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| Name | Class |
|---|---|
| Society of Family Planning | OTHER |
| University of Washington | OTHER |
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Currently, there is very little research to identify ways to decrease blood loss during D&E (dilation and evacuation) procedures. The objective is to determine whether routine use of intravenous oxytocin will improve bleeding outcomes at the time of D&E at 18-24-weeks gestation. To evaluate the hypothesis, investigators will perform a randomized, double-blinded, placebo-controlled trial. The patient will be followed until discharged from the postoperative care unit during which time patient satisfaction, pain score and postoperative bleeding will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 500ml saline or lactated ringer without oxytocin added |
|
| Treatment group | Active Comparator | Intravenous oxytocin mixed with saline or lactated ringer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intravenous oxytocin | Drug | 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. | During surgical procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Hawaii | Honolulu | Hawaii | 96826 | United States | ||
| University of Washington |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30741801 | Derived | Whitehouse K, Tschann M, Soon R, Davis J, Micks E, Salcedo J, Savala M, Kaneshiro B. Effects of Prophylactic Oxytocin on Bleeding Outcomes in Women Undergoing Dilation and Evacuation: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):484-491. doi: 10.1097/AOG.0000000000003104. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | 500ml saline or lactated ringer without oxytocin added Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid |
| FG001 | Treatment Group | Intravenous oxytocin mixed with saline or lactated ringer intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | 500ml saline or lactated ringer without oxytocin added Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid |
| BG001 | Treatment Group | Intravenous oxytocin mixed with saline or lactated ringer intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer) |
| 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 | Rate at Which Providers Intervene to Control Blood Loss During D&E Procedures. | Posted | Count of Participants | Participants | During surgical procedure |
|
|
1 day
laceration of the cervix requiring repair with suturing
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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 | Placebo | 500ml saline or lactated ringer without oxytocin added Intravenous Fluids and Electrolytes: 500 ml of inert IV fluid |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| cervical laceration | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. | University of Hawaii | 8082036500 | whrc@ucera.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 26, 2014 | Nov 25, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004108 | Dilatation, Pathologic |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004573 | Electrolytes |
| ID | Term |
|---|---|
| D007287 | Inorganic Chemicals |
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| Intravenous Fluids and Electrolytes | Drug | 500 ml of inert IV fluid |
|
| Seattle |
| Washington |
| 98104 |
| United States |
| BG002 | Total | Total of all reporting groups |
| age |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 78 |
| 1 |
| 78 |
| 0 |
| 78 |
| EG001 | Treatment Group | Intravenous oxytocin mixed with saline or lactated ringer intravenous oxytocin: 30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer) | 0 | 82 | 1 | 82 | 0 | 82 |
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