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| Name | Class |
|---|---|
| FPA Women's Health | UNKNOWN |
| Society of Family Planning | OTHER |
| Oregon Health and Science University | OTHER |
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This is a research study to measure the effect of digoxin injection on Dilation and Evacuation (D&E) procedure duration. Digoxin is the most commonly used feticidal agent among family planning subspecialists, and is commonly used for a variety of reasons including provider preference, patient preference, and concerns over legal status of later D&E procedures. There have been several studies on digoxin administration, adverse effects, and impact on the D&E procedure, but doctors want to clarify how digoxin effects D&E procedure time, if at all.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digoxin | Experimental | Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance |
|
| Placebo | Placebo Comparator | Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digoxin | Drug | Trans-abdominal injection |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Duration | First instrument into uterus until procedure complete | Beginning to end of procedure (between 5 minutes and 1 hour) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Procedure Duration | Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything | done on Day 2 during the procedure |
| Measured Blood Loss |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| FPA Women's Health | Long Beach | California | 90806 | United States | ||
| SFGH Women's Options Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Digoxin | Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection |
| FG001 | Placebo | Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Digoxin | Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection |
| BG001 | Placebo |
| 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 | Procedure Duration | First instrument into uterus until procedure complete | Duration of procedure time from speculum insertion to procedure completion | Posted | Mean | Standard Deviation | minutes | Beginning to end of procedure (between 5 minutes and 1 hour) |
|
two days, day one and day two
does not differ from clinicaltrials.gov
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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 | Digoxin | Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance Digoxin: Trans-abdominal injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| blood transfusion | Blood and lymphatic system disorders | Non-systematic Assessment | Post-D&E hemorrhage, patient admitted for transfusion |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| pregnancy labor | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | patient went into labor prior to D&E (Dilation and evacuation), had D&C (Dilation and curettage) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | UCSF | 414-206-8715 | abby.sokoloff@ucsf.edu |
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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 | Dec 13, 2017 | Oct 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D004077 | Digoxin |
| ID | Term |
|---|---|
| D004071 | Digitalis Glycosides |
| D002298 | Cardenolides |
| D002301 | Cardiac Glycosides |
| D002297 | Cardanolides |
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| Drug |
Trans-abdominal injection |
|
measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood
| Day 2, during the procedure |
| Number of Patients With Reported Fetal Death Prior to Procedure | number of patients who had fetal death measured by ultrasound | Day 2, before procedure |
| Complications | hemorrhage, perforation, cervical laceration requiring suture repair, out-of-hospital delivery, infection, inability to complete injection, other complications of the injection itself, and patient symptoms such as nausea and vomiting | Day 2 |
| San Francisco |
| California |
| 94110 |
| United States |
| Lovejoy Surgicenter | Portland | Oregon | 97210 | United States |
Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume
Placebo: Trans-abdominal injection
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m2 |
|
| Nulliparous | Count of Participants | Participants |
|
| Gestational duration | Median | Inter-Quartile Range | weeks |
|
|
|
| Secondary | Total Procedure Duration | Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything | duration of procedure for each participant from insertion of speculum to total procedure completion, including any post-procedure activities prior to being taken to recovery | Posted | Mean | Standard Deviation | minutes | done on Day 2 during the procedure |
|
|
|
| Secondary | Measured Blood Loss | measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood | measured blood loss was only completed at the Zuckerberg San Francisco General Hospital location, which is why the total is 61 rather than 175 for this outcome | Posted | Median | Inter-Quartile Range | mL | Day 2, during the procedure |
|
|
|
| Secondary | Number of Patients With Reported Fetal Death Prior to Procedure | number of patients who had fetal death measured by ultrasound | number of patients who had reported fetal death on day 2 | Posted | Count of Participants | Participants | Day 2, before procedure |
|
|
|
| Secondary | Complications | hemorrhage, perforation, cervical laceration requiring suture repair, out-of-hospital delivery, infection, inability to complete injection, other complications of the injection itself, and patient symptoms such as nausea and vomiting | any complication reported by patient; may have reported more than one complication | Posted | Count of Participants | Participants | Day 2 |
|
|
|
| 0 |
| 86 |
| 0 |
| 86 |
| 7 |
| 86 |
| EG001 | Placebo | Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume Placebo: Trans-abdominal injection | 0 | 89 | 1 | 89 | 3 | 89 |
|
|
| severe nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| hemmorhage | Blood and lymphatic system disorders | Non-systematic Assessment | 1 post-D&E hemorrhage (requiring vag pack and med tx) 1 intra-op hemorrhage requiring Foley and med tx |
|
| anxiety | Nervous system disorders | Non-systematic Assessment | severe anxiety/pain post D&E requiring medications |
|
| cramping | Reproductive system and breast disorders | Non-systematic Assessment | extreme cramping pain following injection severe cramping pain post D&E requiring medications |
|
| fever | General disorders | Non-systematic Assessment |
|
| mass | Reproductive system and breast disorders | Non-systematic Assessment | MD identified uterine mass, pt transferred to hospital |
|
| vomiting | Gastrointestinal disorders | Non-systematic Assessment | extreme nausea/vomiting following injection |
|
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| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006027 | Glycosides |
| D002241 | Carbohydrates |