Dental Support Device in the Second Stage of Labor

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Dental Support Device in the Second Stage of Labor at a Major Tertiary Care Center; A Randomized Controlled Trial

Conditions
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Labor

Intervention / Treatment
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* Device: Laboraide TM dental support device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Laboraide TM dental support device<br>Receive Laboraide | Device: Laboraide TM dental support device<br>* 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.<br>* Other names: Dental Support Device;|
| No Intervention: Control Group<br>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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Labor, Second stage, Dental device