Transvaginal Versus Transabdominal Digoxin Prior to Second-trimester Abortion

Overview

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).

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2014

Interventions

  • 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.
  • 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.

Arms, Groups and Cohorts

  • Other: Transvaginal digoxin
    • Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion
  • Other: Transabdominal digoxin
    • Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion

Clinical Trial Outcome Measures

Primary Measures

  • Patient Discomfort With Digoxin Injection (Pain Score)
    • Time Frame: 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)

Participating in This Clinical Trial

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)

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of California, Los Angeles
  • Provider of Information About this Clinical Study
    • Sponsor

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