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Mouth Guard Use in the Second Stage of Labor

Primary Purpose

Dystocia; Fetal, Labor Long, Cesarean Section, Affecting Fetus or Newborn

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mouth Guard
Sponsored by
Christiana Care Health Services
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dystocia; Fetal focused on measuring second stage, spontaneous vaginal delivery

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Christiana Care Health System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Mouth Guard

Control

Arm Description

Patients will push in the second stage of labor without use of mouth guard

Patients will push in the second stage of labor without use of mouth guard

Outcomes

Primary Outcome Measures

Time of Second Stage of Labor
Time in minutes

Secondary Outcome Measures

Mode of Delivery
Spontaneous vaginal delivery, assisted vaginal delivery, cesarean section
Instrumental Delivery
Type of instrument used in assisting delivery
Patient Satisfaction
Patient satisfaction with device as measured by survey
Perineal Laceration
Degree of perineal laceration with vaginal delivery
Apgar Score
Apgar scores of infants at 1, 5, and 10 minutes
Percentage of Time Spent Using Device
Provider will estimate percentage of second stage that patient used device
Neonatal ICU Admission Rate
Number of infants admitted to the NICU

Full Information

First Posted
March 23, 2018
Last Updated
July 31, 2020
Sponsor
Christiana Care Health Services
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1. Study Identification

Unique Protocol Identification Number
NCT03520530
Brief Title
Mouth Guard Use in the Second Stage of Labor
Official Title
Mouth Guard Use in the Second Stage of Labor: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 9, 2018 (Actual)
Primary Completion Date
December 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Christiana Care Health Services

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dystocia; Fetal, Labor Long, Cesarean Section, Affecting Fetus or Newborn
Keywords
second stage, spontaneous vaginal delivery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mouth Guard
Arm Type
Experimental
Arm Description
Patients will push in the second stage of labor without use of mouth guard
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients will push in the second stage of labor without use of mouth guard
Intervention Type
Device
Intervention Name(s)
Mouth Guard
Intervention Description
Patient will wear mouth guard while pushing in the second stage of labor
Primary Outcome Measure Information:
Title
Time of Second Stage of Labor
Description
Time in minutes
Time Frame
Time from full cervical dilation (10cm) to delivery of the fetal head, approximately 2 hours
Secondary Outcome Measure Information:
Title
Mode of Delivery
Description
Spontaneous vaginal delivery, assisted vaginal delivery, cesarean section
Time Frame
From time of randomization until delivery, up to one week
Title
Instrumental Delivery
Description
Type of instrument used in assisting delivery
Time Frame
From time of randomization until delivery, up to one week
Title
Patient Satisfaction
Description
Patient satisfaction with device as measured by survey
Time Frame
From time of randomization until delivery, up to one week
Title
Perineal Laceration
Description
Degree of perineal laceration with vaginal delivery
Time Frame
From time of randomization until delivery, up to one week
Title
Apgar Score
Description
Apgar scores of infants at 1, 5, and 10 minutes
Time Frame
From 0 to 10 minutes after delivery
Title
Percentage of Time Spent Using Device
Description
Provider will estimate percentage of second stage that patient used device
Time Frame
From time of randomization until delivery, up to one week
Title
Neonatal ICU Admission Rate
Description
Number of infants admitted to the NICU
Time Frame
From time of randomization until delivery, up to one week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Shy, MD
Organizational Affiliation
Christiana Care Health Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to submit for publication
IPD Sharing Time Frame
Within one year
Citations:
Citation
Gabbe, Steven G., Jennifer R. Niebyl, Joe Leigh Simpson, and Garland D. Anderson. 1991. Obstetrics: normal and problem pregnancies. New York: Churchill Livingstone.
Results Reference
background
PubMed Identifier
24901265
Citation
Laughon SK, Berghella V, Reddy UM, Sundaram R, Lu Z, Hoffman MK. Neonatal and maternal outcomes with prolonged second stage of labor. Obstet Gynecol. 2014 Jul;124(1):57-67. doi: 10.1097/AOG.0000000000000278. Erratum In: Obstet Gynecol. 2014 Oct;124(4):842.
Results Reference
background
PubMed Identifier
26345152
Citation
Vidovic-Stesevic V, Verna C, Krastl G, Kuhl S, Filippi A. Facial and Dental Injuries Facial and Dental Injuries in Karate. Swiss Dent J. 2015;125(7-8):810-4.
Results Reference
background
PubMed Identifier
21295384
Citation
Farrington T, Onambele-Pearson G, Taylor RL, Earl P, Winwood K. A review of facial protective equipment use in sport and the impact on injury incidence. Br J Oral Maxillofac Surg. 2012 Apr;50(3):233-8. doi: 10.1016/j.bjoms.2010.11.020. Epub 2011 Feb 3.
Results Reference
background
Citation
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.
Results Reference
background
PubMed Identifier
19751326
Citation
Matsuo K, Mudd JV, Kopelman JN, Atlas RO. Duration of the second stage of labor while wearing a dental support device: a pilot study. J Obstet Gynaecol Res. 2009 Aug;35(4):672-8. doi: 10.1111/j.1447-0756.2008.01010.x.
Results Reference
background
PubMed Identifier
25777794
Citation
Aviram A, Ashwal E, Hiersch L, Hadar E, Wiznitzer A, Yogev Y. The effect of intrapartum dental support use among nulliparous during the second stage of labor - a randomized controlled study. J Matern Fetal Neonatal Med. 2016 Mar;29(6):868-71. doi: 10.3109/14767058.2015.1024648. Epub 2015 Mar 19.
Results Reference
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Mouth Guard Use in the Second Stage of Labor

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