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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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01951079
Enrollment
100
Registered
2013-09-26
Start date
2013-11-30
Completion date
2014-12-31
Last updated
2013-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arrhythmia, ECG Changes, Hypotension

Keywords

Digoxin, Intra-amniotic injection, feticide, second trimester abortion

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.

Interventions

DRUGIntra-amniotic injection of DIGOXIN

Sponsors

Meir Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficiency of intra-amniotic Digoxin injection for second trimester feticidea yearTo measure the Success rate of intra-amniotic Digoxin injection for feticide prior to second trimester abortion

Countries

Israel

Contacts

Primary ContactZvi Klein, M.D
kleinz@clalit.org.il972-9-7472544
Backup ContactRegina agizim, M.D.
972-9-7472561

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026