Dental Support Device During Breastfeeding as a Mean for Pain Control

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dental Support Device During Breastfeeding as a Mean for Pain Control

Conditions
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Breastfeeding

Intervention / Treatment
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* Device: dental device


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention 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.<br>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 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 | Device: dental device<br>* 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.<br>|
| Experimental: Post-partum women that have already begun breast feeding<br>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: dental device<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of change in of the vas scores before and after using this device |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of breastfeeding |  | 24 months | 
| The rate of cessation of breastfeeding because of pain |  | 24 months |