Dental Support and the Second Stage of Labor Among Multiparous Women

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Second Stage of Labor

Intervention / Treatment
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* Device: Dental device Laboraide


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Receive Laboraide<br>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<br>* 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.<br>|
| No Intervention: Do not receive Laboraide<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction (questionnaire) | Following delivery, patients will be asked to complete a satisfaction questionnaire. | 12 month |