PregnancyNCT00629369
Duration of Second Stage of Labor Wearing a Dental Occlusion Device
A study testing Extra 3 mouth guard, Shock doctor mouth guard v3.0 in people with Pregnancy, run by Mercy Medical Center at 1 site in United States.
Trial summary
Developing a method to maximize maternal expulsive effort should be of great value in reducing the number of cesarean section or instrumental deliveries. Various investigations have shown that use of an occlusal support device (OSD) increases the isometric strength of different muscle groups. Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Extra 3 mouth guard, Shock doctor mouth guard v3.0
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Dec 2007
- 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 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Primipara
- Term
- Singleton
- Cephalic presentation
- Reactive fetal heart rate pattern
- Functioning epidural anesthesia
Who cannot join
- Medical or obstetrical complications including intrauterine growth restriction
- Large for gestational age
- Uterine anomaly
- Uterine myomata
- Pre-eclampsia
- Diabetes mellitus
- Fetal anomaly
- Maternal heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Duration of Second Stage of Labor Wearing a Dental Occlusion Device: a Randomized Controlled Trial
Developing a method to maximize maternal expulsive effort should be of great value in reducing the number of cesarean section or instrumental deliveries. Various investigations have shown that use of an occlusal support device (OSD) increases the isometric strength of different muscle groups. The aim of our study was to investigate the role of an OSD in second stage pushing.
Read the detailed description
The increased use of epidural anesthesia during labor has lead to an increased incidence of prolonged second stage as an indication for cesarean section or instrumental delivery. The use of oxytocin has proven to be an effective method of augmentation of labor in such prolonged labor cases. However, despite oxytocin augmentation, there has been an increase in the number of cases that require cesarean section or instrumental delivery to effect delivery.
McRobert's maneuver, which is often used in to relieve shoulder dystocia, has recently been shown to increase intrauterine pressure approximately two-fold. However; it is an arduous position for the pregnant woman to maintain over a long period of time. Developing alternative methods to maximize expulsive forces, both uterine contractions and maternal expulsive effort, may be of great value in reducing the number of cesarean sections or instrumental deliveries.
Various researchers have investigated the effect of an occlusal support device (OSD) on the isometric strength of different muscle groups, e.g., neck, back, and extremities. The natural condition of dental occlusion, also known as the index of physical performance, has an affect on both muscle strength and body balance. When occlusal support is given to edentulous individuals they show improved physical exercise ability after the re-establishment of mandibular support. Patients whose dentition is in proper occlusion demonstrate greater endurance of isometric muscle strength than those who are in malocclusion. We hypothesize that optimization of dental occlusion by an OSD may improve muscle strength, leading to increased intrauterine pressure during the second stage in labor.
The aim of our study is to investigate whether the use of the OSD results in a shortened duration of the second stage of labor.
- Conditions
- Pregnancy
- Being tested
- Extra 3 mouth guard, Shock doctor mouth guard v3.0
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra 3 mouth guard, Shock doctor mouth guard v3.0Device
Also called extra 3 mouth guard (www.shieldsports.com), shock doctor mouth guard v3.0 (www.shockdoc.com)
Dental mouthguard, molded for each individual patient when in labor. The device is put in the water then in microwave for one minute to soften the device. The device is then applied to the patient's mouth for over 10 seconds to mold it.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | subjects with Occlusion Support Device with active pushing in the second stage of labor Receives: Device: Extra 3 mouth guard, Shock doctor mouth guard v3.0 |
| 2 | No intervention | Subjects without Occlusal Support Device with active pushing in the second stage of labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of the second stage of labor.
Measured: The duration of the second stage of labor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Robert O Atlas, MD, Principal investigator, Mercy Medical Center, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00629369
- Sponsor's protocol ID
- MMC2007-39
- Status last verified
- Mar 2008
- First submitted
- 25 Feb 2008
- Last updated
- 13 Mar 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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 19751326
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Duration of Second Stage of Labor Wearing a Dental Occlusion Device: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00629369
- Acronym / sponsor ID
- MMC2007-39
- Conditions
- Pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Mercy Medical CenterUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 6 Mar 2008 (estimated)
- 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.
Developing a method to maximize maternal expulsive effort should be of great value in reducing the number of cesarean section or instrumental deliveries. Various investigations have shown that use of an occlusal support device (OSD) increases the isometric strength of different muscle groups. The aim of our study was to investigate the role of an OSD in second stage pushing.
Detailed description
The increased use of epidural anesthesia during labor has lead to an increased incidence of prolonged second stage as an indication for cesarean section or instrumental delivery. The use of oxytocin has proven to be an effective method of augmentation of labor in such prolonged labor cases. However, despite oxytocin augmentation, there has been an increase in the number of cases that require cesarean section or instrumental delivery to effect delivery.
McRobert's maneuver, which is often used in to relieve shoulder dystocia, has recently been shown to increase intrauterine pressure approximately two-fold. However; it is an arduous position for the pregnant woman to maintain over a long period of time. Developing alternative methods to maximize expulsive forces, both uterine contractions and maternal expulsive effort, may be of great value in reducing the number of cesarean sections or instrumental deliveries.
Various researchers have investigated the effect of an occlusal support device (OSD) on the isometric strength of different muscle groups, e.g., neck, back, and extremities. The natural condition of dental occlusion, also known as the index of physical performance, has an affect on both muscle strength and body balance. When occlusal support is given to edentulous individuals they show improved physical exercise ability after the re-establishment of mandibular support. Patients whose dentition is in proper occlusion demonstrate greater endurance of isometric muscle strength than those who are in malocclusion. We hypothesize that optimization of dental occlusion by an OSD may improve muscle strength, leading to increased intrauterine pressure during the second stage in labor.
The aim of our study is to investigate whether the use of the OSD results in a shortened duration of the second stage of labor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Extra 3 mouth guard, Shock doctor mouth guard v3.0subjects with Occlusion Support Device with active pushing in the second stage of labor |
| 2 | No intervention | –Subjects without Occlusal Support Device with active pushing in the second stage of labor |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Primipara
- Term
- Singleton
- Cephalic presentation
- Reactive fetal heart rate pattern
Key exclusion criteria (8 listed)
- Medical or obstetrical complications including intrauterine growth restriction
- Large for gestational age
- Uterine anomaly
- Uterine myomata
- Pre-eclampsia
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 |
|---|---|---|
| Extra 3 mouth guard, Shock doctor mouth guard v3.0Also: extra 3 mouth guard (www.shieldsports.com), shock doctor mouth guard v3.0 (www.shockdoc.com)Dental mouthguard, molded for each individual patient when in labor. The device is put in the water then in microwave for one minute to soften the device. The device is then applied to the patient's mouth for over 10 seconds to mold it. | Device | A |
Primary outcome
The duration of the second stage of labor.
Time frame: The duration of the second stage of labor.
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 13 Mar 2008.
- Derived from this study: 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.
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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.
Robert O Atlas, MD principal investigator
Mercy Medical Center, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra 3 mouth guard, Shock doctor mouth guard v3.0 in people with Pregnancy, run by Mercy Medical Center 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 8 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 13 Mar 2008. 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?
The duration of the second stage of labor. (time frame: The duration of the second stage of labor.). 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 NCT00629369, which also lists 1 linked publication.
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 13 Mar 2008.