Mouth Guard Use in the Second Stage of Labor

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

Interventions

DEVICE

Mouth Guard

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

Sponsors & Collaborators

• Christiana Care Health Services

  lead OTHER

Principal Investigators

• Elizabeth Shy, MD · Christiana Care Health Services

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-05-09

Primary Completion

2019-12-01

Completion

2019-12-01

Countries

• United States

Study Locations