
Recovery score at 24 Hours (Wilcoxon Rank Sum) 
Breast feeding at 1 week (Chi Square) 
Depression screen at 6 weeks (Wilcoxon Rank Sum) 
 
 
9.2 SAMPLE SIZE DETERMINATION 
Based on other works it was determined that for a 25% reduction in opiate utilization we needed 60 
patients for each group. To account for drop off we will recruit 150 patients per group for a total of 300 
patients 
 
 
9.3 POPULATIONS FOR ANALYSES 
This will be intention to treat for all randomized participants. 
 
 
9.4 STATISTICAL ANALYSES 
  
9.4.1 GENERAL APPROACH 
Wilcoxon rank sum for continous variables, chi square for categorical 
9.4.2 ANALYSIS OF THE PRIMARY EFFICACY ENDPOINT(S) 
Wilcoxon rank sum 
9.4.3 ANALYSIS OF THE SECONDARY ENDPOINT(S) 
Recovery score and depression score: Wilcoxon Rank Sum, Breast feeding: Chi square 


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9.4.4 SAFETY ANALYSES 
N/A 
9.4.5 BASELINE DESCRIPTIVE STATISTICS 
Given randomization we will simply report, not anlayze 
9.4.6 PLANNED INTERIM ANALYSES 
N/A 
9.4.7 SUB-GROUP ANALYSES 
N/A 
9.4.8 TABULATION OF INDIVIDUAL PARTICIPANT DATA 
Will be performed using secured encrypted software (RedCap) and SPSS software 
9.4.9 EXPLORATORY ANALYSES 
Not applicable 
 
 


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10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
  
10.1.1 INFORMED CONSENT PROCESS 
After the patient is comfortable from their epidural the clinical team will get assent for the research 
team to approach the patient. The research team will then consent the patient using standardized 
process in compliance with IRB protocols 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
N/A 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
As per IRB standard protocol 
10.1.2 STUDY DISCONTINUATION AND CLOSURE 
Upon notification of withdrawal participants can either elect to have their data destroyed, or allow the 
research team to analyze data obtained. 
10.1.3 CONFIDENTIALITY AND PRIVACY 
All data is gathered via a study ID with a linking code. ONLY the PI has access to the code which is stored 
in a locked office on a locked computer that is password protected and encrypted. As such the 
information is de-identified. 
10.1.4 FUTURE USE OF STORED SPECIMENS AND DATA 
N/A 
10.1.5 KEY ROLES AND STUDY GOVERNANCE 
Principal Investigator 
Medical Monitor 
Daniel Katz 
  
daniel.katz@mountsinai.org 
  
732-322-6675 
  
1 Gustave L Levy Place Box 1010 
  
KCC 8th Floor NY, NY 10029 
  
  
10.1.6 SAFETY OVERSIGHT 
The PI will examine all cases of AE and SAE  


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10.1.7 CLINICAL MONITORING 
All patients are monitored as per hospital protocols. 
10.1.8 QUALITY ASSURANCE AND QUALITY CONTROL 
The PI will handle all study related issues in regards to QA and QI Except for respiratory depression 
events. These will be investigated by the departmental QI committee. 
10.1.9 DATA HANDLING AND RECORD KEEPING 
10.1.9.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES 
All data are collected on de-identified forms. These are then put into a de-identified Redcap secured 
database. The PI will review records on an ad hoc basis for completeness and accuracy.  
  
  
10.1.9.2 STUDY RECORDS RETENTION 
Will be kept for 5 years after completion and then destroyed 
10.1.10 PROTOCOL DEVIATIONS 
  
10.1.11 PUBLICATION AND DATA SHARING POLICY 
We will not be sharing individual results with patients, however, we will publish our results in a medical 
journal. 
  
10.1.12 CONFLICT OF INTEREST POLICY 
As per the FCOI office of our institution 
 
 
10.2 ADDITIONAL CONSIDERATIONS 
N/A 
 
 
10.3 ABBREVIATIONS 
AE 
Adverse Event 
ANCOVA Analysis of Covariance 


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CFR 
Code of Federal Regulations 
CLIA 
Clinical Laboratory Improvement Amendments 
CMP 
Clinical Monitoring Plan 
COC 
Certificate of Confidentiality 
CONSORT Consolidated Standards of Reporting Trials 
CRF 
Case Report Form 
DCC 
Data Coordinating Center 
DHHS 
Department of Health and Human Services 
DSMB 
Data Safety Monitoring Board 
DRE 
Disease-Related Event 
EC 
Ethics Committee 
eCRF 
Electronic Case Report Forms 
FDA 
Food and Drug Administration 
FDAAA 
Food and Drug Administration Amendments Act of 2007 
FFR 
Federal Financial Report 
GCP 
Good Clinical Practice 
GLP 
Good Laboratory Practices 
GMP 
Good Manufacturing Practices 
GWAS 
Genome-Wide Association Studies 
HIPAA 
Health Insurance Portability and Accountability Act 
IB 
Investigator’s Brochure 
ICH 
International Conference on Harmonisation 
ICMJE 
International Committee of Medical Journal Editors 
IDE 
Investigational Device Exemption 
IND 
Investigational New Drug Application 
IRB 
Institutional Review Board 
ISM 
Independent Safety Monitor 
ISO 
International Organization for Standardization 
ITT 
Intention-To-Treat 
LSMEANS Least-squares Means 
MedDRA Medical Dictionary for Regulatory Activities 
MOP 
Manual of Procedures 
MSDS 
Material Safety Data Sheet 
NCT 
National Clinical Trial 
NIH 
National Institutes of Health 
NIH IC 
NIH Institute or Center 
OHRP 
Office for Human Research Protections 
PI 
Principal Investigator 
QA 
Quality Assurance 
QC 
Quality Control 


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SAE 
Serious Adverse Event 
SAP 
Statistical Analysis Plan 
SMC 
Safety Monitoring Committee 
SOA 
Schedule of Activities 
SOC 
System Organ Class 
SOP 
Standard Operating Procedure 
UP 
Unanticipated Problem 
US 
United States 
 
 
10.4 PROTOCOL AMENDMENT HISTORY 
Version 
Date 
Description of Change  
Brief Rationale 
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  
  


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11 REFERENCES 

ICF_001.pdf: 
Neuraxial Preservative Free Morphine for Normal Spontaneous Vaginal Delivery: 
A Prospective Double Blind Randomized Control Trial 
PI: Daniel Katz, MD
NCT04017442
Document Date: 1-30-2019


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
Icahn School of Medicine at Mount Sinai,  
Page 1 of 10 
Form Version Date: 1/30/2019 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev 1.16.19 
____________________________ 
STUDY INFORMATION: 
Study Title: Does epidural morphine decrease opioid requirements in post-spontaneous vaginal 
deliveries? 
Principal Investigator (Head Researcher): Daniel Katz, MD 
Physical Address: 1 Gustave I Levy Place KCC 8th floor New York, NY 10029 
Mailing Address: 1 Gustave I Levy Place Box 1010 KCC 8th floor New York, NY 10029 
Phone: 212-241-1518 
____________________________ 
SUMMARY OF THIS RESEARCH STUDY: 
In medicine there are many unanswered questions. A research study is when scientists try to answer a 
question about something that we don’t know enough about.  Participation in a research study may or 
may not directly help you or others. Participation is entirely voluntary. It is completely up to you whether 
or not you take part. You can also change your mind at any time and it will not affect your ability to get 
medical care within the Mount Sinai Health System.   
The purpose of this research study is to investigate whether or not epidural morphine will decrease 
opioid use after vaginal deliveries. This is important because decreasing opioid usage may benefit 
subjects in terms of reducing addiction potential as well as decreasing the frequency of adverse opioid 
side effects such as changes in breathing or mental status that may accompany these drugs.  
Epidural morphine (pain medication injected into the spine) is an opioid that has been used safely in 
pregnant subjects for cesarean delivery (delivery by operation). In this study, we hope to find if the post-
delivery opioid use will decrease after receiving epidural morphine within 1 hour of delivery.  
Data currently exists suggesting that epidural morphine may also be used in spontaneous vaginal 
delivery with good result. However, there is no current agreement or gold standard on pain 
management strategies for spontaneous vaginal deliveries (regular non-operative delivery). There is 
limited data investigating the use of epidural morphine and its effect on pain and depression after 
delivery.   
If you choose to participate, you will be asked to 
1) Deliver your baby at Mount Sinai Medical Center.
2) Going to your normal 6 week post-delivery check up. The data collected will be stored in our
internal database. You will not be responsible for bringing any data to your follow up visit. We
will administer a survey at this visit asking you about your mood since your delivery.
3) Answering a survey about your post-delivery satisfaction scores.


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
Icahn School of Medicine at Mount Sinai,  
 
Page 2 of 10 
 
 
 
 
 
 
Form Version Date: 1/30/2019 
 
---------------------------------------------------------FOR IRB USE ONLY-------------------------------------------------------------- 
Rev 1.16.19 
By enrolling in this study, your epidural placement and delivery will be carried out as planned by you 
and your provider at Mount Sinai. As a member of this study, you will be randomized (assigned 
by random chance, like the flip of a coin) to receive either:  
1. 2.0  mg of preservative free epidural morphine in addition to standard care of an epidural 
containing bupivacaine 0.0625% and fentanyl 2 mcg/mL during delivery, or  
2. standard care (normal Mount Sinai process outside of this research study) (preservative free 
saline injection with an epidural containing bupivacaine 0.0625% and fentanyl 2 mcg/mL) 
during delivery. The saline injection is the placebo drug.  
3. You will have an equal chance of being given each study treatment. Your anesthesiologist will 
be given a syringe containing either preservative free saline or morphine and will administer 
this upon delivery.  
 
There is no cost to you for participating. There will be no compensation involved.  
 
Using morphine in the obstetric population has been previously described to be well‐tolerated, with 
minimal risks, and is considered part of standard protocol for obstetric subjects undergoing cesarean 
delivery. If used as instructed, the risks are minimal. Like other opioids, morphine can have side effects 
including nausea, vomiting, constipation, drowsiness, or sweating. These side effects can be treated 
with medications and are usually minimal. These side effects are no different than any other opioids 
that are offered with standard of care. The risks of epidural placement are minimal and can include a 
drop in blood pressure, infection, and bleeding.  
 
Risk of the loss of private information; this risk always exists. However there are procedures in place to 
minimize this risk.  
 
You may benefit from participation in this research if you are selected to receive the study drug by 
decreasing your post-delivery pain medication requirements. You may also have a less-painful post 
delivery if you are selected to receive the study drug.  
 
Your participation will help us gain knowledge about the use of epidural morphine and its effect on 
treating pain after vaginal deliveries.  
 
Instead of participating in this research, you may elect to choose to have the current standard of care. 
You will not receive an epidural morphine injection if you choose this option.  
 
If you are interested in learning more about this study, please continue to read below. 
 
____________________________ 
PARTICIPATION IN THIS RESEARCH STUDY: 
This research study will be fully explained to you by a member of the study team. Feel free to ask all 
the questions you want before you make a decision about whether or not to participate.  Any new 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
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information that develops during this research study that might make you change your mind about 
participating will be given to you promptly. 
 
You may qualify to take part in this research study because you are a subject who will be receiving an 
epidural for a possible spontaneous vaginal delivery.  
 
 
Funds for conducting this research are provided by The Mount Sinai Hospital 
 
____________________________ 
LENGTH OF TIME AND NUMBER OF PEOPLE EXPECTED TO PARTICIPATE: 
Your participation in this research study is expected to last expected to last six weeks from your epidural 
placement.  
 
The number of people expected to take part in this research study at The Mount Sinai Hospital is 300.  
 
____________________________ 
DESCRIPTION OF WHAT’S INVOLVED: 
If you choose to participate, you will be asked to  
1) Deliver your baby at Mount Sinai Medical Center. 
2) Go to your normal 6 week post-delivery check up. The data collected will be stored in our 
internal database. You will not be responsible for bringing any data to your follow up visit.  
3) Answering a survey about your post-delivery satisfaction scores.  
 
By enrolling in this study, your epidural placement and delivery will be carried out as planned by you 
and your provider at Mount Sinai. As a member of this study, you will be randomized (assigned 
by random chance, like the flip of a coin) to receive either: 
 
1. 2.0  mg of preservative free epidural morphine in addition to standard care of an epidural 
containing bupivacaine 0.0625% and fentanyl 2 mcg/mL during delivery, or  
2. Standard care (normal Mount Sinai process outside of this research study) (preservative 
free saline injection with an epidural containing bupivacaine 0.0625% and fentanyl 2 
mcg/mL) during delivery. The saline injection is the placebo drug.  
 
You will have an equal chance of being given each study treatment. Your anesthesiologist will be 
given a syringe containing either preservative free saline or morphine and will administer this upon 
delivery. Neither you nor the study doctor will know which experimental study treatment you are 
getting; however, this information could be obtained in an emergency.   
 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
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These drugs will be administered at the time of delivery. Afterwards we will monitor your clinical 
progress until 6 weeks after delivery.  
 
There is no cost to you for participating. There will be no compensation involved.  
 
Because this project involves the use of medications or a medical device, it is necessary that we make 
a note of your participation in the electronic medical record. That way anyone treating you will be aware 
of your participation and may be able to avoid any unfortunate outcomes that could arise if your research 
participation were unknown. 
 
____________________________ 
USE OF YOUR DATA AND/OR SPECIMENS: 
In the future, your identifiable information may be removed from the private information and/or 
samples that are collected as part of this research. After this removal, the information and/or samples 
could be used for future research studies or shared with other research teams for future research 
studies. You will not be informed of the details of specific research that is done with your medical 
information and biospecimens. That means that a research project might be done that you would not 
consent to if provided with the details of that research project.   
 
_________________________ 
YOUR RESPONSIBILITIES IF YOU TAKE PART IN THIS RESEARCH: 
If you decide to take part in this research study you will be responsible for the following things:  
 
 
1) Deliver your baby at Mount Sinai Medical Center. 
2) Going to your normal 6 week post-delivery check up. The data collected will be stored in our 
internal database. You will not be responsible for bringing any data to your follow up visit.  
3) Answering a survey about your post-delivery satisfaction scores.  
 
 
____________________________ 
COSTS OR PAYMENTS THAT MAY RESULT FROM PARTICIPATION: 
You will not be paid for participating in this research study. Being in this research study will not lead to 
extra costs to you.  
____________________________ 
POSSIBLE BENEFITS: 
It is important to know that you may not get any benefit from taking part in this research.  Others may 
not benefit either.  However, possible benefits may be a decrease of your post-delivery pain medication 
requirements. You may also have a less-painful delivery if you are selected to receive the study drug.  


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
Icahn School of Medicine at Mount Sinai,  
 
Page 5 of 10 
 
 
 
 
 
 
Form Version Date: 1/30/2019 
 
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Rev 1.16.19 
 
____________________________ 
REASONABLY FORESEEABLE RISKS AND DISCOMFORTS: 
Using morphine in the pregnant population has been previously described to be well‐tolerated, with 
minimal risks, and is considered part of standard protocol for obstetric subjects undergoing cesarean 
delivery. If used as instructed, the risks are minimal. Like other opioids, morphine can have side effects 
including nausea, vomiting, constipation, drowsiness, or sweating. These side effects can be treated 
with medications and are usually minimal. These side effects are no different than any other opioids 
that are offered with standard of care. The risks of epidural placement are minimal and can include a 
drop in blood pressure, infection, and bleeding.  
 
Risk of the loss of private information; this risk always exists. However there are procedures in place to 
minimize this risk.  
____________________________ 
OTHER POSSIBLE OPTIONS TO CONSIDER: 
You may decide not to take part in this research study without any penalty.  The choice is totally up to 
you. Instead of participating in this research, you may elect to choose to have the current standard of 
care. You will not receive an epidural morphine injection if you choose this option.  
____________________________ 
IN CASE OF INJURY DURING THIS RESEARCH STUDY: 
If you believe that you have suffered an injury related to this research as a participant in this study, you 
should contact the Principal Investigator.  
 
____________________________ 
ENDING PARTICIPATION IN THE RESEARCH STUDY: 
 
You may stop taking part in this research study at any time without any penalty. This will not affect your 
ability to receive medical care at any of the Mount Sinai Health System hospitals or to receive any 
benefits to which you are otherwise entitled. 
 
If you decide to stop being in the research study, please contact the Principal Investigator or the 
research staff.   
 
If you stop being in the research study, already collected information may not be removed from the 
research study database and will continue to be used to complete the research analysis. You may be 
asked whether the investigator can collect information from your routine medical care. If you agree, 
this data will be handled in the same manner as all other research data. You may also withdraw your 
permission for the use and disclosure of any of your protected information for research, but you must 
do so in writing to the Principal Investigator at the address on the first page. Even if you withdraw your 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
Icahn School of Medicine at Mount Sinai,  
 
Page 6 of 10 
 
 
 
 
 
 
Form Version Date: 1/30/2019 
 
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Rev 1.16.19 
permission, the Principal Investigator for the research study may still use the information that was 
already collected if that information is necessary to complete the research study. Your health 
information may still be used or shared after you withdraw your authorization if you have an adverse 
event (a bad effect) from participating in the research study.  
 
Withdrawal without your consent: The study doctor, the sponsor or the institution may stop your 
involvement in this research study at any time without your consent. This may be because the 
research study is being stopped, the instructions of the study team have not been followed, the 
investigator believes it is in your best interest, or for any other reason. If specimens or data have 
been stored as part of the research study, they too can be destroyed without your consent. 
____________________________ 
CONTACT INFORMATION: 
If you have any questions, concerns, or complaints at any time about this research, or you think the 
research has harmed you, please contact Dr. Daniel Katz at 212-241-1518 
 
This research has been reviewed and approved by an Institutional Review Board. You may reach a 
representative of the Program for Protection of Human Subjects at the Icahn School of Medicine at 
Mount Sinai at telephone number (212) 824-8200 during standard work hours for any of the reasons 
listed below. This office will direct your call to the right person within the Mount Sinai Health System: 
 
Your questions, concerns, or complaints are not being answered by the research team. 
 
You cannot reach the research team. 
 
You are not comfortable talking to the research team. 
 
You have questions about your rights as a research subject. 
 
You want to get information or provide input about this research. 
 
____________________________ 
DISCLOSURE OF FINANCIAL INTERESTS: 
Sometimes, physicians/researchers receive payments for consulting or similar work performed for 
industry.  Effective September 2014 Mount Sinai reviews only payments to an individual totaling more 
than $5,000 a year per entity when determining potential conflicts of interest.  If you have questions 
regarding industry relationships, we encourage you to talk your physician/researcher or visit our website 
at http://icahn.mssm.edu/ where Mount Sinai publicly discloses the industry relationships of our faculty.  
____________________________ 
MAINTAINING CONFIDENTIALITY – HIPAA AUTHORIZATION: 
As you take part in this research project it will be necessary for the research team and others to use 
and share some of your private protected health information. Consistent with the federal Health 
Insurance Portability and Accountability Act (HIPAA), we are asking your permission to receive, use 
and share that information. 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
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Page 7 of 10 
 
 
 
 
 
 
Form Version Date: 1/30/2019 
 
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Rev 1.16.19 
What protected health information is collected and used in this study, and might also be shared with 
others? 
 
As part of this research project, the research team at the hospital(s) involved in the research will 
collect your Name, Address, Telephone number, and dates directly related to you or your baby (birth, 
admission, discharge, medical record numbers). The researchers will also get information from your 
medical record at Mount Sinai Medical Center. During the study the researchers will gather 
information by: 
1. Taking a medical history (includes current and past medications or therapies, illnesses, 
conditions or symptoms, family medical history, allergies, etc.) 
2. Reviewing obstetrical records (including current and past prenatal care records, including 
bloodwork, any hospitalizations at Mount Sinai or other hospital, fetal monitoring results, and 
ultrasound reports. 
3.  Reviewing delivery information including gestational age at delivery, opioid use, maternal 
satisfaction scores, mode of delivery (cesarean section or vaginal delivery), delivery or 
pregnancy complications, outcome of the baby. 
 
The researchers will also get information from your medical record through our electronic medical record 
system.  
 
Why is your protected health information being used? 
Your personal contact information is important to be able to contact you during the study. Your health 
information and the results of any tests and procedures being collected as part of this research study 
will be used for the purpose of this study as explained earlier in this consent form. The results of this 
study could be published or presented at scientific meetings, lectures, or other events, but would not 
include any information that would let others know who you are, unless you give separate permission 
to do so. 
 
The Principal Investigator may also use and share the results of these tests and procedures to treat you 
in collaboration with others in the Mount Sinai Health System.  
 
The research team and other authorized members of The Mount Sinai Health System (“Mount Sinai”) 
workforce may use and share your information to ensure that the research meets legal, institutional or 
accreditation requirements. For example, the School’s Program for the Protection of Human Subjects 
is responsible for overseeing research on human subjects, and may need to see your information. If 
you receive any payments for taking part in this study, the Mount Sinai Finance Department may need 
your name, address, social security number, payment amount, and related information for tax reporting 
purposes.  If the research team uncovers abuse, neglect, or reportable diseases, this information may 
be disclosed to appropriate authorities.  
 
Who, outside Mount Sinai, might receive your protected health information? 
As part of the study, the Principal Investigator, study team and others in the Mount Sinai workforce 
may disclose your protected health information, including the results of the research study tests and 
procedures, to the following people or organizations: (It is possible that there may be changes to the 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
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list during this research study; you may request an up‐to‐date list at any time by contacting the 
Principal Investigator) 
1. United States Department of Health and Human Services and the Office of Human Research 
Protection may be interested in the results of this research. 
 
In all disclosures outside of Mount Sinai, you will not be identified by name, social security number, 
address, telephone number, or any other direct personal identifier unless disclosure of the direct 
identifier is required by law. In records and information disclosed outside of Mount Sinai School of 
Medicine and Mount Sinai Hospital, you will be assigned a unique code number. The Principal 
Investigator will ensure that the key to the code will be kept in a locked file, or will be securely stored 
electronically. The code will not be used to link the information back to you without your permission, 
unless the law requires it, or rarely if the Institutional Review Board allows it after determining that 
there would be minimal risk to your privacy. It is possible that a sponsor or their representatives, a 
data coordinating office, a contract research organization, will come to inspect your records. Even if 
those records are identifiable when inspected, the information leaving the institution will be stripped 
of direct identifiers. 
 
Additionally, when applicable, the monitors, auditors, the IRB, the Office of Human Subjects 
Protection (OHRP) of the Department of Health and Human Services as well as the Food and Drug 
Administration (FDA) will be granted direct access to your medical records for verification of the 
research procedures and data. OHRP and FDA are authorized to remove information with identifiers if 
necessary to complete their task. By signing this document you are authorizing this access. We may 
publish the results of this research. However, we will keep your name and other identifying 
information confidential. 
 
For how long will Mount Sinai be able to use or disclose your protected health information?  
Your authorization for use of your protected health information for this specific study does not 
expire. 
 
Will you be able to access your records? 
During your participation in this study, you will have access to your medical record and any study 
information that is part of that record. The investigator is not required to release to you research 
information that is not part of your medical record. 
 
Do you need to give us permission to obtain, use or share your health information? 
NO! If you decide not to let us obtain, use or share your health information you should not sign this 
form, and you will not be allowed to volunteer in the research study. If you do not sign, it will not 
affect your treatment, payment or enrollment in any health plans or affect your eligibility for 
benefits. 
 
Can you change your mind? 
You may withdraw your permission for the use and disclosure of any of your protected information 
for research, but you must do so in writing to the Principal Investigator at the address on the first 
page. Even if you withdraw your permission, the Principal Investigator for the research study may still 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
Icahn School of Medicine at Mount Sinai,  
 
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Form Version Date: 1/30/2019 
 
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Rev 1.16.19 
use your protected information that was already collected if that information is necessary to 
complete the study. Your health information may still be used or shared after you withdraw your 
authorization if you should have an adverse event (a bad effect) from being in the study. If you 
withdraw your permission to use your protected health information for research that means you will 
also be withdrawn from the research study, but standard medical care and any other benefits to 
which you are entitled will not be affected. You can also tell us you want to withdraw from the 
research study at any time without canceling the Authorization to use your data. 
 
If you have not already received it, you will also be given The Hospital’s Notice of Privacy Practices 
that contains more information about how The Hospital uses and discloses your protected health 
information. 
 
It is important for you to understand that once information is disclosed to others outside Mount 
Sinai, the information may be re‐disclosed and will no longer be covered by the federal privacy 
protection regulations. However, even if your information will no longer be protected by federal 
regulations, where possible, Mount Sinai has entered into agreements with those who will receive 
your information to continue to protect your confidentiality. 
 
If as part of this research project your medical records are being reviewed, or a medical history is 
being taken, it is possible that HIV‐related information may be revealed to the researchers. If that is 
the case, the information in the following box concerns you. If this research does not involve any 
review of medical records or questions about your medical history or conditions, then the following 
section may be ignored. 
_________________________________________________________________________________ 
Notice Concerning HIV-Related Information 
If you are authorizing the release of HIV-related information, you should be aware that the recipient(s) is 
(are) prohibited from re-disclosing any HIV-related information without your authorization unless permitted 
to do so under federal or state law.  You also have a right to request a list of people who may receive or use 
your HIV-related information without authorization.  If you experience discrimination because of the release 
or disclosure of HIV-related information, you may contact the New York State Division of Human Rights at 
(888) 392-3644 or the New York City Commission on Human Rights at (212) 306-5070.  These agencies 
are responsible for protecting your rights. 
_____________________________________________________________________________________ 
 
 
 


THE MOUNT SINAI HEALTH SYSTEM 
CONSENT FORM TO VOLUNTEER IN A RESEARCH STUDY 
AND AUTHORIZATION FOR USE AND DISCLOSURE OF MEDICAL INFORMATION 
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ADULT PARTICIPANT: 
Your signature below documents your permission to take part in this research and to the use and 
disclosure of your protected health information. A signed and dated copy will be given to you. 
 
 
_________________________ 
_________________________ 
__________ __________ 
 
Signature of subject  
 
Printed Name of Subject 
 
Date 
 
Time 
 
PERSON EXPLAINING STUDY AND OBTAINING CONSENT: 
 
 
 
_________________________ 
_________________________ 
__________ __________ 
 
Signature of consent delegate 
Printed Name of consent delegate 
Date 
 
Time 
 
 
WITNESS SECTION: 
When a witness is required to observe the consent process, it should be documented below (for 
example, when subject is illiterate, visually impaired, or this document accompanies a short form 
consent). 
 
My signature below documents that the information in the consent document and any other written 
information was accurately explained to, and apparently understood by, the subject, and that consent 
was freely given by the subject. 
 
 
 
_________________________ 
_________________________ 
__________ __________ 
 
Signature of Witness  
 
Printed Name of Witness 
 
Date 
 
Time