Mouth Guard Use in the Second Stage of Labor

NCT03520530 | Completed

• 1 other identifier: 37133
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

second stage; spontaneous vaginal delivery

Outcome Measures

Primary Outcomes (1)

• Time of Second Stage of Labor

  Time in minutes

  Time from full cervical dilation (10cm) to delivery of the fetal head, approximately 2 hours

Secondary Outcomes (7)

• Mode of Delivery

  From time of randomization until delivery, up to one week

• Instrumental Delivery

  From time of randomization until delivery, up to one week

• Patient Satisfaction

  From time of randomization until delivery, up to one week

• Perineal Laceration

  From time of randomization until delivery, up to one week

• Apgar Score

  From 0 to 10 minutes after delivery

Study Arms (2)

Mouth Guard

EXPERIMENTAL

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

Device: Mouth Guard

Control

NO INTERVENTION

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

Interventions

Mouth Guard DEVICE

Patient will wear mouth guard while pushing in the second stage of labor

Mouth Guard

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christiana Care Health Services: lead

Study Sites (1)

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

Related Publications (7)

• Gabbe, Steven G., Jennifer R. Niebyl, Joe Leigh Simpson, and Garland D. Anderson. 1991. Obstetrics: normal and problem pregnancies. New York: Churchill Livingstone.

  BACKGROUND

• 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.

  PMID: 24901265 BACKGROUND

• Vidovic-Stesevic V, Verna C, Krastl G, Kuhl S, Filippi A. Facial and Dental Injuries in Karate. Swiss Dent J. 2015;125(7-8):810-4. doi: 10.61872/sdj-2015-07-08-01.

  PMID: 26345152 BACKGROUND

• 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.

  PMID: 21295384 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19751326 BACKGROUND

• 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.

  PMID: 25777794 BACKGROUND

MeSH Terms

Conditions

Dystocia

Interventions

Mouth Protectors

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Preventive Dentistry; Dentistry; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Elizabeth Shy, MD

  Christiana Care Health Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: May 9, 2018
• Study Start: May 9, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within one year

Locations

US (1)