NCT02399774

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,500

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

May 19, 2015

Status Verified

March 1, 2015

Enrollment Period

1.9 years

First QC Date

March 23, 2015

Last Update Submit

May 17, 2015

Conditions

Breastfeeding

Outcome Measures

Primary Outcomes (1)

  • Rate of change in of the vas scores before and after using this device

    24 months

Secondary Outcomes (2)

  • Duration of breastfeeding

    24 months

  • The rate of cessation of breastfeeding because of pain

    24 months

Study Arms (2)

Post-partum primi and multiparous women

EXPERIMENTAL

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

Device: Leboride

Post-partum women that have already begun breast feeding

EXPERIMENTAL

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: Leboride

Interventions

LeborideDEVICE

1. Post-partum primi 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 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.

Post-partum primi and multiparous womenPost-partum women that have already begun breast feeding

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Maternal age 18-45 years.
  • Normal vital signs.

You may not qualify if:

  • Contraindications for breastfeeding.
  • Significant systemic disease that cause pain or require chronic pain relief.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel, Israel

Location

Related Publications (1)

  • Deussen AR, Ashwood P, Martis R, Stewart F, Grzeskowiak LE. Relief of pain due to uterine cramping/involution after birth. Cochrane Database Syst Rev. 2020 Oct 20;10(10):CD004908. doi: 10.1002/14651858.CD004908.pub3.

    PMID: 33078388DERIVED

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Study Officials

  • Yariv Yogev, professor

    Director, Division of obstetrics and delivery

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yariv Yogev, professor

CONTACT

9723-9377490yarivy@clalit.org.il

Yariv Yogev

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Yariv Yogev, professor Director, division of obstetrics and delivery ward

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

May 19, 2015

Record last verified: 2015-03

Locations

IL(1)