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

January 11, 2010
April 29, 2013
January 2011
January 2013   (final data collection date for primary outcome measure)
difference in fetal asystole rates between groups [ Time Frame: one day ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01047748 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Trial of Digoxin Before Second-Trimester Abortion
A Randomized Clinical Trial of Intra-fetal Versus Intra-amniotic Digoxin Prior to Second-Trimester Pregnancy Termination

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

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Induced Abortion
  • Drug: intra-fetal digoxin injection
    Single transabdominal injection of digoxin 1 mg into the fetus
    Other Name: Lanoxin
  • Drug: intra-amniotic digoxin injection
    Single transabdominal injection of digoxin 1 mg into the amniotic fluid
    Other Name: Lanoxin
  • Active Comparator: intra-fetal injection
    Subjects will receive an intra-fetal digoxin injection one day prior to their second-trimester surgical abortion
    Intervention: Drug: intra-fetal digoxin injection
  • Active Comparator: intra-amniotic injection
    Subjects will receive an intra-amniotic digoxin injection one day prior to their second-trimester surgical abortion
    Intervention: Drug: intra-amniotic digoxin injection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
272
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01047748
20082058
No
White, Katharine O'Connell, M.D., M.P.H.
White, Katharine O'Connell, M.D., M.P.H.
Society of Family Planning
Principal Investigator: Katharine O White, MD, MPH Physicians for Reproductive Choice and Health
White, Katharine O'Connell, M.D., M.P.H.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP