Dental Support Device During Breastfeeding as a Mean for Pain Control

May 17, 2015 updated by: Yariv yogev

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Yariv Yogev

Study Locations

  • Israel
      • Petah tikva, Israel
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Maternal age 18-45 years.
  2. Normal vital signs.

Exclusion Criteria:

  1. Contraindications for breastfeeding.
  2. Significant systemic disease that cause pain or require chronic pain relief.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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: 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 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: 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of breastfeeding
Time Frame: 24 months
24 months
The rate of cessation of breastfeeding because of pain
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yariv yogev

Investigators

  • Principal Investigator: Yariv Yogev, professor, Director, Division of obstetrics and delivery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Anticipated)

April 1, 2017

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

March 23, 2015

First Submitted That Met QC Criteria

March 25, 2015

First Posted (Estimate)

March 26, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 0087-15-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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