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

University of Minnesota (UMN)

Status: Completed

Conditions: Pregnancy

Treatments: Device: Occlusal Support Device; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02807493

DENT-2016-23918

Details and patient eligibility

About

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

Full description

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 .

Enrollment: 347 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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347 participants in 2 patient groups, including a placebo group

Occlusal Support Device

Experimental group

Description:

Support device for women in labor

Treatment:

Device: Occlusal Support Device

Control

Placebo Comparator group

Description:

No device given for women in labor

Treatment:

Other: Control