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

• Sponsor: University of Minnesota (Other)
• Overall Status: Completed
• CT.gov ID: NCT02807493
• Collaborator: (none)
• Enrollment: 347
• Location: 1
• Arms: 2
• Actual Duration (Months): 47.8
• Patients Per Site Per Month: 7.3

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pregnancy	Device: Occlusal Support Device; Other: Control	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 347 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Use of an Occlusal Support Device During the Second Stage of Labor
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Mar 26, 2021
• Actual Study Completion Date: Mar 26, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of complications [Baseline]

   Determine if an Occlusal Support Device (OSD) can reduce the duration and intensity of the second stage of labor

2. Number of cesarians [Baseline]

   Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections

3. Difference in APGAR score [Baseline]

   Determine if the use of an OSD can improve Apgar scores in newborns.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

• University of Minnesota

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Minnesota
• ClinicalTrials.gov Identifier: NCT02807493
• Other Study ID Numbers: DENT-2016-23918
• First Posted: Jun 21, 2016
• Last Update Posted: Dec 28, 2021
• Last Verified: Dec 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by University of Minnesota: Pregnancy; Labor and Delivery; Occlusal Support Device
• Additional relevant MeSH terms: Salicylic Acid

Study Results

No Results Posted as of Dec 28, 2021