Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion

NCT02277249 | Completed Results

• 1 other identifier: IRB#12-001241
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Abortion, Induced

Outcome Measures

Primary Outcomes (1)

• 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)

  At time of study (immediate)

Study Arms (2)

Transvaginal digoxin

OTHER

Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion

Drug: Digoxin (transvaginal administration)

Transabdominal digoxin

OTHER

Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion

Drug: Digoxin (transabdominal administration)

Interventions

Digoxin (transvaginal administration) DRUG

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.

Transvaginal digoxin

Digoxin (transabdominal administration) DRUG

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.

Transabdominal digoxin

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead

MeSH Terms

Interventions

Digoxin

Intervention Hierarchy (Ancestors)

Digitalis Glycosides; Cardenolides; Cardiac Glycosides; Cardanolides; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Glycosides; Carbohydrates

Limitations and Caveats

There was crossover between treatment arms (4 subjects in the transvaginal group received transabdominal digoxin). This study is limited by its small sample size and attendant statistical power.

Results Point of Contact

• Title: Clinical Instructor - Department of Obstetrics and Gynecology
• Organization: University of California, Los Angeles

priyabatra@mednet.ucla.edu

3107942257

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2014
• First Posted: October 28, 2014
• Study Start: October 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: January 13, 2017
• Results First Posted: October 19, 2016

Record last verified: 2016-11