Use of an Occlusal Support Device During the Second Stage of Labor
1 other identifier
interventional
347
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Apr 2017
Longer than P75 for not_applicable pregnancy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 8, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedStudy Start
First participant enrolled
April 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2021
CompletedResults Posted
Study results publicly available
September 21, 2022
CompletedSeptember 21, 2022
August 1, 2022
4 years
June 8, 2016
March 11, 2022
August 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
Occlusal Support Device
EXPERIMENTALSupport device for women in labor
Control
PLACEBO COMPARATORNo device given for women in labor
Interventions
Eligibility Criteria
You may qualify if:
- Nulliparous women
- Uncomplicated pregnancy
- Singleton pregnancy
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Results Point of Contact
- Title
- James Gambucci
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
James E Gambucci, DDS
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2016
First Posted
June 21, 2016
Study Start
April 1, 2017
Primary Completion
March 26, 2021
Study Completion
March 26, 2021
Last Updated
September 21, 2022
Results First Posted
September 21, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share