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

The Safety and Outcome of Intra-amniotic DIGOXIN Injection for Feticide Prior to Second Trimester Abortion

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 .

Study Overview

• Status: Unknown
• Conditions: Arrhythmia; Hypotension; ECG Changes
• Intervention / Treatment: Drug: Intra-amniotic injection of DIGOXIN

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Zvi Klein, M.D; Phone Number: 972-9-7472544; Email: kleinz@clalit.org.il
• Study Contact Backup: Name: Regina agizim, M.D.; Phone Number: 972-9-7472561

Study Locations

• Israel
  • Kefar-saba, Israel
    • Dr. Zvi Klein
  • Kefar-saba, Israel
    • Sapir Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Meir Medical Center

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Anticipated): November 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: July 16, 2013
• First Submitted That Met QC Criteria: September 23, 2013
• First Posted (Estimate): September 26, 2013

Study Record Updates

• Last Update Posted (Estimate): September 26, 2013
• Last Update Submitted That Met QC Criteria: September 23, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: Digoxin; Intra-amniotic injection; feticide; second trimester abortion
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Digoxin
• Other Study ID Numbers: MMC130077-12CTIL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No