Physical Activity After a Normal Spontaneous or Cesarean Delivery

• Sponsor: Rutgers, The State University of New Jersey (Other)
• Overall Status: Completed
• CT.gov ID: NCT02967016
• Collaborator: George Washington University (Other)
• Enrollment: 50
• Locations: 2
• Arms: 2
• Actual Duration (Months): 28.9
• Patients Per Site: 25
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

To the best of the investigators 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. In order to promote mobility, first the investigators need to learn the average parturients level of physical activity 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.

Condition or Disease	Intervention/Treatment	Phase
Postpartum Disorder	Behavioral: Actigraph	N/A

Detailed Description

Cesarean delivery is the most common surgery performed in the United States. 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. 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 the investigators 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. In order to promote mobility, first we need to learn the average parturients level of physical acuity 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.

Given the lack of knowledge regarding the physical activity level of parturients in the postpartum period, the investigators 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 physiologic 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. The investigators 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, will help us tailor the anesthetic/analgesic management of parturients in such a way that promotes early ambulation and recovery. The investigators 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 30 per group to account for missing data, protocol violations, equipment malfunction or patients drop outs.This will be a 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, 3 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 assessed. After 48 hours the Actigraph GT3X + will be interrogated and objective data, such as mean daily steps, will be obtained using the aforementioned software.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: A Pilot Study: To Compare Physical Activity After a Normal Spontaneous or Cesarean Delivery by Use of a Actigraph GT3X
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Jul 30, 2019
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: normal spontaneous vaginal delivery Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).	Behavioral: Actigraph; following delivery a ActiGraph will be offered to patients to track their steps
Experimental: Cesarean Delivery Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).	Behavioral: Actigraph; following delivery a ActiGraph will be offered to patients to track their steps

Outcome Measures

Primary Outcome Measures

1. Steps [from 6 hours the after delivery until discharge or 48 hours whatever happens first]

   This will be measured in the numbers of steps registered by the accelerometer

Secondary Outcome Measures

1. Pain Score at Rest [6 hours following delivery until 48 hours]

   This outcome will be measured using a visual analogue score (VAS). Patient will mark their pain on a 0-100 mm line with 0 been no pain and 100 mm worst pain.

2. Satisfaction Scores [6 hours following delivery until 48 hours]

   This outcome will be measured using a visual analogue score (VAS). Patient will mark their satisfaction on a 0-100 mm line with 0 been not satisfied at all and 100 mm extremely satisfied.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women 18-45 years old giving birth after receiving a neuraxial analgesia/anesthesia technique. American Society of Anesthesiologists classification 1-2.

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	George Washington University	Washington	District of Columbia	United States	20037
2	University Hospital	Newark	New Jersey	United States	07103

Sponsors and Collaborators

• Rutgers, The State University of New Jersey
• George Washington University

Investigators

• Study Director: Antonio Gonzalez-Fiol, MD, Yale New Haven Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 12, 2020

More Information

Publications

None provided.

• Responsible Party: Dongchen Li, MD, Assistant Professor Director of Obstetric Anesthesia Department of Anesthesiology, Rutgers, The State University of New Jersey
• ClinicalTrials.gov Identifier: NCT02967016
• Other Study ID Numbers: 20160001283
• First Posted: Nov 17, 2016
• Last Update Posted: Jun 19, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Puerperal Disorders

Study Results

Participant Flow

Arm/Group Title	Normal Spontaneous Vaginal Delivery	Cesarean Delivery
Arm/Group Description	Both groups will be asked to wear a fitness tracker (Actigraph GT3X+). Actigraph: following delivery a ActiGraph will be offered to patients to track their steps	Both groups will be asked to wear a fitness tracker (Actigraph GT3X+). Actigraph: following delivery a ActiGraph will be offered to patients to track their steps
Period Title: Overall Study
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Cesarean Delivery	Vaginal Delivery	Total
Arm/Group Description	Patients delivered via cesarean section	Patients delivery via cesarean delivery	Total of all reporting groups
Overall Participants	25	25	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	31.6 (5.9)	28.3 (6.0)	30.0 (6.1)
Sex: Female, Male (Count of Participants)
Female	25 100%	25 100%	50 100%
Male	0 0%	0 0%	0 0%
Race/Ethnicity, Customized (Count of Participants)
Black	10 40%	14 56%	24 48%
White	10 40%	9 36%	19 38%
Asian	0 0%	1 4%	1 2%
Other	4 16%	1 4%	5 10%
Not available	1 4%	0 0%	1 2%
Body Mass index (Kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m2]	32 (6.3)	31.4 (6.0)	31.7 (6.1)

Outcome Measures

1. Primary Outcome

Title	Steps
Description	This will be measured in the numbers of steps registered by the accelerometer
Time Frame	from 6 hours the after delivery until discharge or 48 hours whatever happens first

Outcome Measure Data

Analysis Population Description

steps

Arm/Group Title	Cesarean Delivery	Vaginal Delivery
Arm/Group Description	Patients delivered via cesarean section	Patients delivery via cesarean delivery
Measure Participants	25	25
6	968 (920)	1771 (660)
12	1652 (1206)	3165 (1266)
24	3421 (2314)	5911 (2162)
36	4919 (3678)	8841 (3113)
48	6306 (5835)	9813 (3916)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Cumulative Steps 6 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Cumulative steps 12 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.0002
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Cumulative steps 24 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.0006
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Cumulative steps 36 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0006
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Cumulative steps 48 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.03
	Comments
	Method	Kruskal-Wallis
	Comments

2. Secondary Outcome

Title	Pain Score at Rest
Description	This outcome will be measured using a visual analogue score (VAS). Patient will mark their pain on a 0-100 mm line with 0 been no pain and 100 mm worst pain.
Time Frame	6 hours following delivery until 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cesarean Delivery	Vaginal Delivery
Arm/Group Description	Patients delivered via cesarean section	Patients delivery via cesarean delivery
Measure Participants	25	25
6	25 (24)	14 (18)
12	27 (23)	22 (24)
24	28 (22)	13 (18)
36	36 (22)	15 (19)
48	23 (19)	12 (17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Pain at rest 6 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.06
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Pain at rest 12 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.30
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Pain at rest 24 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.002
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Pain at rest 36 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Pain at rest at 48 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.02
	Comments
	Method	Kruskal-Wallis
	Comments

3. Secondary Outcome

Title	Satisfaction Scores
Description	This outcome will be measured using a visual analogue score (VAS). Patient will mark their satisfaction on a 0-100 mm line with 0 been not satisfied at all and 100 mm extremely satisfied.
Time Frame	6 hours following delivery until 48 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cesarean Delivery	Vaginal Delivery
Arm/Group Description	Patients delivered via cesarean section	Patients delivery via cesarean delivery
Measure Participants	25	25
6	71 (34)	78 (31)
12	69 (29)	80 (28)
24	60 (32)	83 (30)
36	58 (29)	95 (13)
48	57 (32)	89 (27)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Satisfaction with pain control 6 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.43
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Satisfaction with pain control 12 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.24
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Satisfaction with pain control 24 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.012
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Satisfaction with pain control 36 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Kruskal-Wallis
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Cesarean Delivery, Vaginal Delivery
	Comments	Satisfaction with pain control 48 h
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	.0005
	Comments
	Method	Kruskal-Wallis
	Comments

Adverse Events

Time Frame	3 months
Arm/Group Title	Normal Spontaneous Vaginal Delivery		Cesarean Delivery
Arm/Group Description	Both groups will be asked to wear a fitness tracker (Actigraph GT3X+). Actigraph: following delivery a ActiGraph will be offered to patients to track their steps		Both groups will be asked to wear a fitness tracker (Actigraph GT3X+). Actigraph: following delivery a ActiGraph will be offered to patients to track their steps
All Cause Mortality
	Normal Spontaneous Vaginal Delivery		Cesarean Delivery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Serious Adverse Events
	Normal Spontaneous Vaginal Delivery		Cesarean Delivery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	Normal Spontaneous Vaginal Delivery		Cesarean Delivery
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/25 (0%)		0/25 (0%)

Limitations/Caveats

Small sample size. No standardized post-delivery ambulation protocol at any of the institutions.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.