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Completed

NCT Number: NCT00629369

Duration of Second Stage of Labor Wearing a Dental Occlusion Device

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.

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Key information

Conditions

Age range

16 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mercy Medical Center

Baltimore, Maryland, 21202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extra 3 mouth guard, Shock doctor mouth guard v3.0

Device

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)

Primary outcomes

  1. The duration of the second stage of labor.

    Time frame: The duration of the second stage of labor.

Sponsors and collaborators

Lead sponsor

Mercy Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 6, 2008
Registry last updated
Mar 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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