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The purpose of this study is to assess the effectiveness of prophylactic oxytocin on hemorrhage rates for second trimester dilation and evacuation (D&E) in the clinic setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxytocin | Experimental | Participants receive 40 units IV oxytocin in 1000 mL of normal saline at the time of tenaculum placement for D&E. |
|
| Placebo | Placebo Comparator | Participants receive 1000 mL of normal saline alone at the time of tenaculum placement for D&E. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxytocin + normal saline | Drug | 40 units IV oxytocin once in a 1000 mL bag of normal saline |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Hemorrhage | Quantitative blood loss greater than or equal to 500 mL or a clinical response to excessive bleeding such as transfusion or hospital admission | day of procedure |
| Quantitative blood loss | Measured blood loss during procedure | day of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure time | Length of time of total procedure and length of time until bleeding initially managed | day of procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction and pain scores | Patient satisfaction with procedure and maximum reported pain on a visual analog scale | day of procedure |
| Ease of procedure | Provider reported ease of procedure |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megan Masten, MD | Contact | 303-724-8576 | megan.masten@cuanschutz.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Women's Health Center | Recruiting | Denver | Colorado | 80230 | United States |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010121 | Oxytocin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010909 | Pituitary Hormones, Posterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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Randomized controlled trial - randomized to either receive treatment (40 units IV oxytocin + 1000 mL normal saline) or placebo (1000 mL normal saline alone).
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This will be a double blinded study.
| Normal saline |
| Drug |
1000 mL bag of normal saline alone |
|
| day of procedure |
| Rate of additional uterotonics | Report of additional medications to treat bleeding used | day of procedure |
| Cost of additional uterotonics | Estimated cost of additional uterotonics used | day of procedure |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |