Labor
Conditions
Keywords
Labor, Second stage, Dental device
Brief 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. 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.
Interventions
DEVICELaboraide TM 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.
Sponsors
Icahn School of Medicine at Mount Sinai
Angela Bianco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Nulliparous women * Non-anomalous fetus * Singleton fetus * Vertex presentation * In the first phase of labor * Full term gestation (\>=37w0d) * Maternal age 18-64 years
Exclusion criteria
* 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 * Fetal growth restriction * Fetus with suspected macrosomia * Prematurity (\<37 weeks gestational age) * Multiple gestation * Refusal to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dilation Duration of Second Stage of Labor Time | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Estimated Blood Loss | Day 1 | Estimated blood loss (EBL) during delivery |
| Number of Participants With Post-partum Hemorrhage | Day 1 | Number of participants with post-partum hemorrhage caused by uterine atony which is a loss of tone in the uterine musculature. |
| Number of Participants With Chorioamnionitis | Day 1 | Chorioamnionitis - an intra-amniotic infection (IAI) is an inflammation of the fetal membranes (amnion and chorion) due to a bacterial infection. |
| Dental Support Device Comfort and Patient Satisfaction | Post-Op Day 1 | 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 |
| Neonatal Sex | Day 1 | Neonatal outcomes - Number of male neonatal sex |
| Number of NICU Admission | Day 1 | Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions |
| Neonatal Birth Weight | Day 1 | Neonatal outcomes - birth weight |
| Mode of Delivery | Day 1 | Delivery Outcomes: Mode of delivery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Laboraide TM Dental Support Device Laboraide TM dental support device | 167 |
| Control Group No device | 171 |
| Total | 338 |
Baseline characteristics
| Characteristic | Total | Control Group | Laboraide TM Dental Support Device |
|---|---|---|---|
| Age, Customized Gestational Age at procedure 37.0 - 38.9 weeks | 65 Participants | 34 Participants | 31 Participants |
| Age, Customized Gestational Age at procedure 39.0 - 40.9 weeks | 224 Participants | 112 Participants | 112 Participants |
| Age, Customized Gestational Age at procedure 41.0 - 41.9 weeks | 49 Participants | 25 Participants | 24 Participants |
| Age, Customized Maternal Age 18-29 years | 114 Participants | 56 Participants | 58 Participants |
| Age, Customized Maternal Age 30-34 years | 156 Participants | 83 Participants | 73 Participants |
| Age, Customized Maternal Age 35-39 years | 59 Participants | 27 Participants | 32 Participants |
| Age, Customized Maternal Age 40+ years | 9 Participants | 5 Participants | 4 Participants |
| BMI at delivery 18-29 kg/m2 | 253 Participants | 127 Participants | 126 Participants |
| BMI at delivery 30-39 kg/m2 | 78 Participants | 43 Participants | 35 Participants |
| BMI at delivery 40+ kg/m2 | 7 Participants | 1 Participants | 6 Participants |
| Cervical dilation at admission >= 6 cm | 19 Participants | 7 Participants | 12 Participants |
| Epidural | 302 Participants | 154 Participants | 148 Participants |
| Indications for Admission Labor induction (intact membranes) | 85 Participants | 43 Participants | 42 Participants |
| Indications for Admission Premature rupture of membranes (PROM) | 62 Participants | 31 Participants | 31 Participants |
| Indications for Admission Spontaneous Labor | 191 Participants | 97 Participants | 94 Participants |
| Meconium at ROM | 50 Participants | 30 Participants | 20 Participants |
| Membrane Status | 71 Participants | 29 Participants | 42 Participants |
| Number anesthetic boluses administered in 2nd stage 0 | 260 Participants | 138 Participants | 122 Participants |
| Number anesthetic boluses administered in 2nd stage 1 | 29 Participants | 10 Participants | 19 Participants |
| Number anesthetic boluses administered in 2nd stage 2 | 7 Participants | 4 Participants | 3 Participants |
| Number anesthetic boluses administered in 2nd stage 3 | 6 Participants | 2 Participants | 4 Participants |
| Number of patients on pitocin in labor | 232 Participants | 122 Participants | 110 Participants |
| Preeclampsia with severe features on Magnesium | 5 Participants | 2 Participants | 3 Participants |
| Race/Ethnicity, Customized African American | 15 Participants | 7 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian | 24 Participants | 14 Participants | 10 Participants |
| Race/Ethnicity, Customized Hispanic | 37 Participants | 19 Participants | 18 Participants |
| Race/Ethnicity, Customized Other | 13 Participants | 3 Participants | 10 Participants |
| Race/Ethnicity, Customized White | 249 Participants | 128 Participants | 121 Participants |
| Sex: Female, Male Female | 338 Participants | 171 Participants | 167 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Delivery Time
The time from initiation of pushing until delivery during the second stage of labor. Intention to treat analysis will be performed.
Time frame: An average of 75 minutes
Population: Only those participants who delivered vaginally were included in the analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laboraide TM Dental Support Device | Delivery Time | 46 minutes |
| Control Group | Delivery Time | 53 minutes |
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.
Time frame: Up to 3 hours
Population: Only participants who delivered vaginally were included in the analysis
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laboraide TM Dental Support Device | Dilation Duration of Second Stage of Labor Time | 82 minutes |
| Control Group | Dilation Duration of Second Stage of Labor Time | 90 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
Time frame: Post-Op Day 1
Population: Only those who participated in survey was included
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Was the device comfortable | Strongly disagree | 11 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Was the device comfortable | Disagree | 15 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Was the device comfortable | Neither agree nor disagree | 15 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Was the device comfortable | Agree | 61 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Was the device comfortable | Strongly agree | 22 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Was this device helpful? | Strongly disagree | 10 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Was this device helpful? | Disagree | 12 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Was this device helpful? | Neither agree nor disagree | 27 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Was this device helpful? | Agree | 46 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Was this device helpful? | Strongly agree | 29 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Would you use the device again | Strongly disagree | 10 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Would you use the device again | Disagree | 20 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Would you use the device again | Neither agree nor disagree | 19 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Would you use the device again | Agree | 43 Participants |
| Laboraide TM Dental Support Device | Dental Support Device Comfort and Patient Satisfaction | Would you use the device again | Strongly agree | 32 Participants |
Secondary
Estimated Blood Loss
Estimated blood loss (EBL) during delivery
Time frame: Day 1
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Laboraide TM Dental Support Device | Estimated Blood Loss | 320 mL |
| Control Group | Estimated Blood Loss | 350 mL |
Secondary
Mode of Delivery
Delivery Outcomes: Mode of delivery
Time frame: Day 1
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Laboraide TM Dental Support Device | Mode of Delivery | Normal spontaneous vaginal delivery (NSVD) | 143 Participants |
| Laboraide TM Dental Support Device | Mode of Delivery | Forcep delivery | 11 Participants |
| Laboraide TM Dental Support Device | Mode of Delivery | Vacuum delivery | 7 Participants |
| Laboraide TM Dental Support Device | Mode of Delivery | Cesarean section | 6 Participants |
| Control Group | Mode of Delivery | Cesarean section | 10 Participants |
| Control Group | Mode of Delivery | Normal spontaneous vaginal delivery (NSVD) | 141 Participants |
| Control Group | Mode of Delivery | Vacuum delivery | 7 Participants |
| Control Group | Mode of Delivery | Forcep delivery | 13 Participants |
Secondary
Neonatal Birth Weight
Neonatal outcomes - birth weight
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laboraide TM Dental Support Device | Neonatal Birth Weight | 3343 grams | Standard Deviation 388 |
| Control Group | Neonatal Birth Weight | 3286 grams | Standard Deviation 371 |
Secondary
Neonatal Sex
Neonatal outcomes - Number of male neonatal sex
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laboraide TM Dental Support Device | Neonatal Sex | 85 Participants |
| Control Group | Neonatal Sex | 85 Participants |
Secondary
Number of NICU Admission
Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laboraide TM Dental Support Device | Number of NICU Admission | 17 Participants |
| Control Group | Number of NICU Admission | 14 Participants |
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.
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laboraide TM Dental Support Device | Number of Participants With Chorioamnionitis | 8 Participants |
| Control Group | Number of Participants With Chorioamnionitis | 16 Participants |
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.
Time frame: Day 1
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Laboraide TM Dental Support Device | Number of Participants With Post-partum Hemorrhage | 19 Participants |
| Control Group | Number of Participants With Post-partum Hemorrhage | 12 Participants |