Abortion
Conditions
Brief summary
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.
Interventions
DRUGDigoxin
Trans-abdominal injection
DRUGPlacebo
Trans-abdominal injection
Sponsors
FPA Women's Health
Society of Family Planning
Oregon Health and Science University
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 20 weeks 0 days-24 weeks 0 days gestation * English or Spanish speaking * 18 years or older
Exclusion criteria
* Under 18 * Contraindications to digoxin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Duration | Beginning to end of procedure (between 5 minutes and 1 hour) | First instrument into uterus until procedure complete |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Procedure Duration | done on Day 2 during the procedure | Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything |
| Measured Blood Loss | Day 2, during the procedure | measured blood loss, in mL, during the procedure, measured by weighing the absorbent materials used and subtracting out their weight without blood |
| Number of Patients With Reported Fetal Death Prior to Procedure | Day 2, before procedure | number of patients who had fetal death measured by ultrasound |
| Complications | Day 2 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Digoxin Subjects assigned to the intervention arm will receive a 1 mg intrafetal digoxin injection under ultrasound guidance
Digoxin: Trans-abdominal injection | 88 |
| Placebo Subjects assigned to the control arm will receive an ultrasound-guided intrafetal saline injection of the equivalent volume
Placebo: Trans-abdominal injection | 90 |
| Total | 178 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
| Overall Study | Protocol Violation | 1 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | Digoxin |
|---|---|---|---|
| Age, Continuous | 26.2 years STANDARD_DEVIATION 5.6 | 26.8 years STANDARD_DEVIATION 6.2 | 27.3 years STANDARD_DEVIATION 6.7 |
| Body mass index (BMI) | 26.7 kg/m2 STANDARD_DEVIATION 5.2 | 26.9 kg/m2 STANDARD_DEVIATION 5.4 | 27.2 kg/m2 STANDARD_DEVIATION 5.6 |
| Gestational duration | 21.0 weeks | 21.0 weeks | 21.1 weeks |
| Nulliparous | 15 Participants | 36 Participants | 21 Participants |
| Race/Ethnicity, Customized African-American, non-Hispanic | 17 Participants | 34 Participants | 17 Participants |
| Race/Ethnicity, Customized Caucasian, non-Hispanic | 30 Participants | 56 Participants | 26 Participants |
| Race/Ethnicity, Customized Hispanic | 31 Participants | 59 Participants | 28 Participants |
| Race/Ethnicity, Customized Mixed/Multi | 8 Participants | 16 Participants | 8 Participants |
| Race/Ethnicity, Customized Other | 4 Participants | 13 Participants | 9 Participants |
| Sex: Female, Male Female | 90 Participants | 178 Participants | 88 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 0 / 89 |
| other Total, other adverse events | 7 / 86 | 3 / 89 |
| serious Total, serious adverse events | 0 / 86 | 1 / 89 |
Outcome results
Primary
Procedure Duration
First instrument into uterus until procedure complete
Time frame: Beginning to end of procedure (between 5 minutes and 1 hour)
Population: Duration of procedure time from speculum insertion to procedure completion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digoxin | Procedure Duration | 6.8 minutes | Standard Deviation 4.8 |
| Placebo | Procedure Duration | 7.2 minutes | Standard Deviation 6.9 |
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
Time frame: Day 2
Population: any complication reported by patient; may have reported more than one complication
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Digoxin | Complications | 8 Participants |
| Placebo | Complications | 4 Participants |
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
Time frame: Day 2, during the procedure
Population: 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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Digoxin | Measured Blood Loss | 417 mL |
| Placebo | Measured Blood Loss | 363 mL |
Secondary
Number of Patients With Reported Fetal Death Prior to Procedure
number of patients who had fetal death measured by ultrasound
Time frame: Day 2, before procedure
Population: number of patients who had reported fetal death on day 2
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Digoxin | Number of Patients With Reported Fetal Death Prior to Procedure | 68 Participants |
| Placebo | Number of Patients With Reported Fetal Death Prior to Procedure | 6 Participants |
Secondary
Total Procedure Duration
Time from speculum placed until all instruments removed from vagina (including speculum and fingers) and done with everything
Time frame: done on Day 2 during the procedure
Population: 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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Digoxin | Total Procedure Duration | 9.7 minutes | Standard Deviation 9.3 |
| Placebo | Total Procedure Duration | 8.3 minutes | Standard Deviation 7.9 |