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

NCT02807493 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 347

Last updated 2022-09-21

Study results available
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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

Conditions

  • Pregnancy

Interventions

DEVICE

Occlusal Support Device

Bite plate

OTHER

Control

Control group

Sponsors & Collaborators

Principal Investigators

  • James E Gambucci, DDS · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-04-01
Primary Completion
2021-03-26
Completion
2021-03-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02807493 on ClinicalTrials.gov