NCT02344914

Brief Summary

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.

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
300

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

2 active sites

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

December 21, 2014

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 19, 2015

Status Verified

January 1, 2015

Enrollment Period

6 months

First QC Date

December 21, 2014

Last Update Submit

May 17, 2015

Conditions

Second Stage of Labor

Keywords

dental supportsecond stage of labor

Outcome Measures

Primary Outcomes (3)

  • Duration of the second stage of labor.

    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.

    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.

    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

Study Arms (2)

receive Laboraide

EXPERIMENTAL

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

do not receive Laboraide

NO INTERVENTION

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.

Interventions

receive LaboraideDEVICE

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.

receive Laboraide

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Multiple gestation
  • Nulliparous women
  • preterm gestation (\<37+0/7 weeks)
  • Refusal to participate
  • Maternal age \<18 or \> 45 years
  • Normal vital signs
  • Abnormal cardiotocography and biophysical profile at admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rabin Medical Center

Petah Tikva, Israel, Israel

Location

Rabin Medical Center

Petah Tikva, Israel, Israel

Location

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

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

December 21, 2014

First Posted

January 26, 2015

Study Start

June 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 19, 2015

Record last verified: 2015-01

Locations

IL(2)