Dental Support Device During Breastfeeding as a Mean for Pain Control

Breastfeeding Clinical Trial

Official title:

Dental Support Device During Breastfeeding as a Mean for Pain Control

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02639663
• Other study ID #: 559-15-TLV
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 21, 2015
• Last updated: December 21, 2015
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: December 2015
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ariel many, professor
• Phone: 052-4266954
• Email: arielm[@]tlvmc.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 700
• Est. completion date: January 2018
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breastfeeding

Intervention

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 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 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of change in of the vas scores before and after using this device		24 months	No
Secondary	Duration of breastfeeding		24 months	No
Secondary	The rate of cessation of breastfeeding because of pain		24 months	No