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

NCT ID: NCT02807493

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 347 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2021-03-26

Brief Summary

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

Detailed 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 .

Conditions

Pregnancy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Occlusal Support Device

Support device for women in labor

Group Type: EXPERIMENTAL

Occlusal Support Device

Intervention Type: DEVICE

Bite plate

Control

No device given for women in labor

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: OTHER

Control group

Interventions

Occlusal Support Device

Bite plate

Intervention Type: DEVICE

Control

Control group

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James E Gambucci, DDS

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

DENT-2016-23918

Identifier Type: -

Identifier Source: org_study_id