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

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

Study Overview

• Status: Completed
• Conditions: Pregnancy
• Intervention / Treatment: Device: Occlusal Support Device; Other: Control

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 .

• Study Type: Interventional
• Enrollment (Actual): 347
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Occlusal Support Device; Support device for women in labor	Device: Occlusal Support Device; Bite plate
Placebo Comparator: Control; No device given for women in labor	Other: Control; Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stage 2 Duration of Labor	Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor	Duration of labor
Number of Participants With a Cesarian Section	Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections	Baseline
Average Apgar Score	Determine if the use of an OSD can improve Apgar scores in newborns. The Apgar test is done by a doctor, midwife, or nurse. The provider examines the baby's: Breathing effort Heart rate Muscle tone Reflexes Skin color Each category is scored with 0, 1, or 2, depending on the observed condition. Higher scores are better. Scores are added for a total ranging from 0-10.	at minute 1 and minute 5

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: James E Gambucci, DDS, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): March 26, 2021
• Study Completion (Actual): March 26, 2021

Study Registration Dates

• First Submitted: June 8, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Pregnancy; Labor and Delivery; Occlusal Support Device
• Additional Relevant MeSH Terms: Anti-Infective Agents; Dermatologic Agents; Antifungal Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: DENT-2016-23918

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No