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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Post-partum primi and multiparous women | Experimental | Post-partum primipara and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leboride | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of change in of the vas scores before and after using this device | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of breastfeeding | 24 months | |
| The rate of cessation of breastfeeding because of pain | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yariv Yogev, professor | Contact | 9723-9377490 | yarivy@clalit.org.il | |
| Yariv Yogev | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Yariv Yogev, professor | Director, Division of obstetrics and delivery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rabin Medical Center | Petah Tikva | Israel | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33078388 | Derived | Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3. |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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