BreastfeedingPhase 3NCT02639663
Dental Support Device During Breastfeeding as a Mean for Pain Control
A Phase 3 study testing dental device in people with Breastfeeding, run by Tel-Aviv Sourasky Medical Center.
Trial summary
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- dental device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2018
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Maternal age 18-45 years. Normal vital signs.
Who cannot join
- Contraindications for breastfeeding. Significant systemic disease that cause pain or require chronic pain relief.
Trial locations and contacts
No sites are listed yet.
About this study
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.
This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
Read the detailed description
Dental support device is effective in increasing isometric force in different muscle contraction [1-7]. In 2009 an avant-garde study [8] found in a small cohort that dental support device during labor, can shorten the second stage and reduce obstetrical interventions such as operative delivery and cesarean section. In this stage the woman has to contract muscles in order to push the fetus through the birth canal.
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.
This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
- Conditions
- Breastfeeding
- Being tested
- dental device
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dental deviceDevice
Leboride
- Post-partum primi and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups
- Intervention group: participants will receive the dental device and be instructed to use it during breastfeeding.
- Control group: participants will not receive any device for breastfeeding pain control
- Post-partum women that have already begun breast feeding, will receive the dental device and each woman will be serve as her own control (breastfeeding before and after the use of the dental device.
| Study group | Role | What they receive |
|---|---|---|
| women whom are interested in breastfeeding and have not begun. | Experimental | Post-partum primi and multiparous women Post-partum primipara and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups
1. Intervention group: participants will receive the dental device and be instructed to use it during breastfeeding.
2. Control group: participants will not receive any device for breastfeeding pain control Receives: Device: dental device |
| Post-partum women that have already begun breast feeding | Experimental | 2. Post-partum women that have already begun breast feeding, will receive the dental device and each woman will be serve as her own control (breastfeeding before and after the use of the dental device. Receives: Device: dental device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of change in of the vas scores before and after using this device
Measured: 24 months
Secondary outcomes (2)
Duration of breastfeeding
Measured: 24 months
The rate of cessation of breastfeeding because of pain
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionJan 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ariel many, professor, Principal investigator, Tel Aviv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639663
- Sponsor's protocol ID
- 559-15-TLV
- Status last verified
- Dec 2015
- First submitted
- 21 Dec 2015
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Support Device During Breastfeeding as a Mean for Pain Control
- ClinicalTrials.gov ID
- NCT02639663
- Acronym / sponsor ID
- 559-15-TLV
- Conditions
- Breastfeeding
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2016
- Primary completion
- Jan 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 24 Dec 2015 (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.
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.
This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
Detailed description
Dental support device is effective in increasing isometric force in different muscle contraction [1-7]. In 2009 an avant-garde study [8] found in a small cohort that dental support device during labor, can shorten the second stage and reduce obstetrical interventions such as operative delivery and cesarean section. In this stage the woman has to contract muscles in order to push the fetus through the birth canal.
Leboride is a dental support device that was developed for reducing pain during active labor. It is made of an inert material, placed in the woman's mouth and does not disturb breathing, talking, or any other activity expected during labor. It is a single-use device, each user receives a new one.
This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women whom are interested in breastfeeding and have not begun. | Experimental | Device: dental devicePost-partum primi and multiparous women Post-partum primipara and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups 1. Intervention group: participants will receive the dental device and be instructed to use it during breastfeeding. 2. Control group: participants will not receive any device for breastfeeding pain control |
| Post-partum women that have already begun breast feeding | Experimental | Device: dental device2. Post-partum women that have already begun breast feeding, will receive the dental device and each woman will be serve as her own control (breastfeeding before and after the use of the dental device. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Maternal age 18-45 years. Normal vital signs.
Key exclusion criteria (1 listed)
- Contraindications for breastfeeding. Significant systemic disease that cause pain or require chronic pain relief.
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 |
|---|---|---|
| dental deviceLeboride 1. Post-partum primi and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups 1. Intervention group: participants will receive the dental device and be instructed to use it during breastfeeding. 2. Control group: participants will not receive any device for breastfeeding pain control 2. Post-partum women that have already begun breast feeding, will receive the dental device and each woman will be serve as her own control (breastfeeding before and after the use of the dental device. | Device | Post-partum women that have already begun breast feeding, women whom are interested in breastfeeding and have not begun. |
Primary outcome
Rate of change in of the vas scores before and after using this device
Time frame: 24 months
2 secondary outcomes
Duration of breastfeeding
Time frame: 24 months
The rate of cessation of breastfeeding because of pain
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Individual participant dataSharing planned: No
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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.
Ariel many, professor principal investigator
Tel Aviv Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dental device in people with Breastfeeding, run by Tel-Aviv Sourasky Medical Center.
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 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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 Ariel many, professor (052-4266954, arielm@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of change in of the vas scores before and after using this device (time frame: 24 months). 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 24 Dec 2015.