Dental Support and the Second Stage of Labor Among Multiparous Women

Second Stage of Labor Clinical Trial

Official title: Dental Support and the Second Stage of Labor Among Multiparous Women

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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. The investigators hypothesize that using this device can shorten the second stage of labor and decrease obstetrical intervention rate. The researchers will also investigate it's efficiency in pain management. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Second Stage of Labor

• NCT number: NCT02642120
• Study type: Interventional
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Ariel many, professor
• Phone: 052-4266954
• Email: arielm@tlvmc.gov.il
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2016
• Completion date: January 2018