Duration of Second Stage of Labor Wearing a Dental Occlusion Device

Duration of Second Stage of Labor Wearing a Dental Occlusion Device: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: Extra 3 mouth guard, Shock doctor mouth guard v3.0

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 Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Mercy Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The duration of the second stage of labor.	The duration of the second stage of labor.

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Matsuo K, Mudd JV, Kopelman JN, Atlas RO. Duration of the second stage of labor while wearing a dental support device: a pilot study. J Obstet Gynaecol Res. 2009 Aug;35(4):672-8. doi: 10.1111/j.1447-0756.2008.01010.x.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: February 25, 2008
• First Submitted That Met QC Criteria: March 5, 2008
• First Posted (Estimate): March 6, 2008

Study Record Updates

• Last Update Posted (Estimate): March 13, 2008
• Last Update Submitted That Met QC Criteria: March 7, 2008
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Other Study ID Numbers: MMC2007-39