Hypotension, Uterine Atony
Conditions
Keywords
Uterine Atony, Hypotension, Cesarean Delivery, Hemorrhage, Phenylephrine, Ephedrine
Brief summary
The central objective of this study will be to evaluate a standardized, evidence-based regimen versus a conventional regimen for uterotonic drug dosing for elective cesarean delivery The investigators primary hypothesis is that the proposed uterotonic drug regimen, when compared to conventional dosing regimen, during elective cesarean delivery will: 1\. Reduce the overall amount of oxytocin and other uterotonic agents used to obtain satisfactory uterine tone. Secondary outcomes to be evaluated will be: 1. Reduce the side effects associated with uterotonic drug use 2. Reduce the time to establishment and maintenance of adequate uterine tone
Detailed description
The current guidelines for the administration of oxytocin during cesarean delivery are diverse, empiric, and vague. A stepwise, standardized, checklist driven algorithm for the use of oxytocin and other uterotonic agents during cesarean delivery is needed to guide practitioners in a clear and concise manner. This algorithm should encompass laboring and non-laboring women, as well as prophylactic and therapeutic uses of oxytocin and other uterotonic agents. More specifically, the investigators believe that the following points should be incorporated into a protocol: 1) oxytocin should be used in initial doses of less than 5 IU; 2) oxytocin should not be administered as a rapid IV bolus; 3) an initial rapid infusion of oxytocin should be followed by a maintenance infusion; 4) higher initial and infusion doses of oxytocin offer no clinical benefit and should be avoided; and 5) if it appears that oxytocin is not producing effective uterine contractions, other uterotonic drugs acting via different pathways should be considered in a standardized way.
Interventions
500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
DRUGOxytocin Bolus
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).
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists (ASA) I or II health status * Age between 18 and 50 yrs * Singleton pregnancies in vertex position * Elective (without prior labor) cesarean delivery with a planned lower uterine (pfannenstiel) incision
Exclusion criteria
* Conditions that predispose to uterine atony and postpartum hemorrhage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone. | Up to 15 min from time of infant delivery | Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use | Up to 15 min from time of infant delivery | Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 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. | 30 |
| 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.
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). | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Standard Care Group | Total | Protocol Group |
|---|---|---|---|
| Age, Customized Between 18 and 40 years of age | 30 Participants | 60 Participants | 30 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 42 Participants | 22 Participants |
| Region of Enrollment United States | 30 participants | 60 participants | 30 participants |
| Sex: Female, Male Female | 30 Participants | 60 Participants | 30 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone.
Will measure total amount of oxytocin to achieve satisfactory uterine tone, as determined by the operating obstetrician.
Time frame: Up to 15 min from time of infant delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Care Group | 1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone. | 8.4 IU | Standard Deviation 4.8 |
| Protocol Group | 1. Amount of Oxytocin to Obtain Satisfactory Uterine Tone. | 4.0 IU | Standard Deviation 0.9 |
Secondary
Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use
Number of subjects experiencing hypotension, flushing, nausea, and emesis reported after administration of uterotonic agents.
Time frame: Up to 15 min from time of infant delivery
Population: All side effects: hypotension, flushing, nausea and emesis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Care Group | Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use | 3 Participants |
| Protocol Group | Side Effects (Hypotension, Flushing, Nausea and Emesis) Associated With Uterotonic Drug Use | 2 Participants |