Skip to content

Physical Activity After a Normal Spontaneous or Cesarean Delivery

A Pilot Study: To Compare Physical Activity After a Normal Spontaneous or Cesarean Delivery by Use of a Actigraph GT3X

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02967016
Enrollment
50
Registered
2016-11-17
Start date
2017-04-01
Completion date
2019-08-30
Last updated
2020-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postpartum Disorder

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.

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.

Interventions

BEHAVIORALActigraph

following delivery a ActiGraph will be offered to patients to track their steps

Sponsors

George Washington University
CollaboratorOTHER
Rutgers, The State University of New Jersey
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
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)

Design outcomes

Primary

MeasureTime frameDescription
Stepsfrom 6 hours the after delivery until discharge or 48 hours whatever happens firstThis will be measured in the numbers of steps registered by the accelerometer

Secondary

MeasureTime frameDescription
Pain Score at Rest6 hours following delivery until 48 hoursThis 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.
Satisfaction Scores6 hours following delivery until 48 hoursThis 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Cesarean Delivery
Patients delivered via cesarean section
25
Vaginal Delivery
Patients delivery via cesarean delivery
25
Total50

Baseline characteristics

CharacteristicCesarean DeliveryVaginal DeliveryTotal
Age, Continuous31.6 years
STANDARD_DEVIATION 5.9
28.3 years
STANDARD_DEVIATION 6
30.0 years
STANDARD_DEVIATION 6.1
Body Mass index32 Kg/m2
STANDARD_DEVIATION 6.3
31.4 Kg/m2
STANDARD_DEVIATION 6
31.7 Kg/m2
STANDARD_DEVIATION 6.1
Race/Ethnicity, Customized
Asian
0 Participants1 Participants1 Participants
Race/Ethnicity, Customized
Black
10 Participants14 Participants24 Participants
Race/Ethnicity, Customized
Not available
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Other
4 Participants1 Participants5 Participants
Race/Ethnicity, Customized
White
10 Participants9 Participants19 Participants
Sex: Female, Male
Female
25 Participants25 Participants50 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 25
other
Total, other adverse events
0 / 250 / 25
serious
Total, serious adverse events
0 / 250 / 25

Outcome results

Primary

Steps

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

Population: steps

ArmMeasureGroupValue (MEAN)Dispersion
Cesarean DeliverySteps121652 StepsStandard Deviation 1206
Cesarean DeliverySteps364919 StepsStandard Deviation 3678
Cesarean DeliverySteps243421 StepsStandard Deviation 2314
Cesarean DeliverySteps486306 StepsStandard Deviation 5835
Cesarean DeliverySteps6968 StepsStandard Deviation 920
Vaginal DeliverySteps489813 StepsStandard Deviation 3916
Vaginal DeliverySteps61771 StepsStandard Deviation 660
Vaginal DeliverySteps123165 StepsStandard Deviation 1266
Vaginal DeliverySteps245911 StepsStandard Deviation 2162
Vaginal DeliverySteps368841 StepsStandard Deviation 3113
Comparison: Cumulative Steps 6 hp-value: 0.002Kruskal-Wallis
Comparison: Cumulative steps 12 hp-value: 0.0002Kruskal-Wallis
Comparison: Cumulative steps 24 hp-value: 0.0006Kruskal-Wallis
Comparison: Cumulative steps 36 hp-value: 0.0006Kruskal-Wallis
Comparison: Cumulative steps 48 hp-value: 0.03Kruskal-Wallis
Secondary

Pain Score at Rest

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

ArmMeasureGroupValue (MEAN)Dispersion
Cesarean DeliveryPain Score at Rest1227 score on a scale (0-100)Standard Deviation 23
Cesarean DeliveryPain Score at Rest3636 score on a scale (0-100)Standard Deviation 22
Cesarean DeliveryPain Score at Rest2428 score on a scale (0-100)Standard Deviation 22
Cesarean DeliveryPain Score at Rest4823 score on a scale (0-100)Standard Deviation 19
Cesarean DeliveryPain Score at Rest625 score on a scale (0-100)Standard Deviation 24
Vaginal DeliveryPain Score at Rest4812 score on a scale (0-100)Standard Deviation 17
Vaginal DeliveryPain Score at Rest614 score on a scale (0-100)Standard Deviation 18
Vaginal DeliveryPain Score at Rest1222 score on a scale (0-100)Standard Deviation 24
Vaginal DeliveryPain Score at Rest2413 score on a scale (0-100)Standard Deviation 18
Vaginal DeliveryPain Score at Rest3615 score on a scale (0-100)Standard Deviation 19
Comparison: Pain at rest 6 hp-value: 0.06Kruskal-Wallis
Comparison: Pain at rest 12 hp-value: 0.3Kruskal-Wallis
Comparison: Pain at rest 24 hp-value: 0.002Kruskal-Wallis
Comparison: Pain at rest 36 hp-value: 0.003Kruskal-Wallis
Comparison: Pain at rest at 48 hp-value: 0.02Kruskal-Wallis
Secondary

Satisfaction Scores

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

ArmMeasureGroupValue (MEAN)Dispersion
Cesarean DeliverySatisfaction Scores1269 score on a scale (0-100)Standard Deviation 29
Cesarean DeliverySatisfaction Scores3658 score on a scale (0-100)Standard Deviation 29
Cesarean DeliverySatisfaction Scores2460 score on a scale (0-100)Standard Deviation 32
Cesarean DeliverySatisfaction Scores4857 score on a scale (0-100)Standard Deviation 32
Cesarean DeliverySatisfaction Scores671 score on a scale (0-100)Standard Deviation 34
Vaginal DeliverySatisfaction Scores4889 score on a scale (0-100)Standard Deviation 27
Vaginal DeliverySatisfaction Scores678 score on a scale (0-100)Standard Deviation 31
Vaginal DeliverySatisfaction Scores1280 score on a scale (0-100)Standard Deviation 28
Vaginal DeliverySatisfaction Scores2483 score on a scale (0-100)Standard Deviation 30
Vaginal DeliverySatisfaction Scores3695 score on a scale (0-100)Standard Deviation 13
Comparison: Satisfaction with pain control 6 hp-value: 0.43Kruskal-Wallis
Comparison: Satisfaction with pain control 12 hp-value: 0.24Kruskal-Wallis
Comparison: Satisfaction with pain control 24 hp-value: 0.012Kruskal-Wallis
Comparison: Satisfaction with pain control 36 hp-value: <0.0001Kruskal-Wallis
Comparison: Satisfaction with pain control 48 hp-value: 0.0005Kruskal-Wallis

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026