Dental Support Device During Breastfeeding as a Mean for Pain Control

Phase 3

• Conditions: Breastfeeding
• Interventions: Device: dental device

• Registration Number: NCT02639663
• Lead Sponsor: Tel-Aviv Sourasky Medical Center

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.

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 Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2015-12-21
• Last Update Submitted: 2015-12-21
• Study First Posted: 2015-12-24
• Last Update Posted: 2015-12-24
• Study Start: 2016-01
• Primary Completion: 2017-01
• Study Completion: 2018-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 700

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
women whom are interested in breastfeeding and have not begun.	dental device	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
Post-partum women that have already begun breast feeding	dental device	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.

Primary Outcome Measures

Name	Time	Method
Rate of change in of the vas scores before and after using this device	24 months

Secondary Outcome Measures

Name	Time	Method
Duration of breastfeeding	24 months
The rate of cessation of breastfeeding because of pain	24 months