MedDataX Logo

Dental Support Device During Breastfeeding as a Mean for Pain Control

NCT ID: NCT02639663

Last Updated: 2015-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breastfeeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

women whom are interested in breastfeeding and have not begun.

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

Group Type EXPERIMENTAL

dental device

Intervention Type DEVICE

Leboride

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 women that have already begun breast feeding

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.

Group Type EXPERIMENTAL

dental device

Intervention Type DEVICE

Leboride

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dental device

Leboride

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ariel many, professor

Role: PRINCIPAL_INVESTIGATOR

Tel Aviv Medical Center

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ariel many, professor

Role: CONTACT

Phone: 052-4266954

Email: [email protected]

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

559-15-TLV

Identifier Type: -

Identifier Source: org_study_id