Dental Support and the Second Stage of Labor Among Multiparous Women

Phase 3

• Conditions: Second Stage of Labor
• Interventions: Device: receive Laboraide

• Registration Number: NCT02344914
• Lead Sponsor: Yariv yogev

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.

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 Timeline

• Study First Submitted: 2014-12-21
• Status Verified: 2015-01
• Study First Submitted QC: 2015-01-18
• Study First Posted: 2015-01-26
• Last Update Submitted: 2015-05-17
• Last Update Posted: 2015-05-19
• Study Start: 2015-06
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
receive Laboraide	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.

Primary Outcome Measures

Name	Time	Method
Duration of the second stage of labor.	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.
Mode of delivery.	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.
VAS pain score.	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.

Trial Locations

Locations (1)

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel