ArrhythmiaPhase 3NCT01951079
Intra Amniotic Injection of DIGOXIN for Feticide in Second Trimester Termination of Pregnancy
A Phase 3 study testing Intra-amniotic injection of DIGOXIN in people with Arrhythmia and ECG Changes, run by Meir Medical Center at 2 sites in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Arrhythmia, ECG Changes, Hypotension
- What is being tested?
- Intra-amniotic injection of DIGOXIN
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- Nov 2013to Dec 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Regina agizim, M.D. contact
About this study
Official title: The Safety and Outcome of Intra-amniotic DIGOXIN Injection for Feticide Prior to Second Trimester Abortion
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 .
Read the 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
- Arrhythmia, ECG Changes, Hypotension
- Being tested
- Intra-amniotic injection of DIGOXIN
- Keywords
- Digoxin, Intra-amniotic injection, feticide, second trimester abortion
- Medical subject headings
- Arrhythmias, Cardiac, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-amniotic injection of DIGOXINDrug
| Study group | Role | What they receive |
|---|---|---|
| second trimester abortion , feticide | Experimental | all patients admitting to second trimester abortion above 22 weeks will be injected intra-amniotic DIGOXIN for feticide . Receives: Drug: Intra-amniotic injection of DIGOXIN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of intra-amniotic Digoxin injection for second trimester feticide
To measure the Success rate of intra-amniotic Digoxin injection for feticide prior to second trimester abortion
Measured: a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01951079
- Sponsor's protocol ID
- MMC130077-12CTIL
- Status last verified
- Jul 2013
- First submitted
- 16 Jul 2013
- Last updated
- 26 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Outcome of Intra-amniotic DIGOXIN Injection for Feticide Prior to Second Trimester Abortion
- ClinicalTrials.gov ID
- NCT01951079
- Acronym / sponsor ID
- MMC130077-12CTIL
- Conditions
- Arrhythmia, ECG Changes, Hypotension
- Keywords
- Digoxin, Intra-amniotic injection, feticide, second trimester abortion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 26 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| second trimester abortion , feticide | Experimental | Drug: Intra-amniotic injection of DIGOXINall patients admitting to second trimester abortion above 22 weeks will be injected intra-amniotic DIGOXIN for feticide . |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intra-amniotic injection of DIGOXIN | Drug | second trimester abortion , feticide |
Primary outcome
Efficiency of intra-amniotic Digoxin injection for second trimester feticide
Time frame: a year
To measure the Success rate of intra-amniotic Digoxin injection for feticide prior to second trimester abortion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina agizim, M.D. contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Intra-amniotic injection of DIGOXIN in people with Arrhythmia and ECG Changes, run by Meir Medical Center at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zvi Klein, M.D (972-9-7472544, kleinz@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficiency of intra-amniotic Digoxin injection for second trimester feticide (time frame: a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2013.