Trial Outcomes & Findings for Physical Activity After a Normal Spontaneous or Cesarean Delivery (NCT NCT02967016)
NCT ID: NCT02967016
Last Updated: 2020-06-19
Results Overview
This will be measured in the numbers of steps registered by the accelerometer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
from 6 hours the after delivery until discharge or 48 hours whatever happens first
Results posted on
2020-06-19
Participant Flow
Participant milestones
| Measure |
Normal Spontaneous Vaginal Delivery
Both groups will be asked to wear a fitness tracker (Actigraph GT3X+).
Actigraph: 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+).
Actigraph: following delivery a ActiGraph will be offered to patients to track their steps
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Physical Activity After a Normal Spontaneous or Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Cesarean Delivery
n=25 Participants
Patients delivered via cesarean section
|
Vaginal Delivery
n=25 Participants
Patients delivery via cesarean delivery
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.6 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
28.3 years
STANDARD_DEVIATION 6.0 • n=7 Participants
|
30.0 years
STANDARD_DEVIATION 6.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
10 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
10 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not available
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Body Mass index
|
32 Kg/m2
STANDARD_DEVIATION 6.3 • n=5 Participants
|
31.4 Kg/m2
STANDARD_DEVIATION 6.0 • n=7 Participants
|
31.7 Kg/m2
STANDARD_DEVIATION 6.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: from 6 hours the after delivery until discharge or 48 hours whatever happens firstPopulation: steps
This will be measured in the numbers of steps registered by the accelerometer
Outcome measures
| Measure |
Cesarean Delivery
n=25 Participants
Patients delivered via cesarean section
|
Vaginal Delivery
n=25 Participants
Patients delivery via cesarean delivery
|
|---|---|---|
|
Steps
6
|
968 Steps
Standard Deviation 920
|
1771 Steps
Standard Deviation 660
|
|
Steps
12
|
1652 Steps
Standard Deviation 1206
|
3165 Steps
Standard Deviation 1266
|
|
Steps
24
|
3421 Steps
Standard Deviation 2314
|
5911 Steps
Standard Deviation 2162
|
|
Steps
36
|
4919 Steps
Standard Deviation 3678
|
8841 Steps
Standard Deviation 3113
|
|
Steps
48
|
6306 Steps
Standard Deviation 5835
|
9813 Steps
Standard Deviation 3916
|
SECONDARY outcome
Timeframe: 6 hours following delivery until 48 hoursThis 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.
Outcome measures
| Measure |
Cesarean Delivery
n=25 Participants
Patients delivered via cesarean section
|
Vaginal Delivery
n=25 Participants
Patients delivery via cesarean delivery
|
|---|---|---|
|
Pain Score at Rest
48
|
23 score on a scale (0-100)
Standard Deviation 19
|
12 score on a scale (0-100)
Standard Deviation 17
|
|
Pain Score at Rest
6
|
25 score on a scale (0-100)
Standard Deviation 24
|
14 score on a scale (0-100)
Standard Deviation 18
|
|
Pain Score at Rest
12
|
27 score on a scale (0-100)
Standard Deviation 23
|
22 score on a scale (0-100)
Standard Deviation 24
|
|
Pain Score at Rest
24
|
28 score on a scale (0-100)
Standard Deviation 22
|
13 score on a scale (0-100)
Standard Deviation 18
|
|
Pain Score at Rest
36
|
36 score on a scale (0-100)
Standard Deviation 22
|
15 score on a scale (0-100)
Standard Deviation 19
|
SECONDARY outcome
Timeframe: 6 hours following delivery until 48 hoursThis 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.
Outcome measures
| Measure |
Cesarean Delivery
n=25 Participants
Patients delivered via cesarean section
|
Vaginal Delivery
n=25 Participants
Patients delivery via cesarean delivery
|
|---|---|---|
|
Satisfaction Scores
6
|
71 score on a scale (0-100)
Standard Deviation 34
|
78 score on a scale (0-100)
Standard Deviation 31
|
|
Satisfaction Scores
48
|
57 score on a scale (0-100)
Standard Deviation 32
|
89 score on a scale (0-100)
Standard Deviation 27
|
|
Satisfaction Scores
12
|
69 score on a scale (0-100)
Standard Deviation 29
|
80 score on a scale (0-100)
Standard Deviation 28
|
|
Satisfaction Scores
24
|
60 score on a scale (0-100)
Standard Deviation 32
|
83 score on a scale (0-100)
Standard Deviation 30
|
|
Satisfaction Scores
36
|
58 score on a scale (0-100)
Standard Deviation 29
|
95 score on a scale (0-100)
Standard Deviation 13
|
Adverse Events
Normal Spontaneous Vaginal Delivery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cesarean Delivery
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place