Duration of Second Stage of Labor Wearing a Dental Occlusion Device
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|ClinicalTrials.gov Identifier: NCT00629369|
Recruitment Status : Completed
First Posted : March 6, 2008
Last Update Posted : March 13, 2008
|Condition or disease||Intervention/treatment||Phase|
|Pregnancy||Device: Extra 3 mouth guard, Shock doctor mouth guard v3.0||Not Applicable|
The increased use of epidural anesthesia during labor has lead to an increased incidence of prolonged second stage as an indication for cesarean section or instrumental delivery. The use of oxytocin has proven to be an effective method of augmentation of labor in such prolonged labor cases. However, despite oxytocin augmentation, there has been an increase in the number of cases that require cesarean section or instrumental delivery to effect delivery.
McRobert's maneuver, which is often used in to relieve shoulder dystocia, has recently been shown to increase intrauterine pressure approximately two-fold. However; it is an arduous position for the pregnant woman to maintain over a long period of time. Developing alternative methods to maximize expulsive forces, both uterine contractions and maternal expulsive effort, may be of great value in reducing the number of cesarean sections or instrumental deliveries.
Various researchers have investigated the effect of an occlusal support device (OSD) on the isometric strength of different muscle groups, e.g., neck, back, and extremities. The natural condition of dental occlusion, also known as the index of physical performance, has an affect on both muscle strength and body balance. When occlusal support is given to edentulous individuals they show improved physical exercise ability after the re-establishment of mandibular support. Patients whose dentition is in proper occlusion demonstrate greater endurance of isometric muscle strength than those who are in malocclusion. We hypothesize that optimization of dental occlusion by an OSD may improve muscle strength, leading to increased intrauterine pressure during the second stage in labor.
The aim of our study is to investigate whether the use of the OSD results in a shortened duration of the second stage of labor.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||64 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Duration of Second Stage of Labor Wearing a Dental Occlusion Device: a Randomized Controlled Trial|
|Study Start Date :||October 2007|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||December 2007|
subjects with Occlusion Support Device with active pushing in the second stage of labor
Device: Extra 3 mouth guard, Shock doctor mouth guard v3.0
Dental mouthguard, molded for each individual patient when in labor. The device is put in the water then in microwave for one minute to soften the device. The device is then applied to the patient's mouth for over 10 seconds to mold it.
No Intervention: 2
Subjects without Occlusal Support Device with active pushing in the second stage of labor
- The duration of the second stage of labor. [ Time Frame: The duration of the second stage of labor. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00629369
|United States, Maryland|
|Mercy Medical Center|
|Baltimore, Maryland, United States, 21202|
|Principal Investigator:||Robert O Atlas, MD||Mercy Medical Center, Baltimore|