Dental Support Device During Breastfeeding as a Mean for Pain Control
1 other identifier
interventional
700
0 countries
N/A
Brief 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. This study hypothesis is that the Leboride use can reduce pain during breastfeeding, by that improve women's breastfeeding experience, and increase breastfeeding rates.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2015
CompletedFirst Posted
Study publicly available on registry
December 24, 2015
CompletedStudy Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedDecember 24, 2015
December 1, 2015
1 year
December 21, 2015
December 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of change in of the vas scores before and after using this device
24 months
Secondary Outcomes (2)
Duration of breastfeeding
24 months
The rate of cessation of breastfeeding because of pain
24 months
Study Arms (2)
women whom are interested in breastfeeding and have not begun.
EXPERIMENTALPost-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
EXPERIMENTAL2\. 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.
Interventions
Leboride 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.
Eligibility Criteria
You may qualify if:
- Maternal age 18-45 years. Normal vital signs.
You may not qualify if:
- Contraindications for breastfeeding. Significant systemic disease that cause pain or require chronic pain relief.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ariel many, professor
Tel Aviv Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 21, 2015
First Posted
December 24, 2015
Study Start
January 1, 2016
Primary Completion
January 1, 2017
Study Completion
January 1, 2018
Last Updated
December 24, 2015
Record last verified: 2015-12
Data Sharing
- IPD Sharing
- Will not share