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Dental Support Device During Breastfeeding as a Mean for Pain Control

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ClinicalTrials.gov Identifier: NCT02639663
Recruitment Status : Unknown
Verified December 2015 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center

Study Description
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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.


Condition or disease Intervention/treatment Phase
Breastfeeding Device: dental device Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 700 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dental Support Device During Breastfeeding as a Mean for Pain Control
Study Start Date : January 2016
Estimated Primary Completion Date : January 2017
Estimated Study Completion Date : January 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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

  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
 Device: dental device

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.
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.
 Device: dental device

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.


Outcome Measures
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Primary Outcome Measures :
  1. Rate of change in of the vas scores before and after using this device [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Duration of breastfeeding [ Time Frame: 24 months ]
  2. The rate of cessation of breastfeeding because of pain [ Time Frame: 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02639663


Contacts
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Contact: Ariel many, professor 052-4266954 arielm@tlvmc.gov.il

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
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Principal Investigator: Ariel many, professor Tel Aviv Medical Center
More Information
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Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT02639663    
Other Study ID Numbers: 559-15-TLV
First Posted: December 24, 2015    Key Record Dates
Last Update Posted: December 24, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No