University of Minnesota
Minneapolis, Minnesota, 55455, United States
NCT Number: NCT02807493
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
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Notify Me18 year–40 year
Female
Interventional
Not applicable
Minneapolis, Minnesota, 55455, United States
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 .
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Bite plate
Control group
Time frame: Duration of labor
Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor
Time frame: Baseline
Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections
Time frame: 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.
University of Minnesota
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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