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OpenTrials
Completed

NCT Number: NCT02807493

Use of an Occlusal Support Device During the Second Stage of Labor

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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Key information

Conditions

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Occlusal Support Device

Device

Bite plate

Control

Other

Control group

Primary outcomes

  1. Stage 2 Duration of Labor

    Time frame: Duration of labor

    Determine if an Occlusal Support Device (OSD) can reduce the duration of the second stage of labor

  2. Number of Participants With a Cesarian Section

    Time frame: Baseline

    Determine if an OSD can reduce the incidence of labor complications including Caesarian Sections

  3. Average Apgar Score

    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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Jun 21, 2016
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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