Postpartum Disorder Clinical Trial
Official title:
A Pilot Study: To Compare Physical Activity After a Normal Spontaneous or Cesarean Delivery by Use of a Actigraph GT3X
Verified date | June 2020 |
Source | Rutgers, The State University of New Jersey |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 30, 2019 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | University Hospital | Newark | New Jersey |
United States | George Washington University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Rutgers, The State University of New Jersey | George Washington University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Steps | This will be measured in the numbers of steps registered by the accelerometer | from 6 hours the after delivery until discharge or 48 hours whatever happens first | |
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. | 6 hours following delivery until 48 hours | |
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. | 6 hours following delivery until 48 hours |
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