Trial Outcomes & Findings for DAISY Uterine Drain Device Evaluation (NCT NCT06219538)
NCT ID: NCT06219538
Last Updated: 2026-05-01
Results Overview
This is a prospective, single-arm, device evaluation study of device use by five (5) obstetrical surgeons placing the drain with low-level suction in up to ten (10) women undergoing elective, non-emergent cesarean delivery. Hemoglobin was measured at two time points: baseline (preoperative) and 1 day post operative. The mean change in hemoglobin concentration between baseline (preoperative) values obtained on the day of surgery and postoperative day 1 was analyzed and compared to historical means in the US in 31 hospitals with 5470 participants.
COMPLETED
NA
10 participants
Day of surgery (preoperative) and one day post procedure
2026-05-01
Participant Flow
Pregnant subjects who were planning a Cesarean Delivery (CD) and had one or more risks for post-partum hemorrhage where enrolled at the care center.
Participant milestones
| Measure |
Single Arm CD Participants
Participants in this single arm study of device use consist of women undergoing planned CD for reasons unrelated to this study and who are qualified based on the Instructions for Use (IFU) and who consent to participation.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Single Arm CD Participants
Participants in this single arm study of device use consist of women undergoing planned CD for reasons unrelated to this study and who are qualified based on the Instructions for Use (IFU) and who consent to participation.
|
|---|---|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Device was placed but not secured during patient transfer. Device dislodged and subject had to exit.
|
1
|
Baseline Characteristics
Overall, 10 subjects were enrolled and device insertion was attempted. Device insertion was successful in 9 subjects with one subject unable to have the device placed due to a cerclage. Of the 9 subjects, 1 had the device dislodge upon transfer to the gurney. Therefore, only 8 subjects could be fully evaluated.
Baseline characteristics by cohort
| Measure |
Single Arm CD Participants
n=10 Participants
Participants in this single arm study of device use consist of women undergoing planned CD for reasons unrelated to this study and who are qualified based on the Instructions for Use (IFU) and who consent to participation.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants • Overall, 10 subjects were enrolled and device insertion was attempted. Device insertion was successful in 9 subjects with one subject unable to have the device placed due to a cerclage. Of the 9 subjects, 1 had the device dislodge upon transfer to the gurney. Therefore, only 8 subjects could be fully evaluated.
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants • Overall, 10 subjects were enrolled and device insertion was attempted. Device insertion was successful in 9 subjects with one subject unable to have the device placed due to a cerclage. Of the 9 subjects, 1 had the device dislodge upon transfer to the gurney. Therefore, only 8 subjects could be fully evaluated.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants • Overall, 10 subjects were enrolled and device insertion was attempted. Device insertion was successful in 9 subjects with one subject unable to have the device placed due to a cerclage. Of the 9 subjects, 1 had the device dislodge upon transfer to the gurney. Therefore, only 8 subjects could be fully evaluated.
|
|
Sex/Gender, Customized
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Day of surgery (preoperative) and one day post procedurePopulation: Two subjects could not be analyzed for the outcome measure. One subject had a cerclage and could not receive the device. One subject had the device placed but it did not stay in during transfer.
This is a prospective, single-arm, device evaluation study of device use by five (5) obstetrical surgeons placing the drain with low-level suction in up to ten (10) women undergoing elective, non-emergent cesarean delivery. Hemoglobin was measured at two time points: baseline (preoperative) and 1 day post operative. The mean change in hemoglobin concentration between baseline (preoperative) values obtained on the day of surgery and postoperative day 1 was analyzed and compared to historical means in the US in 31 hospitals with 5470 participants.
Outcome measures
| Measure |
Interventional
n=8 Participants
Ten women in whom the Daisy Drain is placed.
|
|---|---|
|
Device Evaluation
|
1.36 g/dL
Standard Deviation 0.47
|
Adverse Events
Interventional
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Tetsuya Kawakita, MD
Eastern Virginia Medical School at Old Dominion University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place