Dental Support Device During Breastfeeding as a Mean for Pain Control

Yariv yogev

Status and phase: Unknown; Phase 3

Conditions: Breastfeeding

Treatments: Device: Leboride

Study type: Interventional

Funder types: Other

Identifiers

NCT02399774

0087-15-RMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,500 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,500 participants in 2 patient groups

Post-partum primi and multiparous women

Experimental group

Description:

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

Treatment:

Device: Leboride

Post-partum women that have already begun breast feeding

Experimental group

Description:

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.

Treatment:

Device: Leboride