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Duration of Second Stage of Labor Wearing a Dental Occlusion Device

This study has been completed.
Sponsor:
Information provided by:
Mercy Medical Center
ClinicalTrials.gov Identifier:
NCT00629369
First received: February 25, 2008
Last updated: March 7, 2008
Last verified: March 2008
History of Changes
  Purpose

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 Intervention
Pregnancy
 Device: Extra 3 mouth guard, Shock doctor mouth guard v3.0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Duration of Second Stage of Labor Wearing a Dental Occlusion Device: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Shock
U.S. FDA Resources

Further study details as provided by Mercy Medical Center:

Primary Outcome Measures:
  • The duration of the second stage of labor. [ Time Frame: The duration of the second stage of labor. ] [ Designated as safety issue: Yes ]

Enrollment: 64
Study Start Date: October 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00629369

Locations
United States, Maryland
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
  More Information

No publications provided by Mercy Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert O. Atlas, MD, Mercy Medical Center
ClinicalTrials.gov Identifier: NCT00629369     History of Changes
Other Study ID Numbers: MMC2007-39
Study First Received: February 25, 2008
Last Updated: March 7, 2008
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 21, 2013