Clinical Trial: Physical Activity After a Normal Spontaneous or Cesarean Delivery

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary:

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.

Sponsor: Rutgers, The State University of New Jersey

Current Primary Outcome: mean average steps [ Time Frame: from 6 hours the after delivery until discharge or 48 hours whatever happens first ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Pain Score [ Time Frame: 12 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.
• satisfaction scores [ Time Frame: 12 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.
• MET min-1 [ Time Frame: from 6 hours the after delivery until discharge or 48 hours whatever happens first ]

Original Secondary Outcome: Same as current

Information By: Rutgers, The State University of New Jersey

Dates:
Date Received: October 28, 2016
Date Started: November 2016
Date Completion: June 2018
Last Updated: November 23, 2016
Last Verified: November 2016