Back to resultsIntra Amniotic Injection of DIGOXIN for Feticide in Second Trimester Termination of Pregnancy
Primary Purpose
Arrhythmia, ECG Changes, Hypotension
Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Intra-amniotic injection of DIGOXIN
Sponsored by
About this trial
This is an interventional treatment trial for Arrhythmia focused on measuring Digoxin, Intra-amniotic injection, feticide, second trimester abortion
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- Dr. Zvi Klein
- Sapir medical center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
second trimester abortion , feticide
Arm Description
all patients admitting to second trimester abortion above 22 weeks will be injected intra-amniotic DIGOXIN for feticide .
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01951079
Brief Title
Intra Amniotic Injection of DIGOXIN for Feticide in Second Trimester Termination of Pregnancy
Official Title
The Safety and Outcome of Intra-amniotic DIGOXIN Injection for Feticide Prior to Second Trimester Abortion
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meir Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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 .
Detailed Description
The digoxin will be injected intra-amniotic with U.S guided, trying to avoid any placental passage or intravascular injection /
Any patient will have prior to the procedure a full examination including E.C.G and cardiac clearance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arrhythmia, ECG Changes, Hypotension
Keywords
Digoxin, Intra-amniotic injection, feticide, second trimester abortion
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
second trimester abortion , feticide
Arm Type
Experimental
Arm Description
all patients admitting to second trimester abortion above 22 weeks will be injected intra-amniotic DIGOXIN for feticide .
Intervention Type
Drug
Intervention Name(s)
Intra-amniotic injection of DIGOXIN
Primary Outcome Measure Information:
Title
Efficiency of intra-amniotic Digoxin injection for second trimester feticide
Description
To measure the Success rate of intra-amniotic Digoxin injection for feticide prior to second trimester abortion
Time Frame
a year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zvi Klein, M.D
Phone
972-9-7472544
Email
kleinz@clalit.org.il
First Name & Middle Initial & Last Name or Official Title & Degree
Regina agizim, M.D.
Phone
972-9-7472561
Facility Information:
Facility Name
Dr. Zvi Klein
City
Kefar-saba
Country
Israel
Facility Name
Sapir medical center
City
Kefar-saba
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Intra Amniotic Injection of DIGOXIN for Feticide in Second Trimester Termination of Pregnancy
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