LaborNCT03138798
Dental Support Device in the Second Stage of Labor
A study testing Laboraide TM dental support device in people with Labor, run by Angela Bianco at 1 site in United States.
Trial summary
Obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice may lead to either operative delivery (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor
- What is being tested?
- Laboraide TM dental support device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 348 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2017to 7 Nov 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nulliparous women
- Non-anomalous fetus
- Singleton fetus
- Vertex presentation
- In the first phase of labor
- Full term gestation (>=37w0d)
- Maternal age 18-64 years
Who cannot join
- Multiparity
- History of prior uterine surgery such as cesarean section or myomectomy
- Unexplained vaginal bleeding
- Latex allergy
- Contraindication to vaginal delivery
- Pregestational or Gestational Diabetes
Show all 11Show fewer
- Fetal growth restriction
- Fetus with suspected macrosomia
- Prematurity (<37 weeks gestational age)
- Multiple gestation
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A Randomized Controlled Trial
Obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice may lead to either operative delivery (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited evidence suggests that dental support devices (DSD) may improve lead to shortened labor by allowing patients to push more effectively.
Read the detailed description
In an effort to reduce the rate of cesarean section, obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice is not without risks and may lead to either operative delivery (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited evidence suggests that dental support devices (DSD) may improve maternal valsalva and lead to a shortened second stage of labor by allowing them to push more effectively. Previous studies have been underpowered to find statistically significant results.
The Icahn School of Medicine at Mount Sinai has a unique and heterogeneous inner-city population of laboring mothers with marked rates of maternal obesity. The objective is to conduct a randomized controlled trial in which nulliparous patients are asked to use the LaboraideTM, a DSD designed for laboring women, while pushing with contractions in the second stage of labor.
- Conditions
- Labor
- Being tested
- Laboraide TM dental support device
- Keywords
- Labor, Second stage, Dental device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboraide TM dental support deviceDevice
Also called Dental Device, Dental Support Device
Patients will give consent in the first stage of labor. Subsequently a randomization will be performed using sealed envelopes opened at the time of pushing in the second stage of labor. Women assigned to Group A will received a sealed Laboraide TM package. Duration of the second stage and time spent pushing will be recorded. Obstetric management will not be altered by group assignment. Following delivery, patients assigned to Group A will complete a patient satisfaction survey.
| Study group | Role | What they receive |
|---|---|---|
| Laboraide TM dental support device | Experimental | Receive Laboraide Receives: Device: Laboraide TM dental support device |
| Control Group | No intervention | Patients will give consent in the first stage of labor. Subsequently, randomization will be performed using sealed envelopes opened at the time of pushing in the second stage of labor. Women assigned to Group B will not receive a Laboraide TM dental support device. Duration of the second stage and time spent pushing will be recorded. Obstetric management will not be altered by group assignment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dilation Duration of Second Stage of Labor Time
At the time of pushing in the second stage of labor, the time from full dilation to delivery during the second stage of labor in patients with vaginal delivery (spontaneous, vacuum, forceps included). Intention to treat analysis.
Measured: Up to 3 hours
Delivery Time
The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed.
Measured: An average of 75 minutes
Secondary outcomes (8)
Dental Support Device Comfort and Patient Satisfaction
After delivery patients assigned to the intervention group completed a comfort and satisfaction survey which consisted of three questions and given choices from strongly disagree to strongly agree
Measured: Post-Op Day 1
Mode of Delivery
Delivery Outcomes: Mode of delivery
Measured: Day 1
Estimated Blood Loss
Estimated blood loss (EBL) during delivery
Measured: Day 1
Number of Participants With Post-partum Hemorrhage
Number of participants with post-partum hemorrhage caused by uterine atony which is a loss of tone in the uterine musculature.
Measured: Day 1
Number of Participants With Chorioamnionitis
Chorioamnionitis - an intra-amniotic infection (IAI) is an inflammation of the fetal membranes (amnion and chorion) due to a bacterial infection.
Measured: Day 1
Neonatal Birth Weight
Neonatal outcomes - birth weight
Measured: Day 1
Neonatal Sex
Neonatal outcomes - Number of male neonatal sex
Measured: Day 1
Number of NICU Admission
Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2017
- Study start6 Jan 2017
- Primary completion7 Nov 2017
- Study completion7 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for LaborStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will give consent in the first stage of labor. Randomization will then be performed using sealed envelopes at the time of pushing in the second stage of labor. Duration of the second stage and time spent pushing will be recorded for both groups.
- Masking
- None (open label)
- Enrolment
- 348 participants (actual)
Sponsor and investigators
- Lead sponsor
- Angela Bianco
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Sponsor-investigator, Angela Bianco, Icahn School of Medicine at Mount Sinai
- Investigators
- Angela Bianco, MD, Principal investigator, Icahn School of Medicine at Mount SinaiEric Bergh, MD, Study director, Ichan School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03138798
- Sponsor's protocol ID
- GCO 16-2121
- Status last verified
- Nov 2018
- First submitted
- 6 Apr 2017
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03138798
- Acronym / sponsor ID
- GCO 16-2121
- Conditions
- Labor
- Keywords
- Labor, Second stage, Dental device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 348 participants (actual)
- Lead sponsor
- Angela BiancoUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- 6 Jan 2017 (actual)
- Primary completion
- 7 Nov 2017 (actual)
- Study completion
- 7 Nov 2017 (actual)
- First posted
- 3 May 2017 (actual)
- Results
- Posted 11 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice may lead to either operative delivery (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited evidence suggests that dental support devices (DSD) may improve lead to shortened labor by allowing patients to push more effectively.
Detailed description
In an effort to reduce the rate of cesarean section, obstetric practices now allow for prolonged second stage of labor to accomplish vaginal delivery. However, this practice is not without risks and may lead to either operative delivery (vacuum or forceps assisted delivery) or cesarean section with significant maternal/neonatal morbidity. Limited evidence suggests that dental support devices (DSD) may improve maternal valsalva and lead to a shortened second stage of labor by allowing them to push more effectively. Previous studies have been underpowered to find statistically significant results.
The Icahn School of Medicine at Mount Sinai has a unique and heterogeneous inner-city population of laboring mothers with marked rates of maternal obesity. The objective is to conduct a randomized controlled trial in which nulliparous patients are asked to use the LaboraideTM, a DSD designed for laboring women, while pushing with contractions in the second stage of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will give consent in the first stage of labor. Randomization will then be performed using sealed envelopes at the time of pushing in the second stage of labor. Duration of the second stage and time spent pushing will be recorded for both groups.
| Arm | Type | Receives |
|---|---|---|
| Laboraide TM dental support device | Experimental | Device: Laboraide TM dental support deviceReceive Laboraide |
| Control Group | No intervention | –Patients will give consent in the first stage of labor. Subsequently, randomization will be performed using sealed envelopes opened at the time of pushing in the second stage of labor. Women assigned to Group B will not receive a Laboraide TM dental support device. Duration of the second stage and time spent pushing will be recorded. Obstetric management will not be altered by group assignment. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Nulliparous women
- Non-anomalous fetus
- Singleton fetus
- Vertex presentation
- In the first phase of labor
Key exclusion criteria (11 listed)
- Multiparity
- History of prior uterine surgery such as cesarean section or myomectomy
- Unexplained vaginal bleeding
- Latex allergy
- Contraindication to vaginal delivery
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 |
|---|---|---|
| Laboraide TM dental support deviceAlso: Dental Device, Dental Support DevicePatients will give consent in the first stage of labor. Subsequently a randomization will be performed using sealed envelopes opened at the time of pushing in the second stage of labor. Women assigned to Group A will received a sealed Laboraide TM package. Duration of the second stage and time spent pushing will be recorded. Obstetric management will not be altered by group assignment. Following delivery, patients assigned to Group A will complete a patient satisfaction survey. | Device | Laboraide TM dental support device |
Primary outcome
Dilation Duration of Second Stage of Labor Time
Time frame: Up to 3 hours
At the time of pushing in the second stage of labor, the time from full dilation to delivery during the second stage of labor in patients with vaginal delivery (spontaneous, vacuum, forceps included). Intention to treat analysis.
Delivery Time
Time frame: An average of 75 minutes
The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed.
8 secondary outcomes
Dental Support Device Comfort and Patient Satisfaction
Time frame: Post-Op Day 1
Mode of Delivery
Time frame: Day 1
Estimated Blood Loss
Time frame: Day 1
Number of Participants With Post-partum Hemorrhage
Time frame: Day 1
Number of Participants With Chorioamnionitis
Time frame: Day 1
Neonatal Birth Weight
Time frame: Day 1
Neonatal Sex
Time frame: Day 1
Number of NICU Admission
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Angela Bianco, MD principal investigator
Icahn School of Medicine at Mount Sinai
Eric Bergh, MD study director
Ichan School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laboraide TM dental support device in people with Labor, run by Angela Bianco 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 7 inclusion and 11 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 11 Dec 2018. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dilation Duration of Second Stage of Labor Time (time frame: Up to 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Dec 2018.