Trial Outcomes & Findings for A Trial to Reduce Adhesions Following a Primary Cesarean Section (NCT NCT01819467)
NCT ID: NCT01819467
Last Updated: 2023-08-16
Results Overview
Study was terminated due to too many protocol deviations. There were no outcome measures analyzed.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
29 participants
Primary outcome timeframe
21 months
Results posted on
2023-08-16
Participant Flow
Scheduled C-section deliveries
Non-C-section deliveries
Participant milestones
| Measure |
Seprafilm
Patients in this group will receive Seprafilm onto the uterine incision and the anterior midline of the uterus.
Seprafilm: Seprafilm will be placed onto the uterine incision and the anterior midline of the uterus following the primary cesarean section
|
Control
No Seprafilm was placed on to the uterine incision.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
9
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
20
|
9
|
Reasons for withdrawal
| Measure |
Seprafilm
Patients in this group will receive Seprafilm onto the uterine incision and the anterior midline of the uterus.
Seprafilm: Seprafilm will be placed onto the uterine incision and the anterior midline of the uterus following the primary cesarean section
|
Control
No Seprafilm was placed on to the uterine incision.
|
|---|---|---|
|
Overall Study
Physician Decision
|
20
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Seprafilm
n=20 Participants
Pregnant females age 12 and over who underwent a C-Section and Seprafilm was placed on the uterine incision.
|
Control
n=9 Participants
Did not receive Seprafilm on uterine incision.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=29 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=20 Participants
|
9 Participants
n=9 Participants
|
29 Participants
n=29 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=29 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=20 Participants
|
9 Participants
n=9 Participants
|
29 Participants
n=29 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=29 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 21 monthsPopulation: No data for pre-specified Primary and Secondary Outcome Measures were collected.
Study was terminated due to too many protocol deviations. There were no outcome measures analyzed.
Outcome measures
Outcome data not reported
Adverse Events
Seprafilm Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
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