Clinical trial NCT01047748: A Trial of Digoxin Before Second-Trimester Abortion
Official title: A Randomized Clinical Trial of Intra-fetal Versus Intra-amniotic Digoxin Prior to Second-Trimester Pregnancy Termination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Induced Abortion
Keywords: abortion
Lead sponsor: White, Katharine O'Connell, M.D., M.P.H.
Sponsor class: INDIV
Collaborators: name: Society of Family Planning
First posted: 2010-01-13
Enrollment: 272
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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

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 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

Primary outcomes:
measure: difference in fetal asystole rates between groups
timeFrame: one day
Secondary outcomes:
measure: digoxin-related side effects
timeFrame: one day
measure: differences in surgical procedure between groups
timeFrame: one day
measure: subject satisfaction
timeFrame: one day
measure: serum digoxin levels in study subgroup
timeFrame: one day
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Planned Parenthood Los Angeles - Bixby Health Center
state: California
Study officials:
affiliation: Physicians for Reproductive Choice and Health
name: Katharine O White, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/s0029-7844(00)01148-0.
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.
citation: 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.
citation: 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.