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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02639663
Other study ID # 559-15-TLV
Secondary ID
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


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
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