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Current practice for the provision of late second trimester abortion (dilation and evacuation, or D&E) often involves the administration of digoxin into the fetal compartment to induce fetal demise prior to the procedure. Digoxin may be administered transabdominally or transvaginally into the fetal compartment. Both modes of administration have been shown in prospective studies to be highly effective and safe. Both modes of administration are considered standard of care. This pilot study will directly compare transabdominal and transvaginal digoxin with respect to patient preference (i.e, patient pain score describing discomfort with injection).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvaginal digoxin | Other | Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion |
|
| Transabdominal digoxin | Other | Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin (transvaginal administration) | Drug | Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Discomfort With Digoxin Injection (Pain Score) | Pain score (indicated by patient reporting pain level from 0 ("no hurt") to 5 ("hurts worst") at time of digoxin injection) | At time of study (immediate) |
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Inclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Transvaginal Digoxin | Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied. |
| FG001 | Transabdominal Digoxin | Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Transvaginal Digoxin | Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied. |
| 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 | Patient Discomfort With Digoxin Injection (Pain Score) | Pain score (indicated by patient reporting pain level from 0 ("no hurt") to 5 ("hurts worst") at time of digoxin injection) | Posted | Mean | Standard Deviation | Units on a scale | At time of study (immediate) |
|
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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 | Transvaginal Digoxin | Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied. |
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There was crossover between treatment arms (4 subjects in the transvaginal group received transabdominal digoxin). This study is limited by its small sample size and attendant statistical power.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Instructor - Department of Obstetrics and Gynecology | University of California, Los Angeles | 3107942257 | priyabatra@mednet.ucla.edu |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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|
| Digoxin (transabdominal administration) | Drug | Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied. |
|
| BG001 | Transabdominal Digoxin | Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Gender | Count of Participants | Participants |
|
| Gestational Age | Mean | Standard Deviation | Weeks |
|
| Parity | Mean | Standard Deviation | Births |
|
| Body Mass Index | Mean | Standard Deviation | Kilograms/meters squared |
|
Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion
Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied.
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Transabdominal Digoxin | Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a "Procedure/Surgery" type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied. | 0 | 30 | 0 | 30 |
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |