N/A
N=347
Use of an Occlusal Support Device During the Second Stage of Labor
Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT02807493 ↗Enrolled (actual)
347
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: Stage 2 Duration of Labor — 120.2; 107 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Occlusal Support Device (Device); Control (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Minnesota
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Stage 2 Duration of Labor |
120.2; 107 | — |
| PRIMARY Number of Participants With a Cesarian Section |
12; 13 | — |
| PRIMARY Average Apgar Score |
7.8; 7.9; 8.8; 8.8 | — |
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
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02807493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.