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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Anti-Arrhythmia Agents
Cardiotonic Agents
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014