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

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01951079
• Other study ID #: MMC130077-12CTIL
• Status: Not yet recruiting
• Phase: Phase 3
• First received: July 16, 2013
• Last updated: September 23, 2013
• Start date: November 2013
• Est. completion date: December 2014

Study information

• Verified date: July 2013
• Source: Meir Medical Center
• Contact: Zvi Klein, M.D
• Phone: 972-9-7472544
• Email: kleinz[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel : Clalit Health Services
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arrhythmia
• ECG Changes
• Hypotension

Intervention

Drug:
• Intra-amniotic injection of DIGOXIN

Locations

Country	Name	City	State
Israel	Dr. Zvi Klein	Kefar-saba
Israel	Sapir medical center	Kefar-saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes