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| ID | Type | Description | Link |
|---|---|---|---|
| 5K12HD001258-09 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This is a double-blind 3-arm randomized clinical trial to determine whether higher dose oxytocin regimens (compared to the standard regimen) reduce the frequency of uterine atony and postpartum hemorrhage after vaginal delivery. Uterine atony is a loss of tone in the uterine musculature which can cause acute postpartum hemorrhage, which is the major cause of maternal mortality worldwide. Oxytocin is routinely administered postpartum in the US and effectively reduces uterine atony. The optimal dose of oxytocin for vaginal delivery is not known.
Same as brief summary. Prospective interim monitoring (stopping) rules will be assessed upon recruitment of 2/3rds of the sample size of 1800. Interim review was conducted by a 3-member DSMB in January of 2010 and their recommendations were implemented.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin 10 units/500cc | Active Comparator | 1 dose only for prophylaxis given over 1 hour |
|
| Oxytocin 40 units/500cc | Experimental | One dose only given over 1 hour. Per DSMB recommendations, this intermediate arm was stopped Jan 2010. |
|
| Oxytocin 80U/500cc | Experimental | 1 dose only given over 1 hour |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin | Drug | See arms |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment | the number of subjects with any treatment of uterineatony or hemorrhage. | baseline to discharge (2 - 3 days) |
| Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage | In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus. | Initial hospital discharge (2-3 days) |
| Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors | The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia. | baseline to discharge (2-3 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pre- to Post-delivery Hematocrit (%) | change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery) | During delivery hospitalization: Admission hematocrit - post-delivery hematocrit |
| Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan T Tita, MD, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22227638 | Result | Tita AT, Szychowski JM, Rouse DJ, Bean CM, Chapman V, Nothern A, Figueroa D, Quinn R, Andrews WW, Hauth JC. Higher-dose oxytocin and hemorrhage after vaginal delivery: a randomized controlled trial. Obstet Gynecol. 2012 Feb;119(2 Pt 1):293-300. doi: 10.1097/AOG.0b013e318242da74. |
| Label | URL |
|---|---|
| PUBMED Abstract of Results | View source |
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At planned interim review (n=1,201), enrollment in the 40-unit group was stopped for futility and enrollment continued in the other groups.
There were 1,798 women randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oxytocin 10 Units/500cc | |
| FG001 | Oxytocin 40 Units/500cc | Per DSMB recommendations, this intermediate arm was stopped Jan 2010. |
| FG002 | Oxytocin 80U/500cc |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oxytocin 10 Units/500cc | |
| BG001 | Oxytocin 40 Units/500cc | Per DSMB recommendations, this intermediate arm was stopped Jan 2010. |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Subjects Reporting Uterine Atony or Postpartum Hemorrhage Requiring Medical (Medication or Blood Transfusion), Surgical or Other Interventional Treatment | the number of subjects with any treatment of uterineatony or hemorrhage. | Posted | Number | Participants | baseline to discharge (2 - 3 days) |
|
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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 | Oxytocin 10 Units/500cc |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alan T. N. Tita, MD | University of Alabama at Birmingham | (205) 934-9616 | atit@uab.edu |
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| ID | Term |
|---|---|
| D014593 | Uterine Inertia |
| D006473 | Postpartum 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 |
|---|---|
| D010121 | Oxytocin |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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the number of individuals with each of the component treatments or individual outcomes in the primary composite. |
| prior to discharge |
| Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc) | the number of individuals with a clinically estimated postpartum blood loss of 500cc or more | Initial hospital discharge (2-3 days) |
| Number of Subjects With Hospital Stays Greater Than 4 Days | Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge | Initial hospital discharge (2 days or more) |
| Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus | number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure) | Initial hospital discharge (2-3 days or more) |
| Oxytocin 80U/500cc |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Oxytocin 80U/500cc |
1 dose only for prophylaxsis given over 1 hour |
|
|
| Primary | Women in Each Group With Risk Factors for Atony or Postpartum Hemorrhage | In a secondary data analysis, a parsimonious set of independent risk factors for atony or postpartum hemorrhage was established: White, Hispanic, or Other (non-Black of African American) race/ethnicity, preeclampsia, or chorioamnionitus. | Posted | Number | participants | Initial hospital discharge (2-3 days) |
|
|
|
| Secondary | Change in Pre- to Post-delivery Hematocrit (%) | change in hematocrit from admission for delivery (baseline) to post-delivery (4 hours-1day postpartum depending on time of delivery) | Posted | Median | Inter-Quartile Range | hematocrit difference (%) | During delivery hospitalization: Admission hematocrit - post-delivery hematocrit |
|
|
|
| Secondary | Number of Participants Experiencing Individual Treatment or Intervention in the Primary Outcome | the number of individuals with each of the component treatments or individual outcomes in the primary composite. | Posted | Number | Participants | prior to discharge |
|
|
|
| Secondary | Number of Participants Experiencing Postpartum Hemorrhage (Clinical Estimate Greater Than 500cc) | the number of individuals with a clinically estimated postpartum blood loss of 500cc or more | Posted | Number | Participants | Initial hospital discharge (2-3 days) |
|
|
|
| Secondary | Number of Subjects With Hospital Stays Greater Than 4 Days | Number of individuals with prolonged hospitalization defined as 4 days or more prior to initial hospital discharge | Posted | Number | Participants | Initial hospital discharge (2 days or more) |
|
|
|
| Secondary | Number of Subjects Requiring Hypotension Warranting Pressor Agent or Fluid Bolus | number of individuals with hypotension leading to administration of a fluid bolus or vasopressor agent (medication given to raise the blood pressure) | Posted | Number | Participants | Initial hospital discharge (2-3 days or more) |
|
|
|
| Primary | Risk to Using Increasing Doses of Oxytocin Based on Pre-specified Risk Factors | The frequency of the primary study outcome is examined in a subgroup of 939 women with risk factors for atony or postpartum hemorrhage. These risk factors are identified as White, Hispanic, or Other (non-Black or African American) race/ethnicity, chorioamnionitis, and preeclampsia. | Posted | Number | participants | baseline to discharge (2-3 days) |
|
|
|
|
| 0 |
| 659 |
| 0 |
| 659 |
| EG001 | Oxytocin 40 Units/500cc | Per DSMB recommendations, this intermediate arm was stopped Jan 2010. | 0 | 481 | 0 | 481 |
| EG002 | Oxytocin 80U/500cc | 0 | 658 | 0 | 658 |
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| D000091642 | Urogenital Diseases |
| D011644 | Puerperal Disorders |
| D014592 | Uterine Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| Title | Measurements |
|---|---|
|
| Surgical |
|
| Other-Tamponade |
|
| Other-Arterial embolization |
|
|