Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion

Not Applicable

Completed

• Conditions: Abortion, Induced
• Interventions: Drug: Digoxin (transvaginal administration); Drug: Digoxin (transabdominal administration)

• Registration Number: NCT02277249
• Lead Sponsor: University of California, Los Angeles

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-25
• Study First Posted: 2014-10-28
• Results First Submitted: 2016-02-08
• Results First Submitted QC: 2016-08-25
• Results First Posted: 2016-10-19
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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)

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transvaginal digoxin	Digoxin (transvaginal administration)	Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
Transabdominal digoxin	Digoxin (transabdominal administration)	Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion

Primary Outcome Measures

Name	Time	Method
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)