## Protocol Section
### Identification Module
**NCT ID:** NCT01951079

**Brief Title:** Intra Amniotic Injection of DIGOXIN for Feticide in Second Trimester Termination of Pregnancy

**Official Title:** The Safety and Outcome of Intra-amniotic DIGOXIN Injection for Feticide Prior to Second Trimester Abortion

#### Organization Study ID Info
**ID:** MMC130077-12CTIL
#### Organization
**Class:** OTHER
**Full Name:** Meir Medical Center
### Status Module
#### Completion Date
**Date:** 2014-12

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2013-09-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-09-23

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2014-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2013-11

**Status Verified Date:** 2013-07

#### Study First Post Date
**Date:** 2013-09-26
**Type:** ESTIMATED
**Study First Submit Date:** 2013-07-16
**Study First Submit QC Date:** 2013-09-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Meir Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- Arrhythmia

- ECG Changes

- Hypotension

**Keywords:**

- Digoxin

- Intra-amniotic injection

- feticide

- second trimester abortion

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

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

**Intervention Names:**

- Drug: Intra-amniotic injection of DIGOXIN

**Label:** second trimester abortion , feticide

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- second trimester abortion , feticide

**Name:** Intra-amniotic injection of DIGOXIN

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** To measure the Success rate of intra-amniotic Digoxin injection for feticide prior to second trimester abortion

**Measure:** Efficiency of intra-amniotic Digoxin injection for second trimester feticide

**Time Frame:** a year

### Eligibility Module

**Eligibility Criteria:** 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.

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** kleinz@clalit.org.il

**Name:** Zvi Klein, M.D

**Phone:** 972-9-7472544

**Role:** CONTACT

**Contact 2:**

**Name:** Regina agizim, M.D.

**Phone:** 972-9-7472561

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Kefar-saba

**Country:** Israel

**Facility:** Dr. Zvi Klein

**Location 2:**

**City:** Kefar-saba

**Country:** Israel

**Facility:** Sapir medical center

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014652

- Term: Vascular Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M10072

- Name: Hypotension

- Relevance: HIGH

- As Found: Hypotension

- ID: M4453

- Name: Arrhythmias, Cardiac

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007022

- Term: Hypotension

### Intervention Browse Module - Ancestors

- ID: D000000889

- Term: Anti-Arrhythmia Agents

- ID: D000002316

- Term: Cardiotonic Agents

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000020011

- Term: Protective Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: AnArAg

- Name: Anti-Arrhythmia Agents

- Abbrev: CaAg

- Name: Cardiotonic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M7265

- Name: Digoxin

- Relevance: HIGH

- As Found: Plexus

- ID: M4213

- Name: Anti-Arrhythmia Agents

- Relevance: LOW

- As Found: Unknown

- ID: M5572

- Name: Cardiotonic Agents

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M21869

- Name: Protective Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000004077

- Term: Digoxin

### Misc Info Module

- Version Holder: 2024-05-24
