Duration of Second Stage of Labor Wearing a Dental Occlusion Device

Sponsor
Mercy Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00629369
Collaborator
(none)
64
1
2
2
31.9

Study Details

Study Description

Brief Summary

Developing a method to maximize maternal expulsive effort should be of great value in reducing the number of cesarean section or instrumental deliveries. Various investigations have shown that use of an occlusal support device (OSD) increases the isometric strength of different muscle groups. The aim of our study was to investigate the role of an OSD in second stage pushing.

Condition or Disease Intervention/Treatment Phase
  • Device: Extra 3 mouth guard, Shock doctor mouth guard v3.0
N/A

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
Randomized
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 :
Oct 1, 2007
Actual Primary Completion Date :
Dec 1, 2007
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Experimental: A

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.
Other Names:
  • extra 3 mouth guard (www.shieldsports.com)
  • shock doctor mouth guard v3.0 (www.shockdoc.com)
  • No Intervention: 2

    Subjects without Occlusal Support Device with active pushing in the second stage of labor

    Outcome Measures

    Primary Outcome Measures

    1. The duration of the second stage of labor. [The duration of the second stage of labor.]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Primipara

    • Term

    • Singleton

    • Cephalic presentation

    • Reactive fetal heart rate pattern

    • Functioning epidural anesthesia

    Exclusion Criteria:
    • Medical or obstetrical complications including intrauterine growth restriction

    • Large for gestational age

    • Uterine anomaly

    • Uterine myomata

    • Pre-eclampsia

    • Diabetes mellitus

    • Fetal anomaly

    • Maternal heart disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mercy Medical Center Baltimore Maryland United States 21202

    Sponsors and Collaborators

    • Mercy Medical Center

    Investigators

    • Principal Investigator: Robert O Atlas, MD, Mercy Medical Center, Baltimore

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00629369
    Other Study ID Numbers:
    • MMC2007-39
    First Posted:
    Mar 6, 2008
    Last Update Posted:
    Mar 13, 2008
    Last Verified:
    Mar 1, 2008

    Study Results

    No Results Posted as of Mar 13, 2008