Use of an Occlusal Support Device During the Second Stage of Labor

Study Overview
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Brief Summary
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The primary objectives of this study are to determine if the use of an Occlusal Support Device (OSD)(Mouthguard) can reduce the duration and intensity of the second stage of labor, reduce the incidence of labor complications including Caesarian Sections and improve Apgar scores in newborns

Detailed Description
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Prolonged labor, especially during the second stage of active expulsive effort (the pushing phase), is associated with increased risk of maternal complications (e.g. tissue trauma, postpartum hemorrhage, intra-amniotic infection). Developing an effective method to assist and maximize maternal expulsion effort should be of great value in reducing the number of complications, also including cesarean section or instrumental deliveries. Past studies published in the dental literature have shown that specially designed oral appliances that support the dental occlusion may increase the isometric strength of different muscle groups. Increased strength of the neck muscles could improve efficiency of the Valsalva maneuver in increasing intra-uterine pressure, and thus decreasing the duration of phase II of labor. Nulliparous women with uncomplicated singleton pregnancy will be randomly assigned to either the study group (Dental appliance) or the no dental appliance group. Duration of labor will be measured for both phase I and phase II. Rates for cesarean section and instrument deliveries and other complications will be charted as well as Apgar scores .

Official Title
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Use of an Occlusal Support Device During the Second Stage of Labor

Conditions
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Pregnancy

Intervention / Treatment
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* Device: Occlusal Support Device
* Other: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nulliparous women Uncomplicated pregnancy Singleton pregnancy Exclusion Criteria: Unable to provide informed consent or comply with study protocol, High risk and/or complicated pregnancy, Have multiple fetuses as diagnosed by ultrasound, Have extensive decay or multiple broken/missing teeth that will interfere with the fabrication of an OSD

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occlusal Support Device<br>Support device for women in labor | Device: Occlusal Support Device<br>* Bite plate<br>|
| Placebo Comparator: Control<br>No device given for women in labor | Other: Control<br>* Control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stage 2 Duration of Labor | Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor | Duration of labor | 
| Number of Participants With a Cesarian Section | Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections | Baseline | 
| Average Apgar Score | Determine if the use of an OSD can improve Apgar scores in newborns. The Apgar test is done by a doctor, midwife, or nurse. The provider examines the baby's: Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. Higher scores are better. Scores are added for a total ranging from 0-10. | at minute 1 and minute 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Labor and Delivery, Occlusal Support Device