Pregnancy
Conditions
Keywords
Pregnancy, Labor and Delivery, Occlusal Support Device
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
Detailed 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 .
Interventions
DEVICEOcclusal Support Device
Bite plate
OTHERControl
Control group
Sponsors
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage 2 Duration of Labor | Duration of labor | Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor |
| Number of Participants With a Cesarian Section | Baseline | Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections |
| Average Apgar Score | at minute 1 and minute 5 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Occlusal Support Device Support device for women in labor
Occlusal Support Device: Bite plate | 174 |
| Control No device given for women in labor
Control: Control group | 173 |
| Total | 347 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 5 | 2 |
| Overall Study | C-Section Prior to Stage 2 of Labor | 31 | 39 |
| Overall Study | Lost to Follow-up | 6 | 0 |
| Overall Study | Other withdrawal | 17 | 0 |
| Overall Study | Physician Decision | 4 | 1 |
| Overall Study | Protocol Violation | 7 | 0 |
| Overall Study | Withdrawal by Subject | 17 | 10 |
Baseline characteristics
| Characteristic | Occlusal Support Device | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 174 Participants | 173 Participants | 347 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 17 Participants | 19 Participants | 36 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 11 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 9 Participants | 16 Participants | 25 Participants |
| Race (NIH/OMB) White | 134 Participants | 126 Participants | 260 Participants |
| Sex: Female, Male Female | 174 Participants | 173 Participants | 347 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 174 | 0 / 173 |
| other Total, other adverse events | 5 / 174 | 2 / 173 |
| serious Total, serious adverse events | 0 / 174 | 0 / 173 |
Outcome results
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.
Time frame: at minute 1 and minute 5
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Occlusal Support Device | Average Apgar Score | APGAR at min 1 | 7.8 score on a scale | Standard Deviation 1.6 |
| Occlusal Support Device | Average Apgar Score | APGAR at min 5 | 8.8 score on a scale | Standard Deviation 0.5 |
| Control | Average Apgar Score | APGAR at min 1 | 7.9 score on a scale | Standard Deviation 1.4 |
| Control | Average Apgar Score | APGAR at min 5 | 8.8 score on a scale | Standard Deviation 0.7 |
Primary
Number of Participants With a Cesarian Section
Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Occlusal Support Device | Number of Participants With a Cesarian Section | 12 participants |
| Control | Number of Participants With a Cesarian Section | 13 participants |
Primary
Stage 2 Duration of Labor
Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor
Time frame: Duration of labor
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Occlusal Support Device | Stage 2 Duration of Labor | 120.2 minutes | Standard Deviation 88.2 |
| Control | Stage 2 Duration of Labor | 107 minutes | Standard Deviation 83.9 |