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.

Study Overview

• Status: Completed
• Conditions: Induced Abortion
• Intervention / Treatment: Drug: intra-fetal digoxin injection; Drug: intra-amniotic digoxin injection

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.

• Study Type: Interventional
• Enrollment (Actual): 272
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Planned Parenthood Los Angeles - Bixby Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: Lanoxin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
difference in fetal asystole rates between groups	one day

Secondary Outcome Measures

Outcome Measure	Time Frame
digoxin-related side effects	one day
differences in surgical procedure between groups	one day
subject satisfaction	one day
serum digoxin levels in study subgroup	one day

Collaborators and Investigators

• Sponsor: White, Katharine O'Connell, M.D., M.P.H.
• Collaborators: Society of Family Planning
• Investigators: Principal Investigator: Katharine O White, MD, MPH, Physicians for Reproductive Choice and Health

Publications and helpful links

General Publications

• Jackson RA, Teplin VL, Drey EA, Thomas LJ, Darney PD. Digoxin to facilitate late second-trimester abortion: a randomized, masked, placebo-controlled trial. Obstet Gynecol. 2001 Mar;97(3):471-6. doi: 10.1016/s0029-7844(00)01148-0.
• Molaei M, Jones HE, Weiselberg T, McManama M, Bassell J, Westhoff CL. Effectiveness and safety of digoxin to induce fetal demise prior to second-trimester abortion. Contraception. 2008 Mar;77(3):223-5. doi: 10.1016/j.contraception.2007.10.011. Epub 2008 Jan 22.
• Drey EA, Thomas LJ, Benowitz NL, Goldschlager N, Darney PD. Safety of intra-amniotic digoxin administration before late second-trimester abortion by dilation and evacuation. Am J Obstet Gynecol. 2000 May;182(5):1063-6. doi: 10.1067/mob.2000.105438.
• White KO, Nucatola DL, Westhoff C. Intra-fetal Compared With Intra-amniotic Digoxin Before Dilation and Evacuation: A Randomized Controlled Trial. Obstet Gynecol. 2016 Nov;128(5):1071-1076. doi: 10.1097/AOG.0000000000001671.

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: January 11, 2010
• First Submitted That Met QC Criteria: January 12, 2010
• First Posted (Estimate): January 13, 2010

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: abortion
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Digoxin
• Other Study ID Numbers: 20082058