A Pilot Study: To Compare Physical Activity After a Normal Spontaneous or Cesarean Delivery by Use of a Actigraph GT3X
Phase: NA
Conditions: Postpartum Disorder
Sponsor: Rutgers, The State University of New Jersey

Title: A Pilot Study: To compare physical activity after a normal spontaneous or cesarean delivery by use of a Actigraph GT3X 
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Tittle: A Pilot Study: To compare  physical activity after a normal spontaneous or cesarean 
delivery by use of a Actigraph  GT3X 
NCT#: 02967016 
May 12, 2020 

Title: A Pilot Study: To compare physical activity after a normal spontaneous or cesarean delivery by use of a Actigraph GT3X 
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1. Purpose/Specific Aims
This study aims to determine the average level of physical activity using average step counts
and daily MET min-1 following vaginal and cesarean delivery through use of Actigraph
GT3X (a fitness tracker).
1.1 Objectives
The main objective of the study is to determine the average level of physical activity using
mean daily steps and daily MET min-1, in women post vaginal and cesarean delivery.
1.2 Hypotheses 
The Actigraph GT3X will determine physical activity and step counts and these will be greater 
in women following vaginal delivery compared to cesarean delivery in a 48 hour period.  
2. Background and Significance
Cesarean delivery is the most common surgery performed in the United States.1 Despite this fact, 
there is a paucity of literature looking into the implementation of enhanced recovery after 
surgery (ERAS) for patients undergoing this type of surgery. ERAS protocols have shown to 
improve recovery from surgery, decreasing complication and hospital length of stay.2 The 
pathway for enhanced recovery targets improving 3 factors that have been associated with 
increased hospital length of stay and complications. These factors are pain, immobilization and 
postoperative ileus. These factors, many times are inter-related. A patient in pain would tend not 
to ambulate as this may exacerbate the pain and discomfort. In order to alleviate pain, the patient 
would most likely receive an opioid for pain management and these medications are known to 
have undesirable side effects such as nausea, vomiting, sedation, respiratory depression, 
constipation and urinary retention. All of these adverse effects (AEs) may lead to complications 
or increased hospital length of stay. 
To the best of our knowledge the average level of physical activity (PA) of parturients 
recovering from a cesarean delivery or after a normal spontaneous vaginal delivery (NSVD) 
remains unknown. Taking in consideration that parturients are in a hypercoagulable state and that 
obstetric venous thromboembolism (VT) is one of the most common causes of maternal 
morbidity and mortality, ambulation is of utmost importance to anesthesiologists as well as 
obstetricians.3,4 In order to promote mobility, first we need to learn the average parturients level 
of physical actity in the immediate post-partum period and up to 48 hours after delivery.  This 
information may help us promote mobility in the immediate postpartum period, particularly for 
those that underwent a cesarean delivery since they are at higher risk of VT.4  

Title: A Pilot Study: To compare physical activity after a normal spontaneous or cesarean delivery by use of a Actigraph GT3X 
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Given the lack of knowledge regarding the physical activity level of parturients in the postpartum 
period we have designed a pilot study to objectively measure their PA. Patients having a normal 
spontaneous vaginal delivery will serve as our control group. These patients are going through 
the same physiologyic changes that their counterparts (CD patients) are going through, the only 
difference being the stress of surgery in the CD group.The use of Fitness trackers (i.e Fitbit(R), 
Actigraph GT3X +) has been used to measure and promote physical activity in a cardiac 
rehabilitation population, as well as in parturients self-identified as inactive.5,6 We intend to use 
the Actigraph GT3X+ to measure the level of physical activity of 50 parturients (25 NSVD and 
25 post CD). The information obtained, we expect, will help us tailor the anesthetic/analgesic 
management of parturients in such a way that promotes early ambulation and recovery. We 
estimate that we need approximately a total of 50 patients, 25 per group to assess if there is a 
difference in the level of PA between parturients after a NSVD or CD. We will aim to recruit 60 
patients per group to account for missing data, protocol violations, equipment malfunction or 
patients drop outs. 
3. Research Design and Methods
This will be a multicenter pilot, prospective study aimed at measuring the physical activity 
(PA) of American Society of Anesthesiologists (ASA) Classification I and II women aged 
18 years and older, after a normal spontaneous vaginal (NSVD) or cesarean delivery (CD). 
Subjects will be ASA I and II women aged 18 years and older, knowing to have had either 
a NSVD or CD (under neuraxial anesthesia). After delivery, and assuring that mother and 
baby are stable, patients will be approached by a member of the study team to discuss 
the study and obtain informed consent. After obtaining informed consent, patients will be 
divided into Two (2) groups depending on the mode of delivery. Group 1 will be NSVD 
and group 2 will be CD patients. Patients will be provided with a fitbit- based Actigraph 
GT3X + hardware, 6 hours after delivery. Patients will be evaluated every 12 hours after 
delivery for a period of 48 hours. During these evaluation points, pain (visual analogue 
scores), factors affecting mobility, and level of satisfaction with their analgesia will be 
assesed. After 48 hrs the Actigraph GT3X + will be interrogated and objective data, such 
as mean daily steps and daily MET min-1, will be obtained using the aforementioned 
software. 
3.1. Duration of Study 
One year 
3.2 Study Sites: 
       University Hospital-Newark, New Jersey 

Title: A Pilot Study: To compare physical activity after a normal spontaneous or cesarean delivery by use of a Actigraph GT3X 
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The George Washington University School of Medicine and Health Sciences,        Washington 
DC 
Yale, New Haven Hospital  
3.3 Sample Size Justification  
This study has been designed as a pilot study.  Sixty subjects will be enrolled to account 
for subject withdrawal, lost data, protol violation.  The investigators plan to analyze 50 
subjects (25/per group ). 
3.4 Subject Selection and Enrollment Considerations 
The study subjects will be American Society of Anesthesiologists (ASA) classification  I 
and II women aged 18 years and older, knowing to have had either a NSVD or CD using 
a neuraxial analgesia/anesthesia technique. 
3.5.1 Inclusion Criteria 
The study subjects will be ASA I and II women aged 18 years and older, knowing to have 
had either a NSVD or CD using a neuraxial analgesia/anesthesia technique. 
 3.5.2 Exclusion Criteria 
History of chronic pain  
Recent use of opioids (other than postpartum) 
Emergency case requiring general anesthesia (GA) or conversion to GA  
BMI > 45 
Need to perform more extensive surgery (i.e Hysterectomy) 
Need for the neonate to be admitted to NICU (This will prompt mothers to walk 
more frequently, and longer distances to visit the baby) 
3.5.3 Subject Recruitment  
Patients will be recruited after a known NSVD or CD. Patients will be approached after 
assuring that both the parturient and the neonate are stable. The patient will be recruited 
within the first 6 hrs after delivery. 
3.5.4 Consent Procedures 
Informed consent will be obtained by one of the investigators after assuring 
maternal and fetal wellbeing. The parturient will be approached within the first 
two to six hours after delivery. A thorough explanation of the protocol will be 
given by one of the investigators. 
3.5.5 Subject Costs and Compensation 
Subjects will not be compensated for their participation in the study. 
3.6 Chart Review Selection 
The study data will be collected from the subject as well as a review of the subjects Medication 
Administration documents found  in EPIC.  
4.
Study Variables

Title: A Pilot Study: To compare physical activity after a normal spontaneous or cesarean delivery by use of a Actigraph GT3X 
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4.1 Independent Variables or Interventions 
Independent variables: Demographic and labor data (patient age, ethnicity, height, 
weight, body mass index (BMI), gravity, parity, time of delivery, mode of anesthesia 
or analgesia, mode of delivery, post-partum analgesia (iv or po analgesia), number 
of previous CD and prior abdominal surgery). 
Interventions: After obtaining informed consent, patients will be assigned to either 
the NSVD or CD group. Patients will be provided with a fitbit- based Actigraph GT3X 
+ hardware, 6 hours after delivery. Physical activity will be objectively measured
using the Actilife software and fitbit- based Actigraph GT3X + hardware. Physical
activity will be measured as mean daily steps and daily MET min-1. This data will be
obtained at 48 hours after NSVD or CD and will be compared at the 12 hour, 24
hour, 36 hour, and 48 hour time points.
4.1.1 Drug or Device Interventions 
The Actigraph GT3X-BT (Actigraph, Florida, US) is an accelerometer that assesses total 
body displacement across a vertical plane and determines physical activity levels in the 
form of activity and step counts. This device has been previously validated.7 
4.2 Dependent Variables or Outcome Measures 
Dependent variables: Factors contributing to immobility (i.e foley catheter), pain 
scores at rest and with movement will be measured using VAS scores, medications 
administered and satisfaction with analgesia will be monitored every 12 h for 48 h.  
Outcome measures:  
       Primary: mean average steps and MET min-1 
      Secondary: Pain and satisfaction scores 
4.3 Risk of Harm  
This study does not involve any potential risk to the patient. The patients will simply be 
asked to wear a wrist fitbit-based accelerometer (Actigraph GT3X-BT). At most, it is 
possible that some patients may develop a rash or mild skin reaction to the wrist band of the 
aforementioned device. 
4.4 Potential for Benefit 
The potential benefit from participating in this study includes helping physician to gain 
knowledge as to the physical activity of parturients immediately postpartum. The knowledge 
gained may help us tailor our analgesic strategies or simply encourage the parturient to 
increase their physical activity, particularly after CD as those patients are at higher risk for 
thromboembolic events. 
4. Data Handling and Statistical Analysis
The study data will be collected on the data collection form. Subjects will be assigned a code
consisting of a number and letters designating the  mode of delivery, the first subject at Rutgers

Title: A Pilot Study: To compare physical activity after a normal spontaneous or cesarean delivery by use of a Actigraph GT3X 
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New Jersey Medical School 1RNJMS-CD or 1RNJMS-NSVD). The first page of the data 
collection form, which contains limited protected health information (patient name, MRN) will 
be kept until all data is gathered, then the form will be de-identified by destroying the first page, 
saving only the subject number. All forms will be securely kept in a locked cabinet in the locked 
office of the principal investigator at each participating institution. All digital data stored on 
computers will be on encrypted drives. Only study team participants will have access to the 
collected data.  
There are no specific privacy issues beyond the confidentiality of study data as described above. 
This will be a pilot prospective study, in which objective physical activity (measured as mean 
daily steps and daily MET min-1) will be the main primary outcome. Given that this is a pilot 
study, we estimate that we need approximately a total of 50 patients, 25 per group to assess if 
there is a difference in the level of PA between parturients after a NSVD or CD. We will aim 
to recruit 60 patients total to account for missing data, protocol violations, equipment 
malfunction or patients drop outs.   
ANOVA will be used to study variablilty between groups. Kruskal Wallis will be used for 
averages.  
7. Reporting Results
7.1 Individual Results
Expressed in terms of average and standard deviation.
7.2 Aggregate Results
7.3 Professional Reporting 
Results maybe presented at one or more of the following Annual Meetings the American 
Society of Anesthesiologists, International Anesthesia Research Society, the Society of 
Obseterics and Perinatology.  Journal publication may include Anesthesiology or Anesthesia 
and Analgesia. 
8. Bibliography
1. Blanchette H. The Rising Cesarean Delivery Rate in America: What Are the Consequences?
Obstetrics and gynecology 2011;118:687–90. Available at:
http://journals.lww.com/greenjournal/Fulltext/2011/09000/The_Rising_Cesarean_Delivery_Rate
_in_America__What.28.aspx.
2. Varadhan KK, Neal KR, Dejong CHC, Fearon KCH, Ljungqvist O, Lobo DN. The enhanced
recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal
surgery: a meta-analysis of randomized controlled trials. Clinical nutrition (Edinburgh, Scotland)
2010;29:434–40. Available at:
http://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pubmed&amp;id=20116145&amp;
retmode=ref&amp;cmd=prlinks.

Title: A Pilot Study: To compare physical activity after a normal spontaneous or cesarean delivery by use of a Actigraph GT3X 
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3. Gonzalez-Fiol A, Eisenberger A. Anesthesia implications of coagulation and anticoagulation
during pregnancy. Seminars in perinatology 2014;38:370–7. Available at:
http://linkinghub.elsevier.com/retrieve/pii/S0146000514000767.
4. D’Alton ME, Friedman AM, Smiley RM, Montgomery DM, Paidas MJ, D’Oria R, Frost JL,
Hameed AB, Karsnitz D, Levy BS, Clark SL. National Partnership for Maternal Safety:
Consensus Bundle on Venous Thromboembolism. 2016;123:942–9. Available at:
http://content.wkhealth.com/linkback/openurl?sid=WKPTLP:landingpage&an=00000539-
201610000-00021.
5. Alharbi M, Bauman A, Neubeck L, Gallagher R. Validation of Fitbit-Flex as a measure of
free-living physical activity in a community-based phase III cardiac rehabilitation population.
European journal of preventive cardiology 2016;23:1476–85. Available at:
http://cpr.sagepub.com/content/23/14/1476.full.
6. Huberty JL, Buman MP, Leiferman JA, Bushar J, Adams MA. Trajectories of objectively-
measured physical activity and sedentary time over the course of pregnancy in women self-
identified as inactive. Preventive Medicine Reports 2016;3:353–60. Available at:
http://linkinghub.elsevier.com/retrieve/pii/S2211335516300237.
7. Harrison CL, Thompson RG, Teede HJ, Lombard CB. Measuring physical activity during
pregnancy. The international journal of behavioral nutrition and physical activity 2011;8:19.
Available at: http://ijbnpa.biomedcentral.com/articles/10.1186/1479-5868-8-19.