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| ID | Type | Description | Link |
|---|---|---|---|
| RRU001 |
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| Name | Class |
|---|---|
| Bill and Melinda Gates Foundation | OTHER |
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This study examines the safety and acceptability of a novel "two dose" regimen of methotrexate to treat ectopic pregnancy.
The regimen is an attempt to create a middle ground between the 2 commonly used regimens - "single dose" and "multi dose". The "multi dose" regimen is more effective, but the "single dose" regimen is more convenient for patients and has fewer side effects.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methotrexate | Drug | Two dose methotrexate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of side effects | Till quantitative bhCG values fall to zero or below 5mIU/mL |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of treatment of ectopic pregnancy (defined as no surgical intervention) | Till quantitative bhCG values fall to zero or below 5mIU/mL |
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Inclusion Criteria:
Confirmed diagnosis of ectopic pregnancy via
the subject is hemodynamically stable without signs of hemoperitoneum
laparoscopy has not been performed
the subject is able to return for frequent follow-up care
normal renal and liver function have been documented within 2 days
normal white blood count and platelet count have been documented as per laboratory standard
normal chest x-ray was obtained if the subject has a history of pulmonary disease
no history of allergy or sensitivity to methotrexate or any component of its formulation
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kurt T Barnhart, MD, MSCE | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California Women's and Children's Hospital | Los Angeles | California | 90033 | United States | ||
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| ID | Term |
|---|---|
| D011271 | Pregnancy, Ectopic |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| University of Miami |
| Miami |
| Florida |
| 33101 |
| United States |
| University of Pennsylvania Reproductive Research Unit | Philadelphia | Pennsylvania | 19104 | United States |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |