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

Phase 3

• Conditions: Arrhythmia; Hypotension; ECG Changes
• Interventions: Drug: Intra-amniotic injection of DIGOXIN

• Registration Number: NCT01951079
• Lead Sponsor: 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 .

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 Timeline

• Status Verified: 2013-07
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-09-23
• Last Update Submitted: 2013-09-23
• Study First Posted: 2013-09-26
• Last Update Posted: 2013-09-26
• Study Start: 2013-11
• Primary Completion: 2014-11
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
second trimester abortion , feticide	Intra-amniotic injection of DIGOXIN	all patients admitting to second trimester abortion above 22 weeks will be injected intra-amniotic DIGOXIN for feticide .

Primary Outcome Measures

Name	Time	Method
Efficiency of intra-amniotic Digoxin injection for second trimester feticide	a year	To measure the Success rate of intra-amniotic Digoxin injection for feticide prior to second trimester abortion

Trial Locations

Locations (2)

Sapir medical center; 🇮🇱 Kefar-saba, Israel

Dr. Zvi Klein; 🇮🇱 Kefar-saba, Israel