Vacuum DeliveryEarly Phase 1NCT00956826
Continuous Fetal Monitoring During Vacuum Delivery
A Early Phase 1 study testing Agit Vacuum in people with Vacuum Delivery, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery. Read more about this study
- Who is it for?
- Ages 1 to 1 day
- Conditions the study is for
- Vacuum Delivery
- What is being tested?
- Agit Vacuum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2009to Dec 2010
- Phase
- Early Phase 1
- 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 1 to 1 day
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All fetuses at vacuum delivery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
David Mankuta, MD contact
Gal Nasi, BsC contact
About this study
Official title: Continuous Fetal Monitoring During Vacuum Delivery an Addition of a New Device
The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery.
Read the detailed description
The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery. The electrode is a standard one inserted in the vacuum device.
- Conditions
- Vacuum Delivery
- Being tested
- Agit Vacuum
- Keywords
- electrode vacuum delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Agit VacuumDevice
Also called Agit Vaccum
With an electrode and a regular vacuum device
| Study group | Role | What they receive |
|---|---|---|
| Electrode added to device | Experimental | With an electrode and a regular vacuum device Receives: Device: Agit Vacuum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of fetal heart rate monitoring in both arms
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionApr 2010 (estimated)
- Study completionDec 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vacuum DeliveryStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- David Mankuta, MD, Study chair, Hadassah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956826
- Sponsor's protocol ID
- fetal monitoring vaccum
- Other IDs
- FMV123
- Status last verified
- Aug 2009
- First submitted
- 19 Jul 2009
- Last updated
- 11 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Fetal Monitoring During Vacuum Delivery an Addition of a New Device
- ClinicalTrials.gov ID
- NCT00956826
- Acronym / sponsor ID
- fetal monitoring vaccum
- Conditions
- Vacuum Delivery
- Keywords
- electrode vacuum delivery
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 11 Aug 2009 (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.
The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery.
Detailed description
The investigators have added an additional electrode to the vacuum device for birth in which they can monitor the fetus during delivery. The electrode is a standard one inserted in the vacuum device.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Electrode added to device | Experimental | Device: Agit VacuumWith an electrode and a regular vacuum device |
Who may qualify
- Ages
- 1 to 1 day
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All fetuses at vacuum delivery
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Agit VacuumAlso: Agit VaccumWith an electrode and a regular vacuum device | Device | Electrode added to device |
Primary outcome
Quality of fetal heart rate monitoring in both arms
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2009.
Related trials for Vacuum Delivery
Not yet recruiting
Performance and Safety of Assisted Vaginal Delivery With the Odon Device™ Versus Vacuum Extraction
Pregnant Women
Enrolling by invitationObservational study
Learning Curves of Different Devices for Vaginal Birth on Mannequin
Forceps Delivery Affecting Fetus or Newborn, Ventouse Extraction;Liveborn
Active, not recruiting
Lateral Episiotomy or Not in Vacuum Assisted Delivery in Non-parous Women
Pelvic Floor Disorders, Fecal Incontinence
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.
David Mankuta, MD contact
Gal Nasi, BsC contact
David Mankuta, MD study chair
Hadassah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Agit Vacuum in people with Vacuum Delivery, run by Hadassah Medical Organization at 1 site 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 1 inclusion and 1 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 11 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 David Mankuta, MD (02 6776111), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of fetal heart rate monitoring in both arms (time frame: 12 month). 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 11 Aug 2009.