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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
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 .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occlusal Support Device | Experimental | Support device for women in labor |
|
| Control | Placebo Comparator | No device given for women in labor |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Occlusal Support Device | Device | Bite plate |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James E Gambucci, DDS | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Occlusal Support Device | Support device for women in labor Occlusal Support Device: Bite plate |
| FG001 | Control | No device given for women in labor Control: Control group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Occlusal Support Device | Support device for women in labor Occlusal Support Device: Bite plate |
| BG001 | Control | No device given for women in labor Control: Control group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Stage 2 Duration of Labor | Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor | Posted | Mean | Standard Deviation | minutes | Duration of labor |
|
|
Duration of labor
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Occlusal Support Device | Support device for women in labor Occlusal Support Device: Bite plate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Miscarriage | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| James Gambucci | University of Minnesota | 612-625-7448 | gambu001@umn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 30, 2018 | Jul 15, 2022 | Prot_SAP_006.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 30, 2020 | Apr 13, 2022 | ICF_003.pdf |
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| Control |
| Other |
Control group |
|
| Physician Decision |
|
| Protocol Violation |
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| Withdrawal by Subject |
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| Other withdrawal |
|
| C-Section Prior to Stage 2 of Labor |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Number of Participants With a Cesarian Section | Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections | Posted | Number | participants | 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. | Posted | Mean | Standard Deviation | score on a scale | at minute 1 and minute 5 |
|
|
|
| 0 |
| 174 |
| 0 |
| 174 |
| 5 |
| 174 |
| EG001 | Control | No device given for women in labor Control: Control group | 0 | 173 | 0 | 173 | 2 | 173 |
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