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Postpartum DisorderNCT02967016

Physical Activity After a Normal Spontaneous or Cesarean Delivery

A study testing Actigraph in people with Postpartum Disorder, run by Rutgers, The State University of New Jersey at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Postpartum Disorder
What is being tested?
Actigraph
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
2 sitesUnited States
Study dates
1 Apr 2017to 30 Aug 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University Hospital

    Newark, New Jersey, 07103

  • George Washington University

    Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Actigraph
Medical subject headings
Puerperal Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ActigraphBehavioural

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

Study groups in NCT02967016
Study groupRoleWhat they receive
normal spontaneous vaginal deliveryExperimentalBoth groups will be asked to wear a fitness tracker (Actigraph GT3X+).
Receives: Behavioral: Actigraph
Cesarean DeliveryExperimentalBoth groups will be asked to wear a fitness tracker (Actigraph GT3X+).
Receives: Behavioral: Actigraph

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Steps

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

    Measured: from 6 hours the after delivery until discharge or 48 hours whatever happens first

Secondary outcomes (2)
  1. 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.

    Measured: 6 hours following delivery until 48 hours

  2. 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.

    Measured: 6 hours following delivery until 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2016 (estimated)
  2. Study start1 Apr 2017
  3. Primary completion30 Jul 2019
  4. Study completion30 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02967016
Sponsor's protocol ID
20160001283
Status last verified
Jun 2020
First submitted
28 Oct 2016
Last updated
19 Jun 2020
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Actigraph in people with Postpartum Disorder, run by Rutgers, The State University of New Jersey at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Steps (time frame: from 6 hours the after delivery until discharge or 48 hours whatever happens first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.

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