Trial Outcomes & Findings for Mobius® Post-cesarean Pain Randomized Control Trial (NCT NCT00685932)
NCT ID: NCT00685932
Last Updated: 2018-04-18
Results Overview
Visual analog scale (VAS) of pain with activity on a scale of 0-15cm with 0cm: No pain to 15cm: Severe pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
154 participants
Primary outcome timeframe
2 days
Results posted on
2018-04-18
Participant Flow
July 2008 to March 2010
Participant milestones
| Measure |
Control
Conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
|
Mobius
Subjects underwent cesarean delivery and the Mobius self-retaining retractor was used as the primary method of retraction during hysterotomy, delivery of infant, hysterotomy repair as well as inspection and irrigation. Other conventional retraction was used for the remainder of the procedure as needed. Decision to abandon use of the Mobius was at the discretion of the primary surgeon.
|
|---|---|---|
|
Overall Study
STARTED
|
76
|
78
|
|
Overall Study
COMPLETED
|
55
|
58
|
|
Overall Study
NOT COMPLETED
|
21
|
20
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobius® Post-cesarean Pain Randomized Control Trial
Baseline characteristics by cohort
| Measure |
Control
n=76 Participants
This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
|
Mobius
n=78 Participants
This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
|
Total
n=154 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
76 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
30.3 years
STANDARD_DEVIATION 5.3 • n=7 Participants
|
30.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
76 Participants
n=5 Participants
|
78 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
76 participants
n=5 Participants
|
78 participants
n=7 Participants
|
154 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 daysVisual analog scale (VAS) of pain with activity on a scale of 0-15cm with 0cm: No pain to 15cm: Severe pain.
Outcome measures
| Measure |
Control
n=76 Participants
This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
|
Mobius
n=78 Participants
This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
|
|---|---|---|
|
The Degree of Pain With Activity on Post-operative Day Number Two
|
6.4 cm
Standard Deviation 3.0
|
6.3 cm
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: 2 days post-operationVisual analog scale will be used to assess pain on the right or left side of the body with activity.VAS will use a 0-7.5cm range on the right and 0-7.5cm range on the left. This scale is with 0 (or central mark) as no pain and increasing as the subject marks away from the central mark.
Outcome measures
| Measure |
Control
n=76 Participants
This arm will be randomly assigned to have conventional retractions (ie Rich retractors and similar) used in the usual fashion during the cesarean procedure.
|
Mobius
n=78 Participants
This arm will be randomized to have the providers who are performing the cesarean section use the Mobius retractor during the cesarean section procedure after the peritoneal cavity is opened.
|
|---|---|---|
|
Number of Participants Who Report Asymmetrical Pain on Second Post-operative Day After Cesarean Delivery
|
33 participants
|
32 participants
|
Adverse Events
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mobius
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
Abbey Hardy-Fairbank, MD
University of Iowa Hospitals and Clinics
Phone: 319-356-2291
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place