Dental Support and the Second Stage of Labor Among Multiparous Women

NCT02642120 | Unknown Phase 3 DMC

• 1 other identifier: 0558-15- TLV
• Study Type: interventional
• Target: 500
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Second Stage of Labor

Outcome Measures

Primary Outcomes (1)

• 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.

  12 month

Secondary Outcomes (1)

• Patient 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: Dental device "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

Dental device "Laboraide" DEVICE

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

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Officials

• Ariel many, professor

  Tel Aviv Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ariel many, professor

CONTACT

052-4266954; arielm@tlvmc.gov.il

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director General for R&D

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: December 30, 2015
• Study Start: January 1, 2016
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2018
• Last Updated: December 30, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will share