Dental Support and the Second Stage of Labor Among Multiparous Women

May 17, 2015 updated by: Yariv yogev
To assess if the use of the dental support device( DSD) Laboraide™ shortens the second stage of labor and decreased the rate of obstetrical interventions, and if it's use alleviate pain.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Several studies have demonstrated that a dental support device (DSD) may increase the isometric strength of different muscle groups (1-7). A preliminary pilot study of 32 women in 2009 showed that DSD may shorten the second stage of labor among nulliparous women (8) by increasing the expulsive efforts of the parturient. The study hypothesis was that DSD may decrease the length of the second stage of labor and decrease the need for obstetrical interventions such as cesarean delivery or operative vaginal delivery.

The Laboraide™ is a DSD developed specifically for use during labor. It is an inert device located between the jaws and does not interfere with speaking, breathing or any other oral activity during labor. It is a single use device, and is not transferred between women. We hypothesize that using this device can shorten the second stage of labor and decrease obstetrical intervention rate. We will also investigate it's efficiency in pain management.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Petah Tikva, Israel
      • Petah tikva, Israel
        • Rabin Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Singleton gestation
  2. Multiparous women
  3. Term gestation (>37+0/7 weeks)
  4. Signed written consent to participate in the study
  5. Maternal age 18-45 years
  6. Normal vital signs
  7. Noraml cardiotocography and biophysical profile at admission

Exclusion Criteria:

  1. Multiple gestation
  2. Nulliparous women
  3. preterm gestation (<37+0/7 weeks)
  4. Refusal to participate
  5. Maternal age <18 or > 45 years
  6. Normal vital signs
  7. Abnormal cardiotocography and biophysical profile at admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: receive Laboraide
After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package.
Device: receive Laboraide

After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package.

Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire.
No Intervention: do not receive Laboraide
After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of the second stage of labor.
Time Frame: 12 month

After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package.

Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire.
12 month
Mode of delivery.
Time Frame: 12 month

After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package.

Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire.
12 month
VAS pain score.
Time Frame: 12 month

After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package.

Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire.
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yariv yogev

Investigators

  • Principal Investigator: Yariv Yogev, professor, Director, Division of obstetrics and delivery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 21, 2014

First Submitted That Met QC Criteria

January 18, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

May 19, 2015

Last Update Submitted That Met QC Criteria

May 17, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 0523-14-RMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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