Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion

Abortion, Induced Clinical Trial

Official title:

Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion: a Pilot Study of Patient Preference

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02277249
• Other study ID #: IRB#12-001241
• Status: Completed
• Phase: N/A
• First received: October 21, 2014
• Last updated: October 25, 2014
• Start date: October 2012
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Abortion, Induced

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient discomfort with digoxin injection (pain score)	The primary outcome (pain score) is measured on the day of procedure (post-digoxin injection). We identify this as "day 0" in the time frame. The primary outcome is not assessed at any additional time points/frames.	Outcome measured once on "day 0" (immediately post-digoxin injection)	No