N/A
N=60
Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion
Abortion, Induced
Bottom Line
View on ClinicalTrials.gov: NCT02277249 ↗Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Patient Discomfort With Digoxin Injection (Pain Score) — 2.21; 1.88 Units on a scale — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Digoxin (transvaginal administration) (Drug); Digoxin (transabdominal administration) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of California, Los Angeles
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Discomfort With Digoxin Injection (Pain Score) |
2.21; 1.88 | 0.36 |
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).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02277249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.