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| Name | Class |
|---|---|
| Icahn School of Medicine at Mount Sinai | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laboraide TM dental support device | Experimental | Receive 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laboraide TM dental support device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | An average of 75 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Post-Op Day 1 |
| Mode of Delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Bianco, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Eric Bergh, MD | Ichan School of Medicine at Mount Sinai | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Laboraide TM Dental Support Device | Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the dental support device (DSD) while pushing. |
| FG001 | Control Group | no device |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Laboraide TM Dental Support Device | Laboraide TM dental support device |
| BG001 | Control Group | No device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only participants who delivered vaginally were included in the analysis | Posted | Median | Inter-Quartile Range | minutes | Up to 3 hours |
|
Adverse events not collected
Adverse events not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Laboraide TM Dental Support Device | Laboraide TM dental support device (a commercially available dental device made of soft plastic, 3 mm in thickness, which is inserted over the lower jaw with bite plates overlying the molar teeth) and were instructed to bite down on the DSD while pushing. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Bergh | Icahn School of Medicine at Mount Sinai | 908-625-8148 | eric.bergh@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2017 | Oct 30, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017090 | Occlusal Splints |
| ID | Term |
|---|---|
| D009989 | Orthotic Devices |
| D009983 | Orthopedic Equipment |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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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.
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|
Delivery Outcomes: Mode of delivery |
| Day 1 |
| Estimated Blood Loss | Estimated blood loss (EBL) during delivery | 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. | 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. | Day 1 |
| Neonatal Birth Weight | Neonatal outcomes - birth weight | Day 1 |
| Neonatal Sex | Neonatal outcomes - Number of male neonatal sex | Day 1 |
| Number of NICU Admission | Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions | Day 1 |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| BMI at delivery | Body Mass Index (BMI) at delivery | Count of Participants | Participants |
|
| Preeclampsia with severe features on Magnesium | Count of Participants | Participants |
|
| Indications for Admission | Count of Participants | Participants |
|
| Membrane Status | Rupture of membranes (ROM) prior to admission | Count of Participants | Participants |
|
| Meconium at ROM | Meconium at Rupture of Membranes (ROM) | Count of Participants | Participants |
|
| Cervical dilation at admission >= 6 cm | Count of Participants | Participants |
|
| Number of patients on pitocin in labor | Count of Participants | Participants |
|
| Epidural | Count of Participants | Participants |
|
| Number anesthetic boluses administered in 2nd stage | Only those participants who had an epidural were included | Count of Participants | Participants |
|
No device |
|
|
| Primary | Delivery Time | The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed. | Only those participants who delivered vaginally were included in the analysis | Posted | Median | Inter-Quartile Range | minutes | An average of 75 minutes |
|
|
|
| Secondary | 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 | Only those who participated in survey was included | Posted | Count of Participants | Participants | Post-Op Day 1 |
|
|
|
| Secondary | Mode of Delivery | Delivery Outcomes: Mode of delivery | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Estimated Blood Loss | Estimated blood loss (EBL) during delivery | Posted | Median | Inter-Quartile Range | mL | Day 1 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Neonatal Birth Weight | Neonatal outcomes - birth weight | Posted | Mean | Standard Deviation | grams | Day 1 |
|
|
|
| Secondary | Neonatal Sex | Neonatal outcomes - Number of male neonatal sex | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| Secondary | Number of NICU Admission | Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Control Group | No device | 0 | 0 | 0 | 0 | 0 | 0 |
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| 41.0 - 41.9 weeks |
|
| Asian |
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| Hispanic |
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| Other |
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| 40+ kg/m2 |
|
| Spontaneous Labor |
|
| 2 |
|
| 3 |
|
| Agree |
|
| Strongly agree |
|
| Was this device helpful? |
|
| Would you use the device again |
|
| Vacuum delivery |
|
| Cesarean section |
|