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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