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Intra Amniotic Injection of DIGOXIN for Feticide in Second Trimester Termination of Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01951079
Recruitment Status : Unknown
Verified July 2013 by Meir Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center

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 .

Condition or disease Intervention/treatment Phase
Arrhythmia ECG Changes Hypotension Drug: Intra-amniotic injection of DIGOXIN Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Outcome of Intra-amniotic DIGOXIN Injection for Feticide Prior to Second Trimester Abortion
Study Start Date : November 2013
Estimated Primary Completion Date : November 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Digoxin

Arm Intervention/treatment
Experimental: second trimester abortion , feticide
all patients admitting to second trimester abortion above 22 weeks will be injected intra-amniotic DIGOXIN for feticide .
Drug: Intra-amniotic injection of DIGOXIN



Primary Outcome Measures :
  1. Efficiency of intra-amniotic Digoxin injection for second trimester feticide [ Time Frame: a year ]
    To measure the Success rate of intra-amniotic Digoxin injection for feticide prior to second trimester abortion



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01951079


Contacts
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Contact: Zvi Klein, M.D 972-9-7472544 kleinz@clalit.org.il
Contact: Regina agizim, M.D. 972-9-7472561

Locations
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Israel
Dr. Zvi Klein
Kefar-saba, Israel
Sapir medical center
Kefar-saba, Israel
Sponsors and Collaborators
Meir Medical Center

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Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01951079    
Other Study ID Numbers: MMC130077-12CTIL
First Posted: September 26, 2013    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: July 2013
Keywords provided by Meir Medical Center:
Digoxin
Intra-amniotic injection
feticide
second trimester abortion
Additional relevant MeSH terms:
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Hypotension
Vascular Diseases
Cardiovascular Diseases
Digoxin
Anti-Arrhythmia Agents
Cardiotonic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs