Breastfeeding Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 700 |
Est. completion date | January 2018 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Tel-Aviv Sourasky Medical Center |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of change in of the vas scores before and after using this device | 24 months | No | |
Secondary | Duration of breastfeeding | 24 months | No | |
Secondary | The rate of cessation of breastfeeding because of pain | 24 months | No |
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