NCT01951079

Brief Summary

In second trimester abortion above 22 weeks the investigators usually inject intra-cardiac Kcl for feticide. Digoxin intra-amniotic injection has been described in the literature in doses of 1-1.5 mg. with a success rate of about 80%, and up to 24 weeks. Our aim in this study is to investigate the safety and success rate of 1.5-2 mg. digoxin, intra-amniotic up to 30 weeks pregnancy .

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

Status
unknown

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

July 16, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 26, 2013

Status Verified

July 1, 2013

Enrollment Period

1 year

First QC Date

July 16, 2013

Last Update Submit

September 23, 2013

Conditions

ArrhythmiaECG ChangesHypotension

Keywords

DigoxinIntra-amniotic injectionfeticidesecond trimester abortion

Outcome Measures

Primary Outcomes (1)

  • Efficiency of intra-amniotic Digoxin injection for second trimester feticide

    To measure the Success rate of intra-amniotic Digoxin injection for feticide prior to second trimester abortion

    a year

Study Arms (1)

second trimester abortion , feticide

EXPERIMENTAL

all patients admitting to second trimester abortion above 22 weeks will be injected intra-amniotic DIGOXIN for feticide .

Drug: Intra-amniotic injection of DIGOXIN

Interventions

Intra-amniotic injection of DIGOXINDRUG
second trimester abortion , feticide

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy women with no medical, cardiac, hypertension, liver or renal problems - pregnant in their 20-30 week gestation,
  • that need to have abortion due to fetal anomalies or any other reason
  • need to have feticide prior to the procedure

You may not qualify if:

  • any patient with medical problem that may be a contra-indication to Digoxin
  • cardiac problems,
  • prior cardiac surgery,
  • liver or kidney disease,
  • hyper tension etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dr. Zvi Klein

Kfar Saba, Israel

Location

Sapir medical center

Kfar Saba, Israel

Location

MeSH Terms

Conditions

Arrhythmias, CardiacHypotension

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Central Study Contacts

Zvi Klein, M.D

CONTACT

972-9-7472544kleinz@clalit.org.il

Regina agizim, M.D.

CONTACT

972-9-7472561

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2013

First Posted

September 26, 2013

Study Start

November 1, 2013

Primary Completion

November 1, 2014

Study Completion

December 1, 2014

Last Updated

September 26, 2013

Record last verified: 2013-07

Locations

IL(2)