Clinical trial NCT04227704
Conditions: Postpartum Depression
Sponsor: Washington University School of Medicine
Start date: 2020-11-12; Completion date: 2021-08-09
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators plan to randomise participants to receive ketamine or placebo control subcutaneously or by 40-minute intravenous infusions and will follow them up for 42 days to assess the incidence of postpartum depression. This feasibility pilot study is designed to explore the adequacy of the study procedures and tolerability of the interventions.

Detailed description:
Postpartum depression (PPD)

PPD is one of the most common perinatal medical complications and can have a detrimental effect on both mother and baby. Suicide exceeds hemorrhage and hypertensive disorders as a cause of maternal mortality and maternal psychopathology interferes with the parent-infant relationship. It has been estimated to have a period prevalence of 19.2% in the first 3 postpartum months. The rapid decline in reproductive hormones is thought to contribute to the development of PPD in susceptible women, although the specific pathogenesis is unknown. The American College of Obstetricians and Gynecologists recommend that all women should be routinely screened for depressive symptoms in the perinatal period.

Risk factors for PPD include:

* Depression during pregnancy • Breastfeeding problems
* Preterm birth/infant admission to neonatal intensive care (NICU)
* Traumatic birth experience
* History of depression
* Anxiety during pregnancy

Ketamine's anti-depressant effect

Ketamine, a phencyclidine derivative, is a non-competitive antagonist at the N-methyl-D-aspartic acid (NMDA) receptor that is commonly used as an anesthetic or sedative agent and has proven analgesic effect after a variety of surgeries including CD, where it has also been shown to reduce shivering. It has been demonstrated to have a rapid anti-depressant effect in treatment-resistant depression outside of pregnancy. The most commonly employed intravenous (IV) dose for this purpose is 0.5 mg/kg over 40 minutes, as single or repeated infusions. It has been postulated that prolonged blockade of NMDA receptors causes long-term changes in signal transduction leading to sustained clinical improvement, some investigators have explored longer term infusions such as those used to treat chronic pain. A recent pilot study assessing the feasibility of a 96-hour (\~0.5mg/kg/hr) infusion compared with a single 40-minute (0.5 mg/kg) infusion suggested a trend toward greater efficacy in the prolonged infusion but confirmation of a statistically significant result is awaited.

Ketamine and PPD

This promising anti-depressant effect has prompted investigation of ketamine as a preventative measure in patients undergoing CD. There have been 2 studies to date, one which failed to demonstrate any benefit from a bolus dose of 0.25 mg/kg and one which documented a large reduction (1 and 22% in the treatment and control, respectively) in the (6 week) period prevalence of postpartum depression after a 4 mg/kg dose of ketamine over 50 hours (\~0.08 mg/kg/hr).

The prolonged IV infusion, was achieved by adding the ketamine to a sufentanil patient-controlled analgesic (PCA) pump with a background infusion. This PCA pump is a standard part of their post-cesarean analgesic regimen. In our institution, it is standard practice to discontinue IV infusions and to remove IV cannulae as early as it is safe to do so. This practice is essential to the attempts to enhance postoperative recovery and aid mother's bonding with their babies and facilitate their early-life care. This reflects patients' expectations and preferences and is in line with other maternity units across North America and Europe.

The natural course of PPD varies and, although it may resolve spontaneously within weeks, approximately 20% of women with PPD still have depression at 12 months and beyond. As many as 13% will still have depressive symptoms at 2 years and 40% will have a relapse. Considering the maternal suffering, disruption to the family, potential impairment of the social, emotional, and cognitive development of the child, and the rare cases of infanticide and suicide caused by PPD, the impact on families and society as a whole is difficult to overemphasize. An intervention that promises such a large reduction in this devastating disease warrants extensive research. In an attempt to achieve the benefit whilst employing methods more acceptable to our patients we have designed a pilot study to assess the feasibility of our study design and collect preliminary tolerability and efficacy data on ketamine administered by two alternative routes: 40-minute IV infusion (i.v.) and subcutaneous (s.c.) injection.

Arms: arm 1: Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection and 40-minute intravenous infusion of 0.9% sodium chloride. arm 2: Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.5 mg/kg of ketamine and a 40-minute intravenous infusion of 0.9% sodium chloride. arm 3: Shortly after cesarean delivery of their baby, participants will receive a subcutaneous injection of 0.9% sodium chloride and a 40-minute intravenous infusion of 0.5 mg/kg ketamine.
Interventions: intervention 1: Ketamine 50 MG/ML intervention 2: Control
Intervention descriptions: intervention 1: Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion). intervention 2: Administration of 0.9% Sodium Chloride (N/S)

Protocol documents:
Prot_SAP_000.pdf: 
Version 01/24/2020 
 
1 
RESEARCH PROTOCOL 
 
Study Title 
Postpartum depression after Cesarean delivery:  
Ketamine as a preventative intervention.  
A feasibility pilot-study. 
 
Short Title 
The PoCKet pilot. 
 
Principal Investigator Dr David Thomas Monks MBChB FRCA MSc,  
Assistant Professor, Department of Anesthesiology,  
Washington University School of Medicine, 
660 S Euclid Avenue St. Louis. 
314-601-1572 
dmonks@wustl.edu 
 
Co-Investigators 
Dr Arvind Palanisamy, MBBS FRCA MD 
Associate Professor of Anesthesiology and Obstetrics and 
Gynecology, Division Chief of Obstetric Anesthesiology, 
Washington University School of Medicine. 
 
 
Dr Shannon Lenze, PhD 
Assistant Professor of Psychiatry, 
Director of Research, Perinatal Behavioral Health Service, 
Washington University School of Medicine. 
 
 
Dr Michael Avidan, MBBCh FCA(SA) 
Dr Seymour and Rose T. Brown Professor of Anesthesiology, 
Chair of the Department of Anesthesiology, Washington 
University School of Medicine. 
 
Dr Preet Mohinder Singh, MBBS 
Assistant Professor, Department of Anesthesiology, Washington 
University School of Medicine. 
 
 
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SYNOPSIS 
Study Title 
Postpartum depression after Cesarean delivery:  
Ketamine as a preventative intervention.  
A feasibility pilot-study (PoCKet Pilot). 
Primary Objective 
To assess the feasibility of the study by establishing:  
a) the incidence of PPD in our cohort; 
b) the acceptability to eligible patients; 
c) the ability of the investigative team to collect the data and; 
d) the tolerability of the interventions.  
Hypothesis 
We hypothesize that ketamine reduces the incidence of 
postpartum depression (PPD) when administered at 
cesarean delivery and that the subcutaneous route is well 
tolerated and has a favorable pharmacokinetic profile.  
Study Period 
Planned enrolment duration: 52 weeks 
Planned study duration: 58 weeks 
Number of Participants 
60 patients  
(20 in each of the subcutaneous [SC], intravenous [IVI] and 
control [P] groups) 
Study Intervention 
Patients in each group will receive both subcutaneous (s/c) 
and intravenous (i.v.) administration of their corresponding 
injectate shortly after delivery of their baby. The injectate will 
consist of either 0.9% Sodium Chloride (N/S) or 50 mg/ml 
ketamine (Ket) depending on their group allocation. The s/c 
injectate will be administered undiluted whereas the i.v. 
injectate will be diluted to make up a 40 ml infusion.  
Groups 
SC: 
IVI: 
P: 
s/c injectate 
Ket 
N/S 
N/S 
i.v. injectate 
N/S 
Ket 
N/S 
Study Design 
A randomised, double-blind, placebo-controlled feasibility 
pilot study 
Eligibility Criteria 
Inclusion criteria 
1. Term pregnancy 
2. Age 18-45 years of age 
3. Scheduled cesarean delivery under neuraxial 
anesthesia 
Exclusion criteria 
1. ASA classification IV or V 
2. History of psychotic episodes 
3. History of allergy to ketamine 
4. Inability to communicate in English or any other 
barrier to providing informed consent 
Measurements 
a) 
Psychosocial stress (Antenatal Risk Questionnaire 
[ANRQ]) 
b) 
Weight (kg) and height (m) 
c) 
Time of delivery of baby 
d) 
Total intraoperative dose of analgesic/sedative 
medication 
e) 
Baseline and intraoperative vital signs 
f) 
Maximum intraoperative pain (NRS) 
g) 
48-hour total opiate consumption (morphine 
equivalents) 
h) 
Apgar scores at 1 and 5 minutes postpartum 
i) 
Admission to NICU 


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j) 
Pain originating from surgical site (NRS 0-10): 2, 
6, 24 and 48 hours and 21 and 42 days 
postpartum. 
k) 
Edinburgh Postpartum Depression Scale (EPDS) 
and Generalized Anxiety Disorder 7-item (GAD-7) 
Scale: Day of surgery and postpartum days 1, 2, 
21 and 42 
l) 
Plasma concentrations of ketamine at baseline, 
20, 40 and 100 minutes after administration 
m) 
Breastfeeding success (Y/N): postpartum days 1 
and 2 
n) 
Adverse effects, intraoperatively and at 2 and 6 
hours postpartum (absent, mild, moderate or 
severe) 
Statistical Methodology 
Descriptive statistics will be employed to present the 
demographic data. Continuous variables will be summarized 
using means (SD) or medians (IQR), as appropriate. After 
construction of the concentration-time curves for each 
patient, the peak plasma concentration and area under the 
concentration-time curve will be summarized overall and 
associations with both antidepressant effect and incidence of 
adverse symptoms will be explored. 
NONMEM© 7.4 (ICON Development Solutions) software will 
be utilised to assess pharmacokinetic profile of ketamine by 
each route.   
 


Version 01/24/2020 
 
4 
TABLE OF CONTENTS 
SYNOPSIS 
Page  
2 
1 BACKGROUND AND SIGNIFICANCE 
1.1 
Postpartum depression (PPD) 
1.2 
Ketamine’s anti-depressant effect 
1.3 
Ketamine and PPD 
5 
 
2 OBJECTIVES 
7 
3 PATIENT SELECTION 
3.1 
Inclusion criteria 
3.2 
Exclusion Criteria 
3.3 
Inclusion of women and minorities 
7  
4 REGISTRATION PROCEDURES 
4.1 
Confirmation of patient eligibility 
4.2 
Patient registration 
4.3 
Assignment of unique participant identifier 
4.4 
Randomization 
7 
5 STUDY DESIGN 
7 
6 STUDY PROCEDURES 
6.1 
Intervention groups 
6.2 
Measurements 
8 
7 STUDY SCHEDULE 
9 
8 OBSERVATIONS AND MEASUREMENTS 
8.1 
Primary outcome measures 
8.2 
Secondary outcome measures 
10 
9 STATISTICAL METHODS 
9.1 
Sample size 
9.2 
Pharmacokinetic analysis 
10 
10 REGULATORY AND REPORTING REQUIREMENTS 
10.1 
Definitions 
10.2 
Reporting to the Human Research Protection Office 
(HRPO) at Washington University 
10.3 
Timeframe for reporting required events 
11 
11 REFERENCES 
12 
 
 
 


Version 01/24/2020 
 
5 
1. BACKGROUND AND SIGNIFICANCE 
 
1.1 
Postpartum depression (PPD)  
 
PPD is one of the most common perinatal medical complications and can have a detrimental 
effect on both mother and baby. Suicide exceeds hemorrhage and hypertensive disorders as 
a cause of maternal mortality1 and maternal psychopathology interferes with the parent-
infant relationship2. It has been estimated to have a period prevalence of 19.2% in the first 3 
postpartum months. The rapid decline in reproductive hormones is thought to contribute to 
the development of PPD in susceptible women, although the specific pathogenesis is 
unknown. The American College of Obstetricians and Gynecologists3 recommend that all 
women should be routinely screened for depressive symptoms in the perinatal period. The 
strongest risk factor is history of pre-existing mood disorder and Robertson et al.5 list 
additional risk factors (Table 1) for PPD in the postpartum period. 
 
 
Depression during pregnancy 
 
Breastfeeding problems 
 
Preterm birth/infant admission to 
neonatal intensive care (NICU) 
 
Traumatic birth experience 
 
History of depression 
 
Anxiety during pregnancy 
Table 1: Risk factors for PPD 
 
1.2 
Ketamine’s anti-depressant effect 
 
Ketamine, a phencyclidine derivative, is a non-competitive antagonist at the N-methyl-D-
aspartic acid (NMDA) receptor that is commonly used as an anesthetic or sedative agent 
and has proven analgesic effect after a variety of surgeries including CD6, where it has also 
been shown to reduce shivering7. It has been demonstrated to have a rapid anti-depressant 
effect in treatment-resistant depression8 outside of pregnancy. The most commonly 
employed intravenous (IV) dose for this purpose is 0.5 mg/kg over 40 minutes, as single or 
repeated infusions. It has been postulated that prolonged blockade of NMDA receptors 
causes long-term changes in signal transduction leading to sustained clinical improvement, 
some investigators have explored longer term infusions such as those used to treat chronic 
pain9. A recent pilot study assessing the feasibility of a 96-hour (~0.5mg/kg/hr) infusion10 
compared with a single 40-minute (0.5 mg/kg) infusion suggested a trend toward greater 
efficacy in the prolonged infusion but confirmation of a statistically significant result is 
awaited. 
 
1.3 
Ketamine and PPD 
 
This promising anti-depressant effect has prompted investigation of ketamine as a 
preventative measure in patients undergoing CD. There have been 2 studies to date11,12, 
one which failed to demonstrate any benefit from a bolus dose of 0.25 mg/kg and one which 
documented a large reduction (1 and 22% in the treatment and control, respectively) in the 
(6 week) period prevalence of postpartum depression after a 4 mg/kg dose of ketamine over 
50 hours (~0.08 mg/kg/hr). 
 
The prolonged IV infusion, in the Jianxin (2015)12 study, was achieved by adding the 
ketamine to a sufentanil patient-controlled analgesic (PCA) pump with a background 
infusion. This PCA pump is a standard part of their post-cesarean analgesic regimen. In our 
institution, it is standard practice to discontinue IV infusions and to remove IV cannulae as 
early as it is safe to do so. This practice is essential to the attempts to enhance 
postoperative recovery and aid mother’s bonding with their babies and facilitate their early-


Version 01/24/2020 
 
6 
life care. This reflects patients’ expectations and preferences and is in line with other 
maternity units across North America and Europe.  
 
The natural course of PPD varies and, although it may resolve spontaneously within weeks, 
approximately 20% of women with PPD still have depression at 12 months and beyond. As 
many as 13% will still have depressive symptoms at 2 years and 40% will have a relapse13. 
Considering the maternal suffering, disruption to the family, potential impairment of the 
social, emotional, and cognitive development of the child14, and the rare cases of infanticide 
and suicide caused by PPD, the impact on families and society as a whole is difficult to 
overemphasize. An intervention that promises such a large reduction in this devastating 
disease warrants extensive research. In an attempt to achieve the benefit demonstrated by 
Jianxin et al. whilst employing methods more acceptable to our patients we have designed a 
pilot study to assess the feasibility of our study design and collect preliminary tolerability and 
efficacy data on ketamine administered by two alternative routes: 40-minute IV infusion (i.v.) 
and subcutaneous (s.c.) injection. 
 
 


Version 01/24/2020 
 
7 
2 OBJECTIVES 
 
2.1 
To determine the feasibility of performing this study at our institution 
2.2 
To determine the pharmacokinetic profiles of ketamine when administered as a 
subcutaneous injection and an intravenous infusion at cesarean delivery 
2.3 
To obtain preliminary data to inform the design of a randomized controlled trial to 
assess the efficacy of ketamine as a preventive intervention at cesarean delivery 
against PPD 
 
3 PATIENT SELECTION 
 
3.1 
Inclusion criteria: 
3.1.1 Term pregnancy 
3.1.2 Age 18-45 years of age 
3.1.3 Scheduled cesarean delivery under neuraxial anesthesia 
3.2 
Exclusion criteria: 
3.2.1 ASA classification IV or V 
3.2.2 History of psychotic episodes 
3.2.3 History of allergy to ketamine 
3.2.4 Inability to communicate in English or any other barrier to providing 
informed consent 
3.3 
Inclusion of women and minorities: 
3.3.1 Eligible pregnant women of all ethnicities and cultures presenting to the 
Barnes Jewish Hospital Labor & Delivery floor will be invited to participate 
in this research 
 
4 REGISTRATION PROCEDURES 
 
4.1 
Confirmation of patient eligibility 
4.1.1 We will screen all patients scheduled for cesarean delivery and confirm 
their eligibility by assessing their: i) age; ii) gestational age; iii) medical 
history and; iv) allergy history. 
4.2 
Assignment of unique participant number 
4.2.1 Each patient will be identified with a unique participant number (UPN) for 
this study. All data will be recorded with this identification number on the 
appropriate case report form (CRF). 
4.3 
Randomization 
4.3.1 Patients will be randomly assigned to one of the three groups: SC, IVI or 
Control. The randomization will be performed in 1:1:1 ratio in blocks of 6, 
with no stratifications.  
 
5 STUDY DESIGN 
 
5.1 
This will be a double-blinded, placebo-controlled, feasibility pilot study. The primary 
outcomes are related to the ability of the study procedures to gather data on the 
interventions’ efficacy in preventing postpartum depression. Successful attainment of 
the following feasibility milestones (FM) is necessary to justify proceeding with a 
pragmatic clinical trial:  
5.1.1 FM1: Establish that the incidence of PPD in our cohort is >10% 
5.1.2 FM2: Achieve the recruitment of >50% of approached patients to 
demonstrate feasibility for an RCT 
5.1.3 FM3: Ensure that the design of assessments and data collection make it 
possible to achieve a complete dataset in >90% of participants 


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8 
5.1.4 FM4: Ascertain that none of chosen routes of administration of ketamine 
is intolerable to patients, as defined as the incidence of one or more 
severe side effects experienced by >10% of participants in that study arm.  
 
6 STUDY PROCEDURES 
 
6.1 
Participants will be assigned to one of three intervention groups (Table 2).  
 
Groups 
Subcutaneous injectate 
Intravenous injectate* 
SC (n=20) 
50 mg/ml ketamine 
0.9% Sodium Chloride 
IVI (n=20) 
0.9% Sodium Chloride 
50 mg/ml ketamine 
P (n=20) 
0.9% Sodium Chloride 
0.9% Sodium Chloride 
Table 2: Intervention groups. *the i.v. injectate will be diluted up to a 40 ml infusion.  
 
6.2 
Participants will have baseline data (Table 3) recorded on the relevant case report 
form on the day of delivery. This data will include demographics to assess the performance 
of randomization procedures as well as characteristics that have been demonstrated to 
confer an increased risk of PPD. The patient will be prepared for cesarean as per  
institutional protocols. 
 
Measure 
Units/values 
Age 
Years 
Height  
Metres 
Weight (day of surgery) 
Kilograms 
Gestational age  
Weeks 
Ethnicity  
White, Black/African American, Asian, Native 
American/Alaskan natives, Native Hawaiian, Pacific 
Islander, Hispanic/Latino 
Insurance status  
Insured/uninsured 
Psychiatric history 
PPD, major depressive disorder (MDD), anxiety, 
premenstrual syndrome (PMS), premenstrual dysphoric 
disorder (PMDD), mood disorder, personality disorder, 
psychotic disorder 
Current anxiety and 
depressive symptoms 
EPDS and GAD-7 
Psychosocial stress 
ANRQ 
Table 3: Baseline data 
 
Once an adequate sensory block is achieved, surgery will commence. Upon delivery of the 
baby, 0.01 ml/kg of the “subcutaneous injectate” will be injected subcutaneously and the 
“intravenous injectate” will be made up to a 40ml infusion (Table 4) and commenced at 60 
ml/hr. Both injectates will be administered/initiated approximately 0 - 5 minutes after delivery 
by the anesthetic provider via one of the cannulae that they will be using for standard patient 
care. The intravenous study infusion will be prepared by a member of the investigative team, 
who will not be involved in data collection. 
 
Add 0.01 ml/kg of the “IVI study solution” to a 60ml syringe and use 0.9% sodium chloride 
to dilute the solution to 40ml.   
Table 4: Instructions for preparing the “IVI study infusion” 
 
Measurements:  
1. Baseline data 
2. EPDS and GAD-7 scores at baseline and approximately 1, 2, 21 and 42 days 
postpartum 


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9 
3. ANRQ at baseline 
4. Time of delivery of baby 
5. Total intraoperative dose of any analgesic/sedative medication 
6. Incidence of hypo- or hypertension (systolic BP < 80 or > 170 mmHg, respectively) 
and brady- or tachycardia (pulse < 40 or > 120 bpm, respectively) 
7. Maximum intraoperative pain (numerical rating scale [NRS], 0-10) 
8. Incidence of the signs/symptoms in Table 5 will be assessed intraoperatively and 
approximately 2 and 6 hours after delivery. The presence of each adverse effect will 
be assessed using a 4-point scale (absent, mild, moderate, severe). 
 
Nausea 
Shivering 
Blurred vision 
Vomiting 
Anxiety 
Diplopia 
Pruritus 
Euphoria 
Nystagmus 
Dizziness 
Hallucinations 
 
Sedation 
Amnesia 
 
Table 5: Adverse effects 
 
9. Surgical site pain (NRS) at 2, 6, 24 and 48 hours, as well as 21 and 42 days, 
postpartum. 
10. Opiate consumption in the first 48 hours (measured in morphine equivalents) will be 
calculated. 
11. Plasma concentrations of ketamine at baseline and approximately 20, 40 and 100 
minutes postpartum.  
 
7 STUDY SCHEDULE 
 
 
Study Event 
Baseline 
Perioperative 
(approximate 
minutes after 
delivery) 
Postoperative 
(approximate hours 
after delivery) 
Outpatient 
(approxim
ate days 
after 
delivery) 
20 
40 
100 
2 
6 
24 
48 
21 
42 
Informed 
consent 
 
 
 
 
 
 
 
 
 
 
Eligibility/ 
Demographics 
 
 
 
 
 
 
 
 
 
 
Randomization 
 
 
 
 
 
 
 
 
 
 
Blood Sample 
Collection 
 
 
 
 
 
 
 
 
 
 
Maximum 
intraoperative 
pain (NRS, 0-
10) score 
 
 
 
 
 
 
 
 
 
 
Adverse Effects 
 
 
 
 
 
 
 
 
 
 
Breastfeeding 
Success 
 
 
 
 
 
 
 
 
 
 
Surgical Site 
Pain (NRS) 
 
 
 
 
 
 
 
 
 
 
EPDS 
 
 
 
 
 
 
 
 
 
 
GAD 7 
 
 
 
 
 
 
 
 
 
 
ANRQ 
 
 
 
 
 
 
 
 
 
 
Table 6: Study schedule 
 
 


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10 
 
8 OBSERVATIONS AND MEASUREMENTS 
 
8.1 
Primary outcome measures 
8.1.1 FM1: Establish that the incidence of PPD in our cohort is >10% 
8.1.2 FM2: Achieve the recruitment of >50% of approached patients to 
demonstrate feasibility for an RCT 
8.1.3 FM3: Ensure that the design of assessments and data collection make it 
possible to achieve a complete dataset in >90% of participants 
8.1.4 FM4: Ascertain that neither of the chosen routes of administration of 
ketamine are intolerable to patients, as defined as the incidence of one or 
more severe side effects experienced by >10% of participants in that 
study arm.  
 
8.2 
Secondary outcome measures 
8.2.1 Intraoperative supplementary analgesia 
8.2.2 Intraoperative hypo/hypertension and brady-/tachycardia 
8.2.3 Maximum intraoperative pain (NRS) 
8.2.4 Adverse effects intraoperatively and at approximately 2 and 6 hours 
postpartum 
8.2.5 Plasma concentrations of ketamine at baseline and approximately 20, 40 
and 100 minutes postpartum. Samples will be centrifuged and the 
extracted plasma samples will be stored at -80 degrees Celsius before 
transfer to the metabolomics laboratory at Washington University for 
ketamine assay. 
8.2.6 Total opiate consumption in the first 2 days postpartum 
8.2.7 Surgical site pain (NRS 0-10), by face-to-face or telephone interview, at 2, 
6, 24 and 48 hours after delivery and on postpartum days 21 and 42. 
8.2.8 EPDS and GAD-7 on postpartum days 1 and 2, by face to face interview, 
and days 21 and 42, by telephone interview. 
8.2.9 Apgar scores 
8.2.10 Admission to NICU  
8.2.11 Breastfeeding success (Y/N) on post-operative days 1 and 2 
 
9 STATISTICAL METHODS 
 
9.1 
Sample size and analysis  
No formal sample size has been performed as this is a pilot designed to establish the 
feasibility of an RCT. Preliminary data from this study will be used to inform the 
sample size calculation for the subsequent clinical trial. Descriptive statistics will be 
employed to present the demographic data. Continuous variables will be summarized 
using means (SD) or medians (IQR), as appropriate. After construction of the 
concentration-time curves for each patient, the peak plasma concentration and area 
under the concentration-time curve will be summarized overall and associations with 
both antidepressant effect and incidence of adverse symptoms will be explored. 
 
9.2 
Pharmacokinetic analysis  
NONMEM® 7.4 (ICON Development Solutions) software will be utilised to assess 
pharmacokinetic profile of ketamine by each route.   
 
 
 
 


Version 01/24/2020 
 
11 
 
10 REGULATORY AND REPORTING REQUIREMENTS 
 
10.1 
Definitions 
 
Adverse event (AE): Any unfavorable medical occurrence in a human subject 
including any abnormal sign, symptom, or disease. 
 
Serious adverse event (SAE): Any adverse drug experience occurring at any dose 
that results in any of the following outcomes: 
 
Death 
 
A life-threatening adverse drug experience 
 
Inpatient hospitalization or prolongation of existing hospitalization 
 
A persistent or significant disability/incapacity (i.e. a substantial disruption of a 
person’s ability to conduct normal life functions). 
 
A congenital anomaly/birth defect 
 
Any other experience which, based upon appropriate medical judgment, may 
jeopardize the subject and may require medical or surgical intervention to 
prevent on of the outcomes listed above 
 
 
Unanticipated problem: Unexpected (in terms of nature, severity, or frequency) given 
(a) the research procedures that are described in the protocol-related documents, 
such as the IRB-approved research protocol and informed consent document, and 
(b) the characteristics of the subject population being studied; related or possibly 
related to participation in the research (“possibly related” means there is a 
reasonable possibility that the incident, experience, or outcome may have been 
caused by the procedures involved in the research); and suggests that the research 
places subjects or others at a greater risk of harm (including physical, psychological, 
economic, or social harm) than was previously known or recognized. 
 
Noncompliance: Failure to follow any applicable regulations or institutional policies 
that govern human subject’s research or failure to follow the determinations of the 
IRB.  Noncompliance may occur due to lack of knowledge or due to deliberate choice 
to ignore regulations, institutional policies, or determinations of the IRB. 
 
10.2 
Reporting to the Human Research Protection Office (HRPO) at Washington 
University 
 
The PI is required to promptly notify the IRB of the following events: 
 
 
Any unanticipated problems involving risks to participants or others which occur 
at WU, any BJH or SLCH institution, or that impacts participants or the conduct of 
the study. 
 
Noncompliance with federal regulations or the requirements or determinations of 
the IRB. 
 
Receipt of new information that may impact the willingness of participants to 
participate or continue participation in the research study. 
 
10.3 
Timeframe for reporting required events 
 
These events must be reported to the IRB within 10 working days of the occurrence 
of the event or notification to the PI of the event.  The death of a research participant 
that qualifies as a reportable event should be reported within 1 working day of the 
occurrence of the event or notification to the PI of the event. 


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12 
 
Adverse events: The investigator will closely monitor subjects for evidence of 
adverse events.  We review data on a regular basis.  All adverse events will be 
reported and followed until satisfactory resolution. The description of the adverse 
experience will include the time of onset, duration, intensity, etiology, relationship to 
the study drug (none, unlikely, possible, probable, highly probable), and any 
treatment required. 
 
11 REFERENCES 
 
1 
Palladino CL, Singh V, Campbell J, Flynn H, Gold KJ. Homicide and suicide 
during the perinatal period: findings from the National Violent Death Reporting 
System. Obstet Gynecol 2011; 118: 1056–63.  
2 
Parsons CE, Young KS, Rochat TJ, Kringelbach ML, Stein A. Postnatal 
depression and its effects on child development: a review of evidence from low- 
and middle-income countries. Br Med Bull. 2012; 101: 57-79.  
3 
Gavin NI, Gaynes BN, Lohr KN, Meltzer-Brody S, Gartlehner G, Swinson T. 
Perinatal depression: a systematic review of prevalence and incidence. Obstet 
Gynecol. 2005 Nov; 106(5 Pt 1): 1071-83. Review.  
4 
Committee on Obstetric Practice. The American College of Obstetricians and 
Gynecologists Committee Opinion no. 630. Screening for perinatal depression. 
Obstet Gynecol. 2015 May; 125(5): 1268-71. 
5 
Robertson E, Grace S, Wallington T, Stewart DE. Antenatal risk factors for 
postpartum depression: a synthesis of recent literature. Gen Hosp Psychiatry 
2004; 26: 289-95.  
6 
Heesen M, Böhmer J, Brinck EC, Kontinen VK, Klöhr S, Rossaint R, Straube S. 
Intravenous ketamine during spinal and general anaesthesia for caesarean 
section: systematic review and meta-analysis. Acta Anaesthesiol Scand. 2015 
Apr; 59(4): 414-26.  
7 
Liu J, Wang Y, Ma W. Shivering prevention and treatment during cesarean 
delivery under neuraxial anesthesia: a systematic review. Minerva Anestesiol. 
2018 Jun 26. 
8 
Sanacora G, Frye MA, McDonald W, Mathew SJ, Turner MS, Schatzberg AF, 
Summergrad P, Nemeroff CB. American Psychiatric Association (APA) Council of 
Research Task Force on Novel Biomarkers and Treatments. A consensus 
statement on the use of ketamine in the treatment of mood disorders. JAMA 
Psychiatry. 2017; 74(4): 399-405.  
9 
Niesters M, Martini C, Dahan A. Ketamine for chronic pain: risks and benefits. Br 
J Clin Pharmacol. 2014; 77: 357–367. 
10 Lenze EJ, Farber NB, Kharasch E, Schweiger J, Yingling M, Olney J, Newcomer 
JW. Ninety-six-hour ketamine infusion with co-administered clonidine for 
treatment-resistant depression: A pilot randomised controlled trial. World J Biol 
Psychiatry. 2016 Apr; 17(3): 230-8  
11 Xu Y, Li Y, Huang X, Chen D, She B, Ma D. Single bolus low-dose of ketamine 
does not prevent postpartum depression: a randomized, double-blind, placebo-
controlled, prospective clinical trial. Arch Gynecol Obstet. 2017 May; 295(5): 
1167-1174.  
12 Jianxin G, Junmei X. Efficacy of ketamine in preventing postpartum depression. 
Chin J Anesthesiol 2015; 35(6): 674 - 676 16. 
13 Goodman JH. Postpartum depression beyond the early postpartum period. J 
Obstet Gynecol Neonatal Nurs 2004; 33: 410-20.  
14 Stein A, Pearson RM, Goodman SH, Rapa E, Rahman A, McCallum M, Howard 
LM, Pariante CM. Effects of perinatal mental disorders on the fetus and child. 
Lancet 2014; 384: 1800-19 

ICF_001.pdf: 
 
FOR IRB USE ONLY 
IRB ID #: 201910191 
APPROVAL DATE: 01/28/20 
RELEASED DATE: 01/29/20 
EXPIRATION DATE: 11/25/20 
 
INFORMED CONSENT DOCUMENT 
 
Project Title: 
Postpartum depression after Cesarean delivery: Ketamine as a preventative 
intervention. A feasibility pilot-study 
 
Principal Investigator: 
Dr. David Thomas Monks, MBChB FRCA MSc 
 
Research Team Contact: 
Dr. David Thomas Monks, 314-273-2633 
 
Benjamin Swan RN, 314-273-8257 
 
This consent form describes the research study and helps you decide if you want to participate.  It 
provides important information about what you will be asked to do during the study, about the risks and 
benefits of the study, and about your rights and responsibilities as a research participant. By signing this 
form you are agreeing to participate in this study. 
 You should read and understand the information in this document including the procedures, 
risks and potential benefits.  
 If you have questions about anything in this form, you should ask the research team for more 
information before you agree to participate.   
 You may also wish to talk to your family or friends about your participation in this study. 
 Do not agree to participate in this study unless the research team has answered your 
questions and you decide that you want to be part of this study.  
 
WHAT IS THE PURPOSE OF THIS STUDY? 
 
This is a research study.  We invite you to participate in this research study because you are a healthy 
woman having a planned cesarean delivery of your baby.  
 
The purpose of this research study is to determine whether or not the drug ketamine (0.5 mg/kg), 
administered intravenously or injected under the skin, compared to a placebo, is an effective prevention 
against postpartum depression (PPD).   
 
PPD is one of the most common medical complications surrounding pregnancy, with an estimated 
prevalence of 19.2% in the first 3 months following childbirth, and can have devastating effects on both 
mother and baby, including: maternal suffering, disruption of the parent-infant relationship, and in rare 
cases, suicide and/or infanticide (killing one’s own child).  PPD can also potentially impair the social, 
emotional, and cognitive development of a child.  Unfortunately, the exact cause of PPD remains 
unknown.  
 
Ketamine has shown some promise as a potential treatment to prevent PPD. Ketamine has been shown 
to be an effective pain killer during cesarean delivery and it is commonly used for this purpose; 
however, previous studies in non-pregnant populations have shown that ketamine also has an anti-
depressant effect in treatment-resistant depression, and one study demonstrated a large reduction in the 
occurrence of PPD in women undergoing cesarean delivery. In that study the ketamine was given by an 
infusion over 2 days, but in this study the ketamine administration will be completed in the operating 
room within 40 minutes. 


 
FOR IRB USE ONLY 
IRB ID #: 201910191 
APPROVAL DATE: 01/28/20 
RELEASED DATE: 01/29/20 
EXPIRATION DATE: 11/25/20 
 
 
Page 2 of 10 
 
 
 Ketamine is approved by the U.S. Food and Drug Administration (FDA) as an anesthetic (a drug that 
induces insensitivity to pain). However, the use of ketamine is considered investigational in this study.  
 
 
WHAT WILL HAPPEN DURING THIS STUDY? 
 
Should you decide to participate in this study, we will interview you and/or review your medical records 
to collect basic information about you (e.g. age, weight, height, ethnicity, etc.), your insurance status 
(i.e. insured/uninsured), your current and previous pregnancies and deliveries, and any current and/or 
previous physical and mental health problems, surgeries, and medications. 
 
Prior to your surgery, you will be randomized (assigned by chance, like rolling dice) to one of the three 
treatments- this treatment will be given immediately following the delivery of your baby.  An 
intravenous catheter (IV) will be placed in a vein in one of your arms in addition to the standard IV 
catheter required for the cesarean delivery.  This IV will be used to collect blood from you during your 
procedure.  Additionally, you will be asked to complete depression, anxiety, and psychosocial stress 
surveys (EPDS, GAD-7, and ANRQ, respectively) prior to being brought into the operating room (OR). 
You are free to skip any question you prefer not to answer on any survey. 
 
Immediately following the delivery of your baby, you will receive the treatment you were randomized 
to.  Regardless of treatment, you will receive 0.01 mL/kg of a drug or placebo injected under the skin 
and 0.01 mL/kg of an intravenous drug or placebo, infused over 40 minutes.  You may receive placebo 
(salt water solution) in both the injection under the skin and the intravenous infusion or one of these 
routes may be 50 mg/mL of ketamine and the other route will be placebo (salt water solution).   
 
During your surgery, we will collect blood from you at four time points before and after the delivery of 
your baby: Baseline and 20, 40, and 100 minutes after delivery.  Following collection of the blood 
sample at the 100 minute time point, you will also be asked about your pain and any adverse effects you 
may or may not be experiencing.  Additional information from your surgery (e.g. time of delivery, vital 
signs, medications given, APGAR scores, etc.) may be obtained from your medical records after the 
surgery is completed. 
 
After your surgery, we will follow up with you at several time points while you are still in the hospital: 
2, 6, 24, and 48 hours after surgery.  At the 2 and 6 hour time points following surgery, you will be 
interviewed about your pain and any adverse effects (side effects) you may or may not be experiencing. 
At approximately 24 and 48 hours after surgery, you will again be asked about your pain level; however, 
at these times we will also follow up with you regarding your ability to breast feed (if applicable) and 
will ask you to complete the EPDS and GAD-7 surveys that you completed prior to your operation. 
 
Two follow up telephone calls will be made at 21 and 42 days after you deliver your baby.  During these 
telephone calls, you will again be asked about your pain level and will be asked the questions on the 
EPDS and GAD-7 surveys. 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 201910191 
APPROVAL DATE: 01/28/20 
RELEASED DATE: 01/29/20 
EXPIRATION DATE: 11/25/20 
 
 
Page 3 of 10 
Will you save my research information and/or biospecimens to use in future research studies? 
 
We would like to use the blood and data we are obtaining in this study for studies going on right now as 
well as studies that are conducted in the future.  These studies may provide additional information that 
will be helpful in understanding the prevention of PPD, or other diseases or conditions, including 
research to develop investigational tests, treatments, drugs or devices that are not yet approved by the 
U.S. Food and Drug Administration.  It is unlikely that what we learn from these studies will have a 
direct benefit to you.  There are no plans to provide financial compensation to you should this occur.  By 
allowing us to use your blood and data you give up any property rights you may have in the blood and 
data. 
 
 
We may share your blood and data with other researchers.  They may be doing research in areas similar 
to this research or in other unrelated areas.  These researchers may be at Washington University, at other 
research centers and institutions, or industry sponsors of research.  We may also share your research data 
with large data repositories (a repository is a database of information) for broad sharing with the 
research community.  If your individual research data is placed in one of these repositories only 
qualified researchers, who have received prior approval from individuals that monitor the use of the 
data, will be able to look at your information.  
 
If you change your mind and do not want us to store and use your blood and data for future research you 
should contact the research team member identified at the top of this document.  The blood and data will 
no longer be used for research purposes.  However, if some research with your blood and data has 
already been completed, the information from that research may still be used.  Also, if the blood and 
data has been shared with other researchers it might not be possible to withdraw the blood and data to 
the extent it has been shared. 
 
Please place your initials in the blank next to Yes or No for each of the questions below: 
 
My blood and data may be stored and used for future research as described above. 
 
_____ Yes 
_____ No 
Initials  
Initials 
 
My blood and data may be shared with other researchers and used by these researchers for the 
future research as described above. 
 
_____ Yes  
_____ No 
Initials  
Initials 
 
 
Identifiers may be removed from your private information, including blood and data, and used for future 
research or shared with others.  If this occurs, we will not ask you for additional consent. 
 


 
FOR IRB USE ONLY 
IRB ID #: 201910191 
APPROVAL DATE: 01/28/20 
RELEASED DATE: 01/29/20 
EXPIRATION DATE: 11/25/20 
 
 
Page 4 of 10 
 
HOW MANY PEOPLE WILL PARTICIPATE? 
 
Approximately 60 people will take part in this study conducted by investigators at Washington 
University. 
 
HOW LONG WILL I BE IN THIS STUDY? 
 
If you agree to take part in this study, your involvement will last for approximately 6 weeks.  You will 
initially be followed from the time of consent until discharge from the hospital or 48 hours following 
delivery, whichever comes first.  You will be contacted via telephone at approximately 21 days and 42 
days following delivery for additional follow up (e.g. pain assessment and depression survey). 
 
WHAT ARE THE RISKS OF THIS STUDY? 
 
You may experience one or more of the risks indicated below from being in this study. In addition to 
these, there may be other unknown risks, or risks that we did not anticipate, associated with being in this 
study.   
 
Some risks described in this consent document, if severe, may cause death.  
 
Intravenous and Subcutaneous Ketamine: 
Likely/Common: Dream-like feeling, euphoria (intense feeling of happiness), blurred vision, 
drowsiness, nausea, vomiting, loss of appetite, sleep problems 
Less Likely/Less Common: Amnesia (loss of memory), rapid eye movement, double vision, dizziness, 
jerky muscle movements 
Rare:  Confusion, anxiety, hallucinations, unusual thoughts, fear 
 
Intravenous Catheter 
Likely/Common: Pain at insertion site, bruising and/or bleeding at insertion site 
Less Likely/Less Common: Infection at insertion site 
Rare: None 
 
Questionnaires and Assessments 
Completing the questionnaires or assessments may cause emotional discomfort; however, you have the 
right to refuse to answer any question for any reason. 
 
Breach of Confidentiality 
One risk of participating in this study is that confidential information about you may be accidentally 
disclosed.  We will use our best efforts to keep the information about you secure.  Please see the section 
in this consent form titled “How will you keep my information confidential?” for more information. 
 
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 201910191 
APPROVAL DATE: 01/28/20 
RELEASED DATE: 01/29/20 
EXPIRATION DATE: 11/25/20 
 
 
Page 5 of 10 
WHAT ARE THE BENEFITS OF THIS STUDY? 
 
You may or may not benefit from being in this study.   
 
However, we hope that in the future, other people might benefit from this study because the information 
provided may help us to reduce the prevalence of postpartum depression by using ketamine as a 
preventative intervention at cesarean delivery. 
 
WHAT OTHER TREATMENT OPTIONS ARE THERE? 
 
Before you decide whether or not to be in this study, your doctor will discuss the other options that are 
available to you.  Instead of being in this study, you could choose to have your planned cesarean 
delivery without being in this study. 
 
WILL IT COST ME ANYTHING TO BE IN THIS STUDY? 
 
As part of this study you will receive tests and procedures that are similar to what you would receive 
during routine clinical care of your condition.  Your health plan/insurance company will be billed for 
some or all of these costs, and you will be responsible for any co-pays and deductibles that are normally 
required by your health plan/insurance.  Not all insurance plans cover the costs associated with being in 
a study. Even if they do, you may be responsible for more out-of-pocket expenses, such as co-pays and 
deductibles, when there are more tests and procedures or more expensive tests and procedures involved 
in the study than if you were to receive routine clinical care outside the study.   
 
If you wish to know whether there are more tests and procedures or more expensive tests and procedures 
in the study, you should ask your study doctor.   
 
If you wish to know whether your insurance will pay, you should contact them directly, or speak with 
the study team about obtaining a financial pre-certification prior to enrolling in the study. 
 
The study is providing the ketamine at no cost to you.  
 
WILL I BE PAID FOR PARTICIPATING? 
 
You will be paid for being in this research study. You will need to provide your social security number 
(SSN) in order for us to pay you. You may choose to participate without being paid if you do not wish to 
provide your social security number (SSN) for this purpose.  You may also need to provide your address 
if a check will be mailed to you. Checks are mailed within approximately 2 weeks of each study 
milestone outlined below.  If your social security number is obtained for payment purposes only, it will 
not be retained for research purposes.    
 
In total, you will receive $50 for participating in this research study. You will receive one $25 check 
upon completion of the last in-hospital follow-up at approximately 48 hours following your surgery, and 
a second $25 check following completion of the final follow-up procedures at approximately 42 days 
following your surgery. If you do not complete all study follow ups you will be paid for those you do 
complete.  


 
FOR IRB USE ONLY 
IRB ID #: 201910191 
APPROVAL DATE: 01/28/20 
RELEASED DATE: 01/29/20 
EXPIRATION DATE: 11/25/20 
 
 
Page 6 of 10 
WHO IS FUNDING THIS STUDY? 
 
The University and the research team are not receiving payment from other agencies, organizations, or 
companies to conduct this research study.  
 
WHAT IF I AM INJURED AS A RESULT OF THIS STUDY? 
 
Washington University investigators and staff will try to reduce, control, and treat any complications 
from this research. If you feel you are injured because of the study, please contact the investigator, Dr. 
David Monks, at 314-273-2633 and/or the Human Research Protection Office at 1-(800)-438-0445.  
 
Decisions about whether payment for medical treatment for injuries relating to your participation in 
research will be made by Washington University. If you need to seek medical care for a research-related 
injury, please notify the investigator as soon as possible.  
 
HOW WILL YOU KEEP MY INFORMATION CONFIDENTIAL? 
 
Other people such as those indicated below may become aware of your participation in this study and 
may inspect and copy records pertaining to this research.  Some of these records could contain 
information that personally identifies you. We will keep your participation in this research study 
confidential to the extent permitted by law.   
 Government representatives (including the Office for Human Research Protections) to complete 
federal or state responsibilities 
 The U.S. Food and Drug Administration 
 Hospital or University representatives to complete Hospital or University responsibilities 
 Information about your participation in this study may be documented in your health care records 
and will be available to anyone with access to your health care record, including your health 
insurance company.  This information may also be released as part of a release of information 
request. 
 The last four digits of your social security number may be used in hospital or University systems 
to track billing information for research procedures. 
 Washington University’s Institutional Review Board (a committee that oversees the conduct of 
research involving human participants) and the Human Research Protection Office. The 
Institutional Review Board has reviewed and approved this study.  
 Any report or article that we write will not include information that can directly identify you.  
The journals that publish these reports or articles require that we share your information that was 
collected for this study with others to make sure the results of this study are correct and help 
develop new ideas for research. Your information will be shared in a way that cannot directly 
identify you. 
 
To help protect your confidentiality, we will keep all study documents in a locked facility to which only 
study personnel will have access.  The samples will be stored with your patient ID, in a secure 
laboratory to which only the study team will have access.   
 
 


 
FOR IRB USE ONLY 
IRB ID #: 201910191 
APPROVAL DATE: 01/28/20 
RELEASED DATE: 01/29/20 
EXPIRATION DATE: 11/25/20 
 
 
Page 7 of 10 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. 
Law. This Web site will not include information that can identify you. At most, the Web site will 
include a summary of the results. You can search this Web site at any time.  
 
Are there additional protections for my health information? 
 
Protected Health Information (PHI) is health information that identifies you. PHI is protected by federal 
law under HIPAA (the Health Insurance Portability and Accountability Act). To take part in this 
research, you must give the research team permission to use and disclose (share) your PHI for the study 
as explained in this consent form.  The research team will follow state and federal laws and may share 
your health information with the agencies and people listed under the previous section titled, “How will 
you keep my information confidential?” 
 
Once your health information is shared with someone outside of the research team, it may no longer be 
protected by HIPAA.   
 
The research team will only use and share your information as talked about in this form or as permitted or 
required by law.  When possible, the research team will make sure information cannot be linked to you 
(de-identified).  Once information is de-identified, it may be used and shared for other purposes not 
discussed in this consent form. If you have questions or concerns about your privacy and the use of your 
PHI, please contact the University’s Privacy Officer at 866-747-4975.  
 
Although you will not be allowed to see the study information, you may be given access to your health 
care records by contacting your health care provider.  
 
If you decide not to sign this form, it will not affect 
 your treatment or the care given by your health provider. 
 your insurance payment or enrollment in any health plans.   
 any benefits to which you are entitled. 
However, it will not be possible for you to take part in the study. 
 
If you sign this form: 
 You authorize the use of your PHI for this research 
 This authorization does not expire. 
 You may later change your mind and not let the research team use or share your information 
(you may revoke your authorization).  
 To revoke your authorization, complete the withdrawal letter, found in the Participant section 
of the Human Research Protection Office website at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ or you may request that the 
investigator send you a copy of the letter.    
 
 
 
o If you revoke your authorization: 
 The research team may only use and share information already collected for 
the study. 


 
FOR IRB USE ONLY 
IRB ID #: 201910191 
APPROVAL DATE: 01/28/20 
RELEASED DATE: 01/29/20 
EXPIRATION DATE: 11/25/20 
 
 
Page 8 of 10 
 Your information may still be used and shared as necessary to maintain the 
integrity of the research, for example, to account for a participant’s 
withdrawal from the research study or for safety reasons. 
 You will not be allowed to continue to participate in the study. 
 
Can we contact you by email? 
 
We would like to contact you by email for the purposes listed below.  Some of these emails may contain 
health information that identifies you. 
 Follow up communication regarding pain assessment, survey collection, and/or adverse 
effect monitoring. 
 
Only the research team will have access to your email communications.  We will only communicate by 
email to send you the information listed above.  If you have any questions or need to contact us for an 
urgent or emergent situation, please contact the research team member identified at the top of this 
document. 
 
You should be aware that there are risks associated with sending your health information via email.   
 There is always a risk that the message could be intercepted or sent to the wrong email 
address.  To avoid sending messages to the wrong email address, the first email we send you 
will be a test message to ensure we have the correct email address. 
 When using any computer you should be careful to protect your username and password.  
Make sure you log-out before getting up from the computer.   
 If you share a home computer with other family members, and do not want them to know you 
are participating in this study make sure you provide an email address that only you can 
access.  
 Your employer will have access to any email communications sent or received on any 
electronic devices used for work or through a work server. 
  
Do you agree to allow us to send your health information via email?   
 
_____ Yes  
_____ No 
Initials  
Initials 
 
IS BEING IN THIS STUDY VOLUNTARY? 
 
Taking part in this research study is completely voluntary.  You may choose not to take part at all.  If 
you decide to be in this study, you may stop participating at any time. Any data that was collected as 
part of your participation in the study will remain as part of the study records and cannot be removed.   
 
If you decide not to be in this study, or if you stop participating at any time, you won’t be penalized or 
lose any benefits for which you otherwise qualify.   
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 201910191 
APPROVAL DATE: 01/28/20 
RELEASED DATE: 01/29/20 
EXPIRATION DATE: 11/25/20 
 
 
Page 9 of 10 
What if I decide to withdraw from the study? 
 
You may withdraw by telling the study team you are no longer interested in participating in the study or 
you may send in a withdrawal letter. A sample withdrawal letter can be found at 
https://hrpo.wustl.edu/participants/withdrawing-from-a-study/ under Withdrawing from a Research 
Study. 
 
If you withdraw from the study we will ask your permission to continue to follow up via telephone calls 
and/or electronic medical record review.  Should this occur we will ask you to sign a separate consent 
form before collecting this information.  
 
Will I receive new information about the study while participating? 
 
If we obtain any new information during this study that might affect your willingness to continue 
participating in the study, we’ll promptly provide you with that information. 
 
Can someone else end my participation in this study? 
 
Under certain circumstances, the investigator might decide to end your participation in this research 
study earlier than planned.  This might happen for no reason or because in our judgement it would not be 
safe for you to continue, because your condition has changed, or because of delays in case start time due 
to the Labor & Delivery workload.  
 
WHAT IF I HAVE QUESTIONS? 
 
We encourage you to ask questions.  If you have any questions about the research study itself, please 
contact: Benjamin Swan RN, 314-273-8257.  If you experience a research-related injury, please contact: 
Dr. David Monks, 314-273-2633.  
 
If you have questions, concerns, or complaints about your rights as a research participant, please contact 
the Human Research Protection Office 1-(800)-438-0445, or email hrpo@wustl.edu.   General 
information about being a research participant can be found on the Human Research Protection Office 
web site, http://hrpo.wustl.edu.  To offer input about your experiences as a research participant or to 
speak to someone other than the research staff, call the Human Research Protection Office at the number 
above. 
 
 
 
 
 
 
 
 
 
 
 


 
FOR IRB USE ONLY 
IRB ID #: 201910191 
APPROVAL DATE: 01/28/20 
RELEASED DATE: 01/29/20 
EXPIRATION DATE: 11/25/20 
 
 
Page 10 of 10 
This consent form is not a contract. It is a written explanation of what will happen during the study if 
you decide to participate. You are not waiving any legal rights by agreeing to participate in this study. 
As a participant you have rights and responsibilities as described in this document and including: 
 To be given enough time before signing below to weigh the risks and potential benefits and 
decide if you want to participate without any pressure from the research team or others. 
 To understand all of the information included in the document, have your questions answered, 
and receive an explanation of anything you do not understand. 
 To follow the procedures described in this document and the instructions of the research team to 
the best of your ability unless you choose to stop your participation in the research study. 
 To give the research team accurate and complete information. 
 To tell the research team promptly about any problems you have related to your participation, or 
if you are unable to continue and wish to stop participating in the research study. 
 
Your signature indicates that this research study has been explained to you, that your questions have 
been answered, and that you agree to take part in this study.  You will receive a signed and dated copy 
of this form. 
 
 
Do not sign this form if today’s date is after EXPIRATION DATE: 11/25/20. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Participant) 
 
 
 
 
(Date) 
 
 
____________________________________________ 
(Participant's name – printed) 
 
 
 
Statement of Person Who Obtained Consent 
 
The information in this document has been discussed with the participant or, where appropriate, with the 
participant’s legally authorized representative.  The participant has indicated that they understand the 
risks, benefits, and procedures involved with participation in this research study. 
 
 
__________________________________________ 
_______________________________ 
(Signature of Person who Obtained Consent) 
 
(Date) 
 
 
___________________________________________ 
(Name of Person who Obtained Consent - printed)