Physical Activity After a Normal Spontaneous or Cesarean Delivery

NCT ID: NCT02967016

Last Updated: 2020-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2019-08-30

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.

Conditions

Postpartum Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

normal spontaneous vaginal delivery

Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).

Group Type: EXPERIMENTAL

Actigraph

Intervention Type: BEHAVIORAL

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

Cesarean Delivery

Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).

Group Type: EXPERIMENTAL

Actigraph

Intervention Type: BEHAVIORAL

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

Interventions

Actigraph

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

George Washington University

OTHER

Sponsor Role: collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role: lead

Responsible Party

Dongchen Li, MD

Assistant Professor Director of Obstetric Anesthesia Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Antonio Gonzalez-Fiol, MD

Role: STUDY_DIRECTOR

Yale New Haven Hospital

Locations

George Washington University

Washington D.C., District of Columbia, United States

University Hospital

Newark, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20160001283

Identifier Type: -

Identifier Source: org_study_id