Abortion, Induced
Conditions
Brief summary
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).
Interventions
DRUGDigoxin (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.
DRUGDigoxin (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.
Sponsors
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age greater than or equal to 18 years * Singleton viable gestation * Identifying as primarily English-speaking * Body mass index less than 40 kilograms/meters squared * Already a consented patient for second-trimester abortion procedure with digoxin to be performed for termination of pregnancy at the study site * No medical contraindication to digoxin (i.e., no cardiac dysfunction, no renal dysfunction, no hypersensitivity to digoxin)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Discomfort With Digoxin Injection (Pain Score) | At time of study (immediate) | Pain score (indicated by patient reporting pain level from 0 (no hurt) to 5 (hurts worst) at time of digoxin injection) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Transvaginal Digoxin | Transabdominal Digoxin | Total |
|---|---|---|---|
| Age, Continuous | 26.8 Years STANDARD_DEVIATION 6.7 | 26.6 Years STANDARD_DEVIATION 6.1 | 26.7 Years STANDARD_DEVIATION 6.4 |
| Body Mass Index | 27.4 Kilograms/meters squared STANDARD_DEVIATION 5 | 26.7 Kilograms/meters squared STANDARD_DEVIATION 4.8 | 27.1 Kilograms/meters squared STANDARD_DEVIATION 4.8 |
| Gender Female | 30 Participants | 30 Participants | 60 Participants |
| Gender Male | 0 Participants | 0 Participants | 0 Participants |
| Gestational Age | 21.5 Weeks STANDARD_DEVIATION 1.2 | 21.4 Weeks STANDARD_DEVIATION 1.6 | 21.4 Weeks STANDARD_DEVIATION 1.4 |
| Parity | 0.8 Births STANDARD_DEVIATION 0.8 | 0.87 Births STANDARD_DEVIATION 1.2 | 0.83 Births STANDARD_DEVIATION 1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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)
Time frame: At time of study (immediate)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Transvaginal Digoxin | Patient Discomfort With Digoxin Injection (Pain Score) | 2.21 Units on a scale | Standard Deviation 1.33 |
| Transabdominal Digoxin | Patient Discomfort With Digoxin Injection (Pain Score) | 1.88 Units on a scale | Standard Deviation 1.54 |
Comparison: No power calculation performed given that this was a pilot study. The null hypothesis was that there would be no difference in pain score with injection between the two study arms. The Wilcoxon rank sum test was selected because of the study's small sample size and the non-normal distribution of pain scores. Intention to treat analyses were used.p-value: 0.36Wilcoxon (Mann-Whitney)