Dystocia; FetalNCT03520530
Mouth Guard Use in the Second Stage of Labor
A study testing Mouth Guard in people with Dystocia; Fetal and Labor Long, run by Christiana Care Health Services at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dystocia; Fetal, Labor Long, Cesarean Section, Affecting Fetus or Newborn
- What is being tested?
- Mouth Guard
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2018to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous women
- Age 18-55
- Presenting for delivery at Christiana Care Health Services
- Singleton pregnancy
- Cephalic pregnancy
- Term pregnancy
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health System
Newark, Delaware, 19713
About this study
Official title: Mouth Guard Use in the Second Stage of Labor: A Randomized Controlled Trial
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.
Read the 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.
- Being tested
- Mouth Guard
- Keywords
- second stage, spontaneous vaginal delivery
- Medical subject headings
- Dystocia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mouth GuardDevice
Patient will wear mouth guard while pushing in the second stage of labor
| Study group | Role | What they receive |
|---|---|---|
| Mouth Guard | Experimental | Patients will push in the second stage of labor without use of mouth guard Receives: Device: Mouth Guard |
| Control | No intervention | Patients will push in the second stage of labor without use of mouth guard |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of Second Stage of Labor
Time in minutes
Measured: Time from full cervical dilation (10cm) to delivery of the fetal head, approximately 2 hours
Secondary outcomes (7)
Mode of Delivery
Spontaneous vaginal delivery, assisted vaginal delivery, cesarean section
Measured: From time of randomization until delivery, up to one week
Instrumental Delivery
Type of instrument used in assisting delivery
Measured: From time of randomization until delivery, up to one week
Patient Satisfaction
Patient satisfaction with device as measured by survey
Measured: From time of randomization until delivery, up to one week
Perineal Laceration
Degree of perineal laceration with vaginal delivery
Measured: From time of randomization until delivery, up to one week
Apgar Score
Apgar scores of infants at 1, 5, and 10 minutes
Measured: From 0 to 10 minutes after delivery
Percentage of Time Spent Using Device
Provider will estimate percentage of second stage that patient used device
Measured: From time of randomization until delivery, up to one week
Neonatal ICU Admission Rate
Number of infants admitted to the NICU
Measured: From time of randomization until delivery, up to one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2018
- Study start9 May 2018
- Primary completion1 Dec 2019
- Study completion1 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dystocia; FetalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Shy, MD, Principal investigator, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03520530
- Sponsor's protocol ID
- 37133
- Status last verified
- Jul 2020
- First submitted
- 23 Mar 2018
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to submit for publication
Publications
Gabbe, Steven G., Jennifer R. Niebyl, Joe Leigh Simpson, and Garland D. Anderson. 1991. Obstetrics: normal and problem pregnancies. New York: Churchill Livingstone.
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.
PubMed 24901265Vidovic-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.
PubMed 26345152Farrington 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.
PubMed 21295384Arent, 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.
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.
PubMed 19751326Aviram 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.
PubMed 25777794
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mouth Guard Use in the Second Stage of Labor: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03520530
- Acronym / sponsor ID
- 37133
- Keywords
- second stage, spontaneous vaginal delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- 9 May 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Dec 2019 (actual)
- First posted
- 9 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Mouth Guard | Experimental | Device: Mouth GuardPatients will push in the second stage of labor without use of mouth guard |
| Control | No intervention | –Patients will push in the second stage of labor without use of mouth guard |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Nulliparous women
- Age 18-55
- Presenting for delivery at Christiana Care Health Services
- Singleton pregnancy
- Cephalic pregnancy
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mouth GuardPatient will wear mouth guard while pushing in the second stage of labor | Device | Mouth Guard |
Primary outcome
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
7 secondary outcomes
Mode of Delivery
Time frame: From time of randomization until delivery, up to one week
Instrumental Delivery
Time frame: From time of randomization until delivery, up to one week
Patient Satisfaction
Time frame: From time of randomization until delivery, up to one week
Perineal Laceration
Time frame: From time of randomization until delivery, up to one week
Apgar Score
Time frame: From 0 to 10 minutes after delivery
Percentage of Time Spent Using Device
Time frame: From time of randomization until delivery, up to one week
Neonatal ICU Admission Rate
Time frame: From time of randomization until delivery, up to one week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- BackgroundGabbe, Steven G., Jennifer R. Niebyl, Joe Leigh Simpson, and Garland D. Anderson. 1991. Obstetrics: normal and problem pregnancies. New York: Churchill Livingstone.
- Background: PubMed 24901265Laughon 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.
- Background: PubMed 26345152Vidovic-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.
- Background: PubMed 21295384Farrington 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.
- BackgroundArent, 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: PubMed 19751326Matsuo 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.
- Background: PubMed 25777794Aviram 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.
- Individual participant dataSharing planned: Yes. Plan to submit for publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Shy, MD principal investigator
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mouth Guard in people with Dystocia; Fetal and Labor Long, run by Christiana Care Health Services at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of Second Stage of Labor (time frame: Time from full cervical dilation (10cm) to delivery of the fetal head, approximately 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03520530, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.