A Trial of Digoxin Before Second-Trimester Abortion

Induced Abortion Clinical Trial

Official title:

A Randomized Clinical Trial of Intra-fetal Versus Intra-amniotic Digoxin Prior to Second-Trimester Pregnancy Termination

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047748
• Other study ID #: 20082058
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: April 29, 2013
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: White, Katharine O'Connell, M.D., M.P.H.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Induced Abortion

Intervention

Drug:
• intra-fetal digoxin injection
Single transabdominal injection of digoxin 1 mg into the fetus
• intra-amniotic digoxin injection
Single transabdominal injection of digoxin 1 mg into the amniotic fluid

Locations

Country	Name	City	State
United States	Planned Parenthood Los Angeles - Bixby Health Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
White, Katharine O'Connell, M.D., M.P.H.	Society of Family Planning

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in fetal asystole rates between groups		one day	No
Secondary	digoxin-related side effects		one day	Yes
Secondary	differences in surgical procedure between groups		one day	No
Secondary	subject satisfaction		one day	No
Secondary	serum digoxin levels in study subgroup		one day	No