Trial Outcomes & Findings for Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery. (NCT NCT01932060)
NCT ID: NCT01932060
Last Updated: 2017-02-01
Results Overview
Blood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
51 participants
Primary outcome timeframe
immediately at end of surgery
Results posted on
2017-02-01
Participant Flow
Participant milestones
| Measure |
Oxytocin Infusion 1
Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
|
Oxytocin Infusion 2
Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
|
|---|---|---|
|
Overall Study
STARTED
|
27
|
24
|
|
Overall Study
COMPLETED
|
27
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin Infusions and Blood Loss in Patients Undergoing Elective Cesarean Delivery.
Baseline characteristics by cohort
| Measure |
Oxytocin Infusion 1
n=27 Participants
Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
|
Oxytocin Infusion 2
n=24 Participants
Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34 years
STANDARD_DEVIATION 6 • n=5 Participants
|
32 years
STANDARD_DEVIATION 5 • n=7 Participants
|
33 years
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Gender
Female
|
27 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Gender
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
27 participants
n=5 Participants
|
24 participants
n=7 Participants
|
51 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: immediately at end of surgeryBlood loss will be measured volumetrically (based on measured volume of blood within the suction chamber) and gravimetrically (based on blood weight on blood soaked laps).
Outcome measures
| Measure |
Oxytocin Infusion 1
n=27 Participants
Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
|
Oxytocin Infusion 2
n=24 Participants
Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
|
|---|---|---|
|
Total Estimated Blood Loss
|
512 ml
Interval 405.0 to 740.0
|
634 ml
Interval 340.0 to 886.0
|
SECONDARY outcome
Timeframe: 24 hr after cesarean deliveryStudy investigators will assess maternal hemoglobin levels at 24hr after cesarean delivery
Outcome measures
| Measure |
Oxytocin Infusion 1
n=27 Participants
Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
|
Oxytocin Infusion 2
n=24 Participants
Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.
Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
|
|---|---|---|
|
Hemoglobin Indices After Cesarean Delivery
|
11. g/dl
Interval 9.9 to 11.8
|
11.2 g/dl
Interval 10.3 to 12.2
|
Adverse Events
Oxytocin Infusion 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oxytocin Infusion 2
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
Dr. Alexander Butwick
Stanford University School of Medicine
Phone: (650) 736-8513
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place