Dental Support Device in the Second Stage of Labor
- Conditions
- Labor
- Interventions
- Device: Laboraide TM dental support device
- Registration Number
- NCT03138798
- Lead Sponsor
- Angela Bianco
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 348
- Nulliparous women
- Non-anomalous fetus
- Singleton fetus
- Vertex presentation
- In the first phase of labor
- Full term gestation (>=37w0d)
- Maternal age 18-64 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Laboraide TM dental support device Laboraide TM dental support device Receive Laboraide
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Number of NICU Admission Day 1 Neonatal outcomes: Number of neonatal intensive care unit (NICU) admissions
Mode of Delivery Day 1 Delivery Outcomes: Mode of delivery
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.
Neonatal Birth Weight Day 1 Neonatal outcomes - birth weight
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
Trial Locations
- Locations (1)
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States