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A phase I, open-label trial to determine a safe dose of oral misoprostol required to augment labor in nulliparous women diagnosed with arrest of dilation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Misoprostol 1 | Experimental | Oral misoprostol 25 micrograms every 4 hours for up to two doses. |
|
| Oral Misoprostol 2 | Experimental | Oral misoprostol 50 micrograms every 4 hours for up to two doses. |
|
| Oral Misoprostol 3 | Experimental | Oral misoprostol 100 micrograms every 4 hours for up to two doses. |
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| Oral Misoprostol 4 | Experimental | Oral Misoprostol 50 micrograms every 2 hours for up to two doses. |
|
| Oral Misoprostol 5 | Experimental | Oral Misoprostol 75 micrograms every 4 hours for up to two doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Misoprostol | Drug | Oral misoprostol |
|
| Measure | Description | Time Frame |
|---|---|---|
| uterine hyperstimulation |
| Measure | Description | Time Frame |
|---|---|---|
| adequate uterine activity | ||
| need for oxytocin augmentation | ||
| time from administration of study drug to delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn S Villano, M.D. | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Term |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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|
| route of delivery and indications |
| maternal and neonatal infectious morbidity |
| neonatal outcomes |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |