Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion

NCT ID: NCT02277249

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2014-10-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Transvaginal digoxin

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

Group Type: OTHER

Digoxin (transvaginal administration)

Intervention Type: 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.

Transabdominal digoxin

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

Group Type: OTHER

Digoxin (transabdominal administration)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

IRB#12-001241

Identifier Type: -

Identifier Source: org_study_id