Use of an Occlusal Support Device During the Second Stage of Labor



Status:Recruiting
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:18 - 40
Updated:7/29/2018
Start Date:April 1, 2017
End Date:April 2019
Contact:Suzanne Darnell, MD
Email:darn0009@umn.edu
Phone:(612) 626-3111

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The primary objectives of this study are to determine if the use of an Occlusal Support
Device (OSD)(Mouthguard) can reduce the duration and intensity of the second stage of labor,
reduce the incidence of labor complications including Caesarian Sections and improve Apgar
scores in newborns

Prolonged labor, especially during the second stage of active expulsive effort (the pushing
phase), is associated with increased risk of maternal complications (e.g. tissue trauma,
postpartum hemorrhage, intra-amniotic infection). Developing an effective method to assist
and maximize maternal expulsion effort should be of great value in reducing the number of
complications, also including cesarean section or instrumental deliveries. Past studies
published in the dental literature have shown that specially designed oral appliances that
support the dental occlusion may increase the isometric strength of different muscle groups.
Increased strength of the neck muscles could improve efficiency of the Valsalva maneuver in
increasing intra-uterine pressure, and thus decreasing the duration of phase II of labor.
Nulliparous women with uncomplicated singleton pregnancy will be randomly assigned to either
the study group (Dental appliance) or the no dental appliance group. Duration of labor will
be measured for both phase I and phase II. Rates for cesarean section and instrument
deliveries and other complications will be charted as well as Apgar scores .

Inclusion Criteria:

- Nulliparous women

- Uncomplicated pregnancy

- Singleton pregnancy

Exclusion Criteria:

- Unable to provide informed consent or comply with study protocol,

- High risk and/or complicated pregnancy,

- Have multiple fetuses as diagnosed by ultrasound,

- Have extensive decay or multiple broken/missing teeth that will interfere with the
fabrication of an OSD
We found this trial at
1
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Minneapolis, Minnesota 55455
(612) 625-5000
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