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Mouth Guard Use in the Second Stage of Labor

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ClinicalTrials.gov Identifier: NCT03520530
Recruitment Status : Recruiting
First Posted : May 9, 2018
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services

Brief Summary:

Shortening the second stage of labor, the time spent pushing the baby out, is important for positive mother and infant's outcomes. Lack of progress of labor for any reason is the most common reason for cesarean section in women having their first baby and the second most common reason for cesarean section in women who have already had a baby. In 2014, a large study done across the United States showed increases in complications in both mother and infant when pushing was prolonged, including uterine infection, postpartum hemorrhage, more extensive vaginal tearing, shoulder dystocia, 5 minute Apgar score less than 4, infant admission to Neonatal Intensive Care Unit and neonatal infections. Therefore, the challenge is to consider alternative practices in order to maximize a mother's chance of a vaginal delivery and minimize these associated risks to both mother and baby.

Mouth guards are used primarily in contact sports, and have been demonstrated to reduce or prevent injury to the teeth. Additionally, it has been proposed that wearing a mouth guard increases the strength of different muscle groups. A recent randomized controlled pilot study including women with their first pregnancy using a dental support device (DSD) during the second stage of labor evaluated the length of the second stage and outcomes. They found a significant decrease of 38% in the length of pushing time in the group that used a DSD. Additionally, there was a decreased rate of cesarean section in this group, however a p-value was not reported. This study only included 64 patients. A second, larger trial did not find a significant difference in pushing time, however the rate of interventions such as a vacuum or forceps-assisted vaginal delivery and cesarean section were much higher in the control group due to prolonged pushing. The results of the second study are contradictory in nature, yet the researchers do not provide hypotheses into why this may be.

It is clear from the previously mentioned studies that further research is needed. Our hypothesis is that using such a device would help women to push more effectively during the second stage of labor thus shortening the time needed to push the baby out and increasing the rate of vaginal delivery. The purpose of this study is to determine whether wearing a mouth guard in the second stage of labor affects the length of the second stage of labor and improves mother & infant outcomes.


Condition or disease Intervention/treatment Phase
Dystocia; Fetal Labor Long Cesarean Section, Affecting Fetus or Newborn Device: Mouth Guard Not Applicable

Detailed Description:

Optimizing the second stage of labor is important for positive maternal and neonatal outcomes. Dystocia of labor refers to a lack of progress of labor for any reason, and it is the most common indication for cesarean delivery in nulliparous women and the second most common indication for cesarean delivery in multiparous women. In 2014, a large US multicenter cohort study showed increases in maternal and neonatal morbidities when the second stage was prolonged, including chorioamnionitis, postpartum hemorrhage, 3rd and 4th degree perineal laceration, shoulder dystocia, 5 minute Apgar score less than 4, neonatal admission to NICU and neonatal sepsis. Therefore, clinicians are challenged to consider alternative practices in order to maximize a mother's chance of a normal delivery and minimize these associated risks to both mother and baby.

Mouth guards are used primarily in contact sports, and have been demonstrated to reduce or prevent injury to the teeth. Most commonly made of synthetic polymers, mouth guards function as a shock-absorber. Even among sports medicine literature, there is a call for more research into use and education about protective gear. Previous studies have shown that wearing a mouth guard increases the isometric strength of different muscle groups. Recent studies have begun to explore whether wearing a similar style mouth guard will shorten the duration of the second stage of labor. A recent randomized controlled pilot study including nulliparous women using a dental support device (DSD) during the second stage evaluated the length of the second stage and outcome thereof. They defined the second stage of labor as the time between complete cervical dilation and fetal expulsion. They found a significant decrease of 38% in the length of the second stage in the group that used a DSD. Additionally, there was a decreased rate of cesarean section in this group, however a p-value was not reported. This study only included 64 patients. A second, larger trial also looking at nulliparous women did not find a significant difference in length of second stage of labor however the rate of obstetrical interventions such as operative vaginal delivery and cesarean section were much higher in the control group due to prolonged second stage of labor. Though the results of the second study are contradictory in nature, the researchers do not provide hypotheses into why this may be.

Our hypothesis is that using such a device would help women to push more effectively during the second stage of labor thus shortening the second stage and increasing the rate of spontaneous vaginal deliveries that do not require operative intervention. Developing a way to shorten the second stage of labor and reduce the number of cesarean sections or instrumental deliveries could reduce the morbidity of mothers and their infants and decrease health care spending.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a randomized controlled trial in which patients who make it to the second stage of labor will be randomized to wear a mouth guard while pushing during the second stage of labor or continue through the second stage of labor without a mouth guard. They will be randomized in a 1:1 fashion using RedCap.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Mouth Guard Use in the Second Stage of Labor: A Randomized Controlled Trial
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Arm Intervention/treatment
Experimental: Mouth Guard
Patients will push in the second stage of labor without use of mouth guard
Device: Mouth Guard
Patient will wear mouth guard while pushing in the second stage of labor

No Intervention: Control
Patients will push in the second stage of labor without use of mouth guard



Primary Outcome Measures :
  1. Time of Second Stage of Labor [ Time Frame: Time from full cervical dilation (10cm) to delivery of the fetal head, approximately 2 hours ]
    Time in minutes


Secondary Outcome Measures :
  1. Mode of Delivery [ Time Frame: From time of randomization until delivery, up to one week ]
    Spontaneous vaginal delivery, assisted vaginal delivery, cesarean section

  2. Instrumental Delivery [ Time Frame: From time of randomization until delivery, up to one week ]
    Type of instrument used in assisting delivery

  3. Patient Satisfaction [ Time Frame: From time of randomization until delivery, up to one week ]
    Patient satisfaction with device as measured by survey

  4. Perineal Laceration [ Time Frame: From time of randomization until delivery, up to one week ]
    Degree of perineal laceration with vaginal delivery

  5. Apgar Score [ Time Frame: From 0 to 10 minutes after delivery ]
    Apgar scores of infants at 1, 5, and 10 minutes

  6. Percentage of Time Spent Using Device [ Time Frame: From time of randomization until delivery, up to one week ]
    Provider will estimate percentage of second stage that patient used device

  7. Neonatal ICU Admission Rate [ Time Frame: From time of randomization until delivery, up to one week ]
    Number of infants admitted to the NICU



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Nulliparous women
  • Age 18-55
  • Presenting for delivery at Christiana Care Health Services
  • Singleton pregnancy
  • Cephalic pregnancy
  • Term pregnancy

Exclusion Criteria:

  • Multiple gestation
  • Known uterine anomalies, excluding resected uterine septums and fibroids
  • Estimated fetal weight less than 10th% for gestation age with abnormal umbilical dopplers
  • Estimated fetal weight less than the 5th percentile
  • History of cardiac disease requiring assisted second stage of labor
  • Oral implants, braces or active dental infection precluding mouth guard use
  • Preeclampsia with severe features treated with magnesium sulfate
  • History of shoulder dystocia
  • History of myomectomy
  • Maternal history of myasthenia gravis
  • Maternal history of sleep apnea with home CPAP use
  • Category III fetal heart tracing
  • Active vaginal bleeding consistent with placental abruption
  • Diagnosis of chorioamnionitis prior to start of second stage of labor
  • Participation in another interventional research study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03520530


Contacts
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Contact: Elizabeth Shy, MD 800-693-2273 elizabeth.r.shy@christianacare.org
Contact: Elizabeth Sushereba, MSN, CNM 800-693-2273 ESushereba@christianacare.org

Locations
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United States, Delaware
Christiana Care Health System Recruiting
Newark, Delaware, United States, 19713
Contact: Elizabeth Shy    800-693-2273    elizabeth.r.shy@christianacare.org   
Contact: Elizabeth Sushereba, MSN CNM    800 693 2273    esushereba@christianacare.org   
Principal Investigator: Elizabeth M Shy, MD         
Sponsors and Collaborators
Christiana Care Health Services
Investigators
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Principal Investigator: Elizabeth Shy, MD Christiana Care Health Services

Publications:
Gabbe, Steven G., Jennifer R. Niebyl, Joe Leigh Simpson, and Garland D. Anderson. 1991. Obstetrics: normal and problem pregnancies. New York: Churchill Livingstone.
Arent, S., McKenna, J. and Golem, D. (2010). Effects of a neuromuscular dentistry-designed mouthguard on muscular endurance and anaerobic power. Comparative Exercise Physiology, 7(02), pp.73-79.

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Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT03520530     History of Changes
Other Study ID Numbers: 37133
First Posted: May 9, 2018    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christiana Care Health Services:
second stage
spontaneous vaginal delivery
Additional relevant MeSH terms:
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Dystocia
Obstetric Labor Complications
Pregnancy Complications