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

Clalit Health Services

Status and phase: Unknown; Phase 3

Conditions: Hypotension; Arrhythmia; ECG Changes

Treatments: Drug: Intra-amniotic injection of DIGOXIN

Study type: Interventional

Funder types: Other

Identifiers

NCT01951079

MMC130077-12CTIL

Details and patient eligibility

About

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 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.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

second trimester abortion , feticide

Experimental group

Description:

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

Treatment:

Drug: Intra-amniotic injection of DIGOXIN