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

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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)

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

Trial contacts and locations

2

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Central trial contact

Zvi Klein, M.D; Regina agizim, M.D.

Data sourced from clinicaltrials.gov

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