MedDataX Logo

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

NCT ID: NCT01951079

Last Updated: 2013-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

* 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Arrhythmia ECG Changes Hypotension

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Digoxin Intra-amniotic injection feticide second trimester abortion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

second trimester abortion , feticide

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

Group Type EXPERIMENTAL

Intra-amniotic injection of DIGOXIN

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intra-amniotic injection of DIGOXIN

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dr. Zvi Klein

Kfar Saba, , Israel

Site Status

Sapir medical center

Kfar Saba, , Israel

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Israel

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Zvi Klein, M.D

Role: CONTACT

Phone: 972-9-7472544

Email: [email protected]

Regina agizim, M.D.

Role: CONTACT

Phone: 972-9-7472561

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MMC130077-12CTIL

Identifier Type: -

Identifier Source: org_study_id