NCT01047748

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
272

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 13, 2010

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

2 years

First QC Date

January 11, 2010

Last Update Submit

April 29, 2013

Conditions

Induced Abortion

Keywords

abortion

Outcome Measures

Primary Outcomes (1)

  • difference in fetal asystole rates between groups

    one day

Secondary Outcomes (4)

  • 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

Study Arms (2)

intra-fetal injection

ACTIVE COMPARATOR

Subjects will receive an intra-fetal digoxin injection one day prior to their second-trimester surgical abortion

Drug: intra-fetal digoxin injection

intra-amniotic injection

ACTIVE COMPARATOR

Subjects will receive an intra-amniotic digoxin injection one day prior to their second-trimester surgical abortion

Drug: intra-amniotic digoxin injection

Interventions

intra-fetal digoxin injectionDRUG

Single transabdominal injection of digoxin 1 mg into the fetus

Also known as: Lanoxin
intra-fetal injection
intra-amniotic digoxin injectionDRUG

Single transabdominal injection of digoxin 1 mg into the amniotic fluid

Also known as: Lanoxin
intra-amniotic injection

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • at least 18 years old
  • English or Spanish speaking
  • be able to give informed consent
  • documented fetal cardiac activity.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Planned Parenthood Los Angeles - Bixby Health Center

Los Angeles, California, 90033, United States

Location

Related Publications (4)

  • 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.

    PMID: 11239659BACKGROUND

  • 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.

    PMID: 18279695BACKGROUND

  • 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.

    PMID: 10819828BACKGROUND

  • 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.

    PMID: 27741192DERIVED

MeSH Terms

Interventions

Digoxin

Intervention Hierarchy (Ancestors)

Digitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Officials

  • Katharine O White, MD, MPH

    Physicians for Reproductive Choice and Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 13, 2010

Study Start

January 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

May 1, 2013

Record last verified: 2013-04

Locations

US(1)