Dental Support Device During Breastfeeding as a Mean for Pain Control
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 Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Maternal age 18-45 years. Normal vital signs.
Exclusion Criteria:
Contraindications for breastfeeding. Significant systemic disease that cause pain or require chronic pain relief.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: women whom are interested in breastfeeding and have not begun.
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
|
Leboride
|
|
Experimental: Post-partum women that have already begun breast feeding
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.
|
Leboride
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Rate of change in of the vas scores before and after using this device
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration of breastfeeding
Time Frame: 24 months
|
24 months
|
|
The rate of cessation of breastfeeding because of pain
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ariel many, professor, Tel Aviv Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 559-15-TLV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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