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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02807493
• Other study ID #: DENT-2016-23918
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: March 26, 2021

Study information

• Verified date: August 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 347
• Est. completion date: March 26, 2021
• Est. primary completion date: March 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy

Intervention

Device:
• Occlusal Support Device
Bite plate

Other:
• Control
Control group

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Number of Participants With a Cesarian Section	Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections	Baseline
Primary	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