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.

Study Overview

• Status: Unknown
• Conditions: Breastfeeding
• Intervention / Treatment: Device: dental device

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): 700
• Phase: Phase 3

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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; Leboride; Post-partum primi and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groupsIntervention 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.
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; Post-partum primi and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groupsIntervention 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.

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	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tel-Aviv Sourasky Medical Center
• Investigators: Principal Investigator: Ariel many, professor, Tel Aviv Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: December 21, 2015
• First Posted (Estimate): December 24, 2015

Study Record Updates

• Last Update Posted (Estimate): December 24, 2015
• Last Update Submitted That Met QC Criteria: December 21, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 559-15-TLV

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No