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

Not Applicable

Completed

Brief Summary: 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: 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 .

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Control	Control	No device given for women in labor
Occlusal Support Device	Occlusal Support Device	Support device for women in labor

Primary Outcome Measures

Name	Time	Method
Average Apgar Score	at minute 1 and minute 5	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.
Stage 2 Duration of Labor	Duration of labor	Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor
Number of Participants With a Cesarian Section	Baseline	Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections