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

Overview

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 .

Full Title of Study: “The Safety and Outcome of Intra-amniotic DIGOXIN Injection for Feticide Prior to Second Trimester Abortion”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2014

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.

Interventions

  • Drug: Intra-amniotic injection of DIGOXIN

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Meir Medical Center
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Zvi Klein, M.D, 972-9-7472544, kleinz@clalit.org.il

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