An interventional study of Actigraph in Postpartum Disorder, sponsored by Rutgers, The State University of New Jersey. Completed at 2 sites in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2020-06-19.
Sponsored by Rutgers, The State University of New Jersey · Not applicable, Interventional, and Prevention
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.
40 studies on the registry are indexed under Puerperal Disorders; 10 are open to participants now.
This study's enrollment of 50 is below the median of 81 across 32 interventional studies indexed under Puerperal Disorders.
Browse Puerperal Disorders studies →Rutgers, The State University of New Jersey is the lead sponsor of 506 studies on the registry; 131 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 31 (79%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).
Behavioral: Actigraph
Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).
Behavioral: Actigraph
following delivery a ActiGraph will be offered to patients to track their steps
Steps
This will be measured in the numbers of steps registered by the accelerometer
Time frame: from 6 hours the after delivery until discharge or 48 hours whatever happens first
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.
Time frame: 6 hours following delivery until 48 hours
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.
Time frame: 6 hours following delivery until 48 hours
| Milestone | Normal Spontaneous Vaginal Delivery | Cesarean Delivery |
|---|---|---|
| Started | 25 | 25 |
| Completed | 25 | 25 |
| Not completed | 0 | 0 |
This will be measured in the numbers of steps registered by the accelerometer
| Steps | Cesarean Delivery | Vaginal Delivery |
|---|---|---|
| 6 | 968 ± 920 | 1771 ± 660 |
| 12 | 1652 ± 1206 | 3165 ± 1266 |
| 24 | 3421 ± 2314 | 5911 ± 2162 |
| 36 | 4919 ± 3678 | 8841 ± 3113 |
| 48 | 6306 ± 5835 | 9813 ± 3916 |
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.
| score on a scale (0-100) | Cesarean Delivery | Vaginal Delivery |
|---|---|---|
| 6 | 25 ± 24 | 14 ± 18 |
| 12 | 27 ± 23 | 22 ± 24 |
| 24 | 28 ± 22 | 13 ± 18 |
| 36 | 36 ± 22 | 15 ± 19 |
| 48 | 23 ± 19 | 12 ± 17 |
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.
| score on a scale (0-100) | Cesarean Delivery | Vaginal Delivery |
|---|---|---|
| 6 | 71 ± 34 | 78 ± 31 |
| 12 | 69 ± 29 | 80 ± 28 |
| 24 | 60 ± 32 | 83 ± 30 |
| 36 | 58 ± 29 | 95 ± 13 |
| 48 | 57 ± 32 | 89 ± 27 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Normal Spontaneous Vaginal Delivery | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Cesarean Delivery | 0/25 (0%) | 0/25 (0%) | 0/25 (0%) |
| Age, Continuous(years) | Cesarean Delivery | Vaginal Delivery | Total |
|---|---|---|---|
| Mean | 31.6 ± 5.9 | 28.3 ± 6.0 | 30.0 ± 6.1 |
| Sex: Female, Male(Participants) | Cesarean Delivery | Vaginal Delivery | Total |
|---|---|---|---|
| Female | 25 | 25 | 50 |
| Male | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Cesarean Delivery | Vaginal Delivery | Total |
|---|---|---|---|
| Black | 10 | 14 | 24 |
| White | 10 | 9 | 19 |
| Asian | 0 | 1 | 1 |
| Other | 4 | 1 | 5 |
| Not available | 1 | 0 | 1 |
| Body Mass index(Kg/m2) | Cesarean Delivery | Vaginal Delivery | Total |
|---|---|---|---|
| Mean | 32 ± 6.3 | 31.4 ± 6.0 | 31.7 ± 6.1 |
PDFs hosted by the registry, ClinicalTrials.gov.
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