Duration of Second Stage of Labor Wearing a Dental Occlusion Device

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629369
• Other study ID #: MMC2007-39
• Status: Completed
• Phase: N/A
• First received: February 25, 2008
• Last updated: March 7, 2008
• Start date: October 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2008
• Source: Mercy Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Pregnancy

Intervention

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.

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Mercy Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of the second stage of labor.		The duration of the second stage of labor.	Yes