Physical Activity After a Normal Spontaneous or Cesarean Delivery



Status:Recruiting
Healthy:No
Age Range:18 - 45
Updated:11/10/2018
Start Date:April 1, 2017
End Date:August 2019
Contact:Antonio Gonzalez-Fiol, MD
Email:antonio.gonzalez-fiol@yale.edu
Phone:973 972 5007

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

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.

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.

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)
We found this trial at
2
sites
Washington, District of Columbia 20052
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Newark, New Jersey 07103
Principal Investigator: Li Dongchen, MD
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Newark, NJ
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