Mouth Guard Use in the Second Stage of Labor
Completed · Not applicable
Conditions studied: Dystocia; Fetal, Labor Long, Cesarean Section, Affecting Fetus or Newborn
In brief
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.
Key facts
- Study ID
- NCT03520530
- Run by
- Christiana Care Health Services
- People needed
- 154
- Starts
- 2018-05-09
- Expected to finish
- 2019-12-01
- Last updated by the study team
- 2020-08-04
Who can join
Age: 18 and older, up to 55. Sex: female. Healthy volunteers: accepted.
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
Where it is running
- Christiana Care Health System — Newark, Delaware, United States
Full record on ClinicalTrials.gov
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