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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Care Group | Active Comparator | "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. |
|
| Protocol Group | Active Comparator | "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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin Infusion | Drug | 500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 15 min from time of infant delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 15 min from time of infant delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence C Tsen, MD | Brigham and Women's Hospital/Harvard Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | IU | Up to 15 min from time of infant delivery |
|
Preoperatively until 6 hrs following cesarean delivery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Tsen, MD | Brigham and Women's Hospital | 617-732-8216 | ltsen@partners.org |
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| ID | Term |
|---|---|
| D014593 | Uterine Inertia |
| D007022 | Hypotension |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D004420 | Dystocia |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D008755 | Methylergonovine |
| C062843 | carboprost tromethamine |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D004874 | Ergonovine |
| D004873 | Ergolines |
| D004876 | Ergot Alkaloids |
| D000470 | Alkaloids |
| D006571 |
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| Oxytocin Bolus | Drug | 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). |
|
|
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | 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). |
|
|
| 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. | All side effects: hypotension, flushing, nausea and emesis | Posted | Count of Participants | Participants | Up to 15 min from time of infant delivery |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | 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). | 0 | 30 | 0 | 30 | 0 | 30 |
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| D000091642 | Urogenital Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Heterocyclic Compounds |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |