A Trial of Digoxin Before Second-Trimester Abortion

This study has been completed.
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
White, Katharine O'Connell, M.D., M.P.H.
ClinicalTrials.gov Identifier:
NCT01047748
First received: January 11, 2010
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

The purpose of our study is to determine the optimum route for the injection of digoxin prior to second-trimester surgical abortion.


Condition Intervention
Induced Abortion
Drug: intra-fetal digoxin injection
Drug: intra-amniotic digoxin injection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Randomized Clinical Trial of Intra-fetal Versus Intra-amniotic Digoxin Prior to Second-Trimester Pregnancy Termination

Resource links provided by NLM:


Further study details as provided by White, Katharine O'Connell, M.D., M.P.H.:

Primary Outcome Measures:
  • difference in fetal asystole rates between groups [ Time Frame: one day ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • digoxin-related side effects [ Time Frame: one day ] [ Designated as safety issue: Yes ]
  • differences in surgical procedure between groups [ Time Frame: one day ] [ Designated as safety issue: No ]
  • subject satisfaction [ Time Frame: one day ] [ Designated as safety issue: No ]
  • serum digoxin levels in study subgroup [ Time Frame: one day ] [ Designated as safety issue: No ]

Enrollment: 272
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: intra-fetal injection
Subjects will receive an intra-fetal digoxin injection one day prior to their second-trimester surgical abortion
Drug: intra-fetal digoxin injection
Single transabdominal injection of digoxin 1 mg into the fetus
Other Name: Lanoxin
Active Comparator: intra-amniotic injection
Subjects will receive an intra-amniotic digoxin injection one day prior to their second-trimester surgical abortion
Drug: intra-amniotic digoxin injection
Single transabdominal injection of digoxin 1 mg into the amniotic fluid
Other Name: Lanoxin

Detailed Description:

Of the 1.2 million abortions each year in the U.S., approximately 12% take place in the second trimester of pregnancy. The preferred technique for second-trimester pregnancy termination is dilation and evacuation, or D&E. In 2006, 144,000 D&Es were performed in the U.S. Clinicians often achieve preoperative fetal asystole by a maternal transabdominal injection of digoxin. Prior to D&E, providers use digoxin to induce fetal death 1) for providers' preference to facilitate surgical delivery of the fetus, and/or 2) for patients who express a desire for fetal death prior to the abortion.

The use of digoxin to achieve preoperative fetal asystole is widespread, yet there are no evidence-based standards for how to best achieve fetal asystole prior to D&E. Digoxin has been administered by intracardiac, intrathoracic, intrafetal and intra-amniotic routes, with doses varying from 0.25 to 2mg. Clinicians who use digoxin usually inject it one to two days before the D&E. Only one study has assessed the effectiveness of digoxin at varying dosages ; this was a retrospective and nonrandomized analysis. Published failure rates are based on small numbers of patients and are therefore imprecise. Intrafetal digoxin injection may be more effective, but is a technically more difficult procedure than intra-amniotic injection. The pharmacodynamics of digoxin when used for feticide are also unknown. The objective of this study is to determine the optimum route for digoxin injection (intrafetal or intra-amniotic) that will maximize patient safety while maintaining effectiveness.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • at least 18 years old
  • English or Spanish speaking
  • be able to give informed consent
  • documented fetal cardiac activity.

Exclusion Criteria:

  • significant medical illness or cardiovascular disease
  • current use of cardiac or antihypertensive medications
  • cardiac arrhythmia on preoperative EKG
  • multiple gestation
  • morbid obesity (BMI greater than 40)
  • known digoxin allergy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047748

Locations
United States, California
Planned Parenthood Los Angeles - Bixby Health Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
White, Katharine O'Connell, M.D., M.P.H.
Society of Family Planning
Investigators
Principal Investigator: Katharine O White, MD, MPH Physicians for Reproductive Choice and Health
  More Information

Publications:
Responsible Party: White, Katharine O'Connell, M.D., M.P.H.
ClinicalTrials.gov Identifier: NCT01047748     History of Changes
Other Study ID Numbers: 20082058
Study First Received: January 11, 2010
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by White, Katharine O'Connell, M.D., M.P.H.:
abortion

Additional relevant MeSH terms:
Digoxin
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014