Trial Outcomes & Findings for Oxytocin And Uterotonic Agent Use For Cesarean Delivery (NCT NCT01549223)
NCT ID: NCT01549223
Last Updated: 2017-06-29
Results Overview
Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
60 participants
Primary outcome timeframe
Up to 15 min from time of infant delivery
Results posted on
2017-06-29
Participant Flow
Participant milestones
| Measure |
Standard Care Group
"Standard Care Group" (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion "oxytocin". If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM (Intramuscular) or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
|
Protocol Group
"Protocol Group" will receive 3 mL syringes marked "study solution-oxytocin" which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked "study solution-9 min", containing methylergonovine maleate (methergine) 0.2mg, will be given IM (Intramuscular).
If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked "study solution-12 min", containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
30
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Oxytocin And Uterotonic Agent Use For Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Standard Care Group
n=30 Participants
"Standard Care Group" (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion "oxytocin". If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
|
Protocol Group
n=30 Participants
"Protocol Group" will receive 3 mL syringes marked "study solution-oxytocin" which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked "study solution-9 min", containing methylergonovine maleate (methergine) 0.2mg, will be given IM.
If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked "study solution-12 min", containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 18 and 40 years of age
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 15 min from time of infant deliveryWill measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.
Outcome measures
| Measure |
Standard Care Group
n=30 Participants
"Standard Care Group" (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion "oxytocin". If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
|
Protocol Group
n=30 Participants
"Protocol Group" will receive 3 mL syringes marked "study solution-oxytocin" which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked "study solution-9 min", containing methylergonovine maleate (methergine) 0.2mg, will be given IM.
If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked "study solution-12 min", containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
|
|---|---|---|
|
1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.
|
8.4 IU
Standard Deviation 4.8
|
4.0 IU
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Up to 15 min from time of infant deliveryPopulation: All side effects: hypotension, flushing, nausea and emesis
Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.
Outcome measures
| Measure |
Standard Care Group
n=30 Participants
"Standard Care Group" (reflects current clinical regimen at BWH) will receive a 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. The obstetrician and anesthesiologist will be asked to consider this infusion "oxytocin". If inadequate uterine tone exists in which the obstetrician desires alternative uterotonic agents, these will be provided on their request (e.g. methylergonovine maleate (methergine) 0.2 mg IM or carboprost tromethamine (hemabate) 0.25 mg IM. The time of the requests will be recorded.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
|
Protocol Group
n=30 Participants
"Protocol Group" will receive 3 mL syringes marked "study solution-oxytocin" which contain 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
If inadequate uterine tone is noted at 9 min, the 1 mL syringe marked marked "study solution-9 min", containing methylergonovine maleate (methergine) 0.2mg, will be given IM.
If inadequate uterine tone is noted at 12 min, the 1 mL syringe marked marked "study solution-12 min", containing carboprost tromethamine (hemabate) 0.25 mg, will be given IM.
If uterine tone remains inadequate at 15 min, misoprostol 600 mcg will be given buccally.
Oxytocin: 3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
|
|---|---|---|
|
Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use
|
3 Participants
|
2 Participants
|
Adverse Events
Standard Care Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Protocol 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